NCT01362790 · STUDY IN CONTEXT

SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Response was assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is complete disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

→

primary · POSTED

Development of antibodies following treatment with SS1P. The goal was to delay development of antibodies to SS1P so a patient could get a second cycle of therapy with SS1P.

No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

→

primary · POSTED

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

→

primary · POSTED

Should any 2 patients within the first 3 to 6 patients experience treatment limiting toxicity requiring cessation of treatment prior to the conclusion of the first cycle, the maximum tolerated dose will have been exceeded and patients will be enrolled to the next lower dose.

Source null

→

secondary · POSTED

The Kaplan-Meier was used to determine the probability of overall survival from on-study date until death or last follow-up (calculated from the date of study entry until the date of analysis).

No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

→

secondary · POSTED

Defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).

No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Response Assessment

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-pancreatic-cancer
nct id: NCT01362790
qol key: qol-0000
source section id: NCT01362790-om-0000
source outcome index: 0
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Response Assessment
measure definition: Response was assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is complete disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
time frame: 52 months and 4 days
analysis role: primary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Progression-free Survival

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-pancreatic-cancer
nct id: NCT01362790
qol key: qol-0005
source section id: NCT01362790-om-0005
source outcome index: 5
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Progression-free Survival
measure definition: Defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).
time frame: 36 months
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Duration of Response

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-pancreatic-cancer
nct id: NCT01362790
qol key: qol-0006
source section id: NCT01362790-om-0006
source outcome index: 6
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Duration of Response
measure definition: DOR is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is measured from the time measurement criteria is met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to\<10mm. partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study).
time frame: up to 2.5 years
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: In months; the only 3 responders were in group one, thus arm/groups 2-7 are not shown here.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-pancreatic-cancer
nct id: NCT01362790
trial label: SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 7
qol Count: 3

outcomes

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0000
source section id
NCT01362790-om-0000
source outcome index
0
endpoint
Response Assessment
endpoint definition
Response was assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is complete disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
time origin
52 months and 4 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0001
source section id
NCT01362790-om-0001
source outcome index
1
endpoint
Count of Participants With SS1P Antibody Formation
endpoint definition
Development of antibodies following treatment with SS1P. The goal was to delay development of antibodies to SS1P so a patient could get a second cycle of therapy with SS1P.
time origin
On last day of last dosing cycle, end of cycle 1 (day 30)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0002
source section id
NCT01362790-om-0002
source outcome index
2
endpoint
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered SS1P and Pentostatin or Cyclophosphamide
endpoint definition
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
time origin
Date treatment consent signed to date off study, approximately 64 months and 26 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0003
source section id
NCT01362790-om-0003
source outcome index
3
endpoint
Recommended Phase 2 Dose (RP2D) in Drug Lot FIL129J01
endpoint definition
Should any 2 patients within the first 3 to 6 patients experience treatment limiting toxicity requiring cessation of treatment prior to the conclusion of the first cycle, the maximum tolerated dose will have been exceeded and patients will be enrolled to the next lower dose.
time origin
Days 1, 3, and 5 of a 21 day cycle
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0004
source section id
NCT01362790-om-0004
source outcome index
4
endpoint
Overall Survival
endpoint definition
The Kaplan-Meier was used to determine the probability of overall survival from on-study date until death or last follow-up (calculated from the date of study entry until the date of analysis).
time origin
36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0005
source section id
NCT01362790-om-0005
source outcome index
5
endpoint
Progression-free Survival
endpoint definition
Defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).
time origin
36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0000
arm key
OG000
arm label
Mesothelioma Pilot Phase Regimen A
regimen
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01362790-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0000
arm key
OG001
arm label
Mesothelioma Pilot Phase Regimen
regimen
Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01362790-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0000
arm key
OG002
arm label
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
regimen
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01362790-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0000
arm key
OG003
arm label
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
regimen
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01362790-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0000
arm key
OG004
arm label
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
regimen
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01362790-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0000
arm key
OG005
arm label
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
regimen
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01362790-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0001
arm key
OG000
arm label
Mesothelioma Pilot Phase Regimen A
regimen
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01362790-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0001
arm key
OG001
arm label
Mesothelioma Pilot Phase Regimen B
regimen
Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01362790-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0001
arm key
OG002
arm label
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
regimen
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01362790-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0001
arm key
OG003
arm label
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
regimen
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01362790-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0001
arm key
OG004
arm label
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
regimen
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01362790-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
outcome key
om-0001
arm key
OG005
arm label
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
regimen
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01362790-om-0001#groups/OG005

harms

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
harm key
EG000
source section id
NCT01362790-ae
event group key
EG000
event group label
Mesothelioma Pilot Phase Regimen A
serious affected
6
serious at risk
11
other affected
11
other at risk
11
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 64 months and 26 days.
event definition
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
harm key
EG001
source section id
NCT01362790-ae
event group key
EG001
event group label
Mesothelioma Pilot Phase Regimen B
serious affected
8
serious at risk
8
other affected
8
other at risk
8
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 64 months and 26 days.
event definition
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
harm key
EG002
source section id
NCT01362790-ae
event group key
EG002
event group label
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
serious affected
3
serious at risk
7
other affected
7
other at risk
7
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 64 months and 26 days.
event definition
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
harm key
EG003
source section id
NCT01362790-ae
event group key
EG003
event group label
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
serious affected
9
serious at risk
15
other affected
15
other at risk
15
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 64 months and 26 days.
event definition
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
harm key
EG004
source section id
NCT01362790-ae
event group key
EG004
event group label
Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A
serious affected
1
serious at risk
8
other affected
8
other at risk
8
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 64 months and 26 days.
event definition
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
harm key
EG005
source section id
NCT01362790-ae
event group key
EG005
event group label
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 64 months and 26 days.
event definition
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
harm key
EG006
source section id
NCT01362790-ae
event group key
EG006
event group label
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 64 months and 26 days.
event definition
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
qol key
qol-0000
source section id
NCT01362790-om-0000
source outcome index
0
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Response Assessment
measure definition
Response was assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is complete disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
time frame
52 months and 4 days
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
qol key
qol-0005
source section id
NCT01362790-om-0005
source outcome index
5
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Progression-free Survival
measure definition
Defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).
time frame
36 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT01362790
qol key
qol-0006
source section id
NCT01362790-om-0006
source outcome index
6
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Duration of Response
measure definition
DOR is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is measured from the time measurement criteria is met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to\<10mm. partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study).
time frame
up to 2.5 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
In months; the only 3 responders were in group one, thus arm/groups 2-7 are not shown here.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice