NCT00652899 · STUDY IN CONTEXT

Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Detection of an absolute donor derived cell count of \> or = 100 cells/mL after NK cell infusion.

Source null

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secondary · POSTED

Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-\< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- \< or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of \< or = 1 new lesion.

Includes 12 patients that completed treatment per protocol criteria.

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secondary · POSTED

Median number of days from first date of treatment to date of disease progression (appearance of new metastatic lesions or objective tumor progression). Defined by computated tomography (CT) imaging based on Response Evaluation Criteria In Solid Tumors (RECIST): Progressive Disease (PD) \> or = 20% increase in sum of all target or any new lesions.

Source null

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secondary · POSTED

Median number of days patients alive from date of treatment to date of death or date of last follow-up if censored.

Source null

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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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id: NCT00652899
trial label: Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT00652899
outcome key
om-0000
source section id
NCT00652899-om-0000
source outcome index
0
endpoint
Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product
endpoint definition
Detection of an absolute donor derived cell count of \> or = 100 cells/mL after NK cell infusion.
time origin
Day 12-14
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-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT00652899
outcome key
om-0001
source section id
NCT00652899-om-0001
source outcome index
1
endpoint
Number of Patients Per Disease Response
endpoint definition
Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-\< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- \< or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of \< or = 1 new lesion.
time origin
1 Month After Natural Killer Cell Infusion (Day 30)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Includes 12 patients that completed treatment per protocol criteria.
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-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT00652899
outcome key
om-0002
source section id
NCT00652899-om-0002
source outcome index
2
endpoint
Median Number of Days to Progression
endpoint definition
Median number of days from first date of treatment to date of disease progression (appearance of new metastatic lesions or objective tumor progression). Defined by computated tomography (CT) imaging based on Response Evaluation Criteria In Solid Tumors (RECIST): Progressive Disease (PD) \> or = 20% increase in sum of all target or any new lesions.
time origin
From date of first treatment to disease progression
analysis role
secondary
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-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT00652899
outcome key
om-0003
source section id
NCT00652899-om-0003
source outcome index
3
endpoint
Median Overall Survival Number of Days Patients Alive After Treatment
endpoint definition
Median number of days patients alive from date of treatment to date of death or date of last follow-up if censored.
time origin
From first date on-study (treatment) to date of death
analysis role
secondary
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

arms

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT00652899
outcome key
om-0000
arm key
OG000
arm label
Ovarian/Fallopian Tube/Peritoneal Cancer Patients
regimen
This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and/or total body irradiation per protocol (200 Gy on Day 1 preceding natural killer cell infusion).
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00652899-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT00652899
outcome key
om-0001
arm key
OG000
arm label
No Total Body Irradiation
regimen
This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and no total body irradiation.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00652899-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT00652899
outcome key
om-0001
arm key
OG001
arm label
Total Body Irradiation
regimen
This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00652899-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT00652899
outcome key
om-0002
arm key
OG000
arm label
No Total Body Irradiation
regimen
This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and no total body irradiation.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00652899-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT00652899
outcome key
om-0002
arm key
OG001
arm label
Total Body Irradiation
regimen
This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00652899-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT00652899
outcome key
om-0003
arm key
OG000
arm label
Total Body Irradiation
regimen
This group includes patients that received chemotherapy, infusion of natural killer cells and total body irradiation per protocol.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00652899-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT00652899
outcome key
om-0003
arm key
OG001
arm label
No Total Body Irradiation
regimen
This group includes patients that received chemotherapy, infusion of natural killer cells and no total body irradiation per protocol.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00652899-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT00652899
harm key
EG000
source section id
NCT00652899-ae
event group key
EG000
event group label
All Patients Enrolled
serious affected
9
serious at risk
14
other affected
13
other at risk
14
frequency threshold
5
collection period
Serious adverse events were monitored through the follow-up period; death was followed for up to 2 years after Day 1 treatment.
event definition
Adverse event collection for the purposes of this study focused on targeted adverse events and unexpected adverse events at specific time points in relation to the NK cell infusion and post infusion IL-2 injections.
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

setting source links

Preserved source evidence · Not medical advice