TriangleNCT00068250 · STUDY IN CONTEXT
Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
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
A dose limiting toxicity (DLT) is defined as any grade 3 or 4 non-hematological toxicity (other than grade 3 nausea/vomiting) or any hematological toxicity resulting in the discontinuation of temozolomide. Toxicity evaluation for this dose escalation includes all toxicities occurring prior to the start of radiation therapy. If the patient did not receive radiation therapy, then toxicity evaluation included all toxicities occurring through week 15. Any grade 5 toxicity would result in immediate suspension of accrual.
Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (Please note that this outcome measure is considered the primary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
Tumor response was centrally reviewed. Complete response: Disappearance of all enhancing tumor, the patient must be off steroid therapy and neurologically stable or improved; partial response: ≥ 50% decrease in enhancing tumor; progressive disease: ≥ 25% increase in a lesion, progressive or newly emergent meningeal or ocular disease. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
Progression is defined as greater than 25% increase in enhancing tumor or the appearance of new lesions in the brain, eye, or the appearance of a new positive cerebrospinal fluid (CSF) cytology. The patient may be neurologically stable or worse and on stable or increasing doses of corticosteroid. Progression-free survival time is defined as time from registration to the date of progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
Reported safety
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-central-nervous-system-tumors
- nct id
- NCT00068250
- trial label
- Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
- 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
- 4
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00068250
- outcome key
- om-0000
- source section id
- NCT00068250-om-0000
- source outcome index
- 0
- endpoint
- Number of Phase I Participants Experiencing Toxicity
- endpoint definition
- A dose limiting toxicity (DLT) is defined as any grade 3 or 4 non-hematological toxicity (other than grade 3 nausea/vomiting) or any hematological toxicity resulting in the discontinuation of temozolomide. Toxicity evaluation for this dose escalation includes all toxicities occurring prior to the start of radiation therapy. If the patient did not receive radiation therapy, then toxicity evaluation included all toxicities occurring through week 15. Any grade 5 toxicity would result in immediate suspension of accrual.
- time origin
- From start of treatment to 10 weeks if radiation therapy received, to 15 weeks if not.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients on Phase I arms who started study treatment
- 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-central-nervous-system-tumors
- nct id
- NCT00068250
- outcome key
- om-0001
- source section id
- NCT00068250-om-0001
- source outcome index
- 1
- endpoint
- Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose)
- endpoint definition
- Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (Please note that this outcome measure is considered the primary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
- time origin
- Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients on Temozolomide 100 mg arms who started study treatment
- 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-central-nervous-system-tumors
- nct id
- NCT00068250
- outcome key
- om-0002
- source section id
- NCT00068250-om-0002
- source outcome index
- 2
- endpoint
- Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose)
- endpoint definition
- Tumor response was centrally reviewed. Complete response: Disappearance of all enhancing tumor, the patient must be off steroid therapy and neurologically stable or improved; partial response: ≥ 50% decrease in enhancing tumor; progressive disease: ≥ 25% increase in a lesion, progressive or newly emergent meningeal or ocular disease. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
- time origin
- From start of treatment to 10 weeks if RT received, to 15 weeks if not.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients on Temozolomide 100 mg arms who started study treatment and have scans for central review
- 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-central-nervous-system-tumors
- nct id
- NCT00068250
- outcome key
- om-0003
- source section id
- NCT00068250-om-0003
- source outcome index
- 3
- endpoint
- Phase II: Progression-free Survival (Including Phase I Patients at Same Dose)
- endpoint definition
- Progression is defined as greater than 25% increase in enhancing tumor or the appearance of new lesions in the brain, eye, or the appearance of a new positive cerebrospinal fluid (CSF) cytology. The patient may be neurologically stable or worse and on stable or increasing doses of corticosteroid. Progression-free survival time is defined as time from registration to the date of progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
- time origin
- Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients on Temozolomide 100 mg arms who started study treatment
- 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-central-nervous-system-tumors
- nct id
- NCT00068250
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Phase I: Temozolomide 100mg
- regimen
- Phase I: Temozolomide 100mg
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00068250-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00068250
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Phase I: Temozolomide150 mg
- regimen
- Phase I: Temozolomide 150 mg
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00068250-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00068250
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Combined Temozolomide 100mg Arms
- regimen
- Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
- analyzed count
- 53
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00068250-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00068250
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Combined Temozolomide 100mg Arms
- regimen
- Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00068250-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00068250
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Combined Temozolomide 100mg Arms
- regimen
- Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
- analyzed count
- 53
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00068250-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00068250
- harm key
- EG000
- source section id
- NCT00068250-ae
- event group key
- EG000
- event group label
- Phase I: Temozolomide 100 mg
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
- 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-central-nervous-system-tumors
- nct id
- NCT00068250
- harm key
- EG001
- source section id
- NCT00068250-ae
- event group key
- EG001
- event group label
- Phase I: Temozolomide 150 mg
- serious affected
- 4
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
- 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-central-nervous-system-tumors
- nct id
- NCT00068250
- harm key
- EG002
- source section id
- NCT00068250-ae
- event group key
- EG002
- event group label
- Phase II: Temozolomide 100 mg
- serious affected
- 16
- serious at risk
- 47
- other affected
- 47
- other at risk
- 47
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
- 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