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← recurrent Central Nervous System Tumors

NCT00074165 · STUDY IN CONTEXT

Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen

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

Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.

Source null

→

secondary · POSTED

Overall survival is measured from entry onto study until death from any cause or until death or progression of disease, respectively.

Data not collected due to low accrual and early termination.

→

secondary · POSTED

Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression

Data not collected due to low accrual and early termination.

→

secondary · POSTED

Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months

Data not collected due to low accrual and early termination.

→

secondary · POSTED

Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment

Data not collected due to low accrual and early termination.

→

secondary · POSTED

Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment

Data not collected due to low accrual and early termination.

→

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 · Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months

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-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT00074165
qol key
qol-0003
source section id
NCT00074165-om-0003
source outcome index
3
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months
measure definition
Source null
time frame
5 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Data not collected due to low accrual and early termination.
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-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT00074165
trial label
Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen
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
6
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    outcome key
    om-0000
    source section id
    NCT00074165-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.
    endpoint definition
    Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.
    time origin
    2 years
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    outcome key
    om-0001
    source section id
    NCT00074165-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Overall Survival Assessed by Clinical and Radiographic Response
    endpoint definition
    Overall survival is measured from entry onto study until death from any cause or until death or progression of disease, respectively.
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data not collected due to low accrual and early termination.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    outcome key
    om-0002
    source section id
    NCT00074165-om-0002
    source outcome index
    2
    endpoint
    Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression
    endpoint definition
    Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data not collected due to low accrual and early termination.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    outcome key
    om-0003
    source section id
    NCT00074165-om-0003
    source outcome index
    3
    endpoint
    Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months
    endpoint definition
    Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data not collected due to low accrual and early termination.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    outcome key
    om-0004
    source section id
    NCT00074165-om-0004
    source outcome index
    4
    endpoint
    Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment
    endpoint definition
    Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment
    time origin
    2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data not collected due to low accrual and early termination.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    outcome key
    om-0005
    source section id
    NCT00074165-om-0005
    source outcome index
    5
    endpoint
    Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment
    endpoint definition
    Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment
    time origin
    2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data not collected due to low accrual and early termination.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Rituximab and Carboplatin
    regimen
    Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2
    analyzed count
    17
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074165-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Rituximab and Carboplatin
    regimen
    Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074165-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Rituximab and Carboplatin
    regimen
    Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074165-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Rituximab and Carboplatin
    regimen
    Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074165-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Rituximab and Carboplatin
    regimen
    Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074165-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Rituximab and Carboplatin
    regimen
    Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074165-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    harm key
    EG000
    source section id
    NCT00074165-ae
    event group key
    EG000
    event group label
    Rituximab and Carboplatin
    serious affected
    16
    serious at risk
    17
    other affected
    1
    other at risk
    17
    frequency threshold
    5
    collection period
    During study treatment (1 year).
    event definition
    Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT00074165
    qol key
    qol-0003
    source section id
    NCT00074165-om-0003
    source outcome index
    3
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months
    measure definition
    Source null
    time frame
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Data not collected due to low accrual and early termination.
    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