Trial · NCT00068250
Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
NCT00068250, Phase 1, Phase 2, Completed, Radiation Therapy Oncology Group; results first posted 2018-02-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma. Trials, record NCT00068250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00068250
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
- NCT number
- NCT00068250
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Brain and Central Nervous System Tumors, Lymphoma
- Interventions
- rituximab, methotrexate, temozolomide 100 mg/m^2, temozolomide 150 mg/m^2, temozolomide 200 mg/m^2, radiation therapy, post-radiation therapy temozolomide
- First posted
- 2003-09-11
- Last updated
- 2018-02-07
- Results first posted
- 2018-02-07
- Limitations and caveats
The 200 mg/m\^2 treatment arm in the phase I component of the study did not open. Outcome measures are categorized as the phase I or phase II study component, but phase I patients at corresponding dose level are included in the phase II analyses.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Phase I Participants Experiencing Toxicity | From start of treatment to 10 weeks if radiation therapy received, to 15 weeks if not. | 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. |
| Primary | Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose) | Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years. | 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. ) |
| Secondary | Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose) | From start of treatment to 10 weeks if RT received, to 15 weeks if not. | 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. ) |
| Secondary | Phase II: Progression-free Survival (Including Phase I Patients at Same Dose) | Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years. | 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. ) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Phase I Participants Experiencing Toxicity | From start of treatment to 10 weeks if radiation therapy received, to 15 weeks if not. | Eligible patients on Phase I arms who started study treatment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose) | Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years. | Eligible patients on Temozolomide 100 mg arms who started study treatment | percentage of participants | NUMBER |
| SECONDARY | Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose) | From start of treatment to 10 weeks if RT received, to 15 weeks if not. | Eligible patients on Temozolomide 100 mg arms who started study treatment and have scans for central review | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase II: Progression-free Survival (Including Phase I Patients at Same Dose) | Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years. | Eligible patients on Temozolomide 100 mg arms who started study treatment | years | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Phase I Participants Experiencing Toxicity | Phase I: Temozolomide 100mg | 1 | Participants | ||
| Number of Phase I Participants Experiencing Toxicity | Phase I: Temozolomide150 mg | 3 | Participants | ||
| Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose) | Combined Temozolomide 100mg Arms | 80.8 | 95% Confidence Interval 70.1 to 91.5 | percentage of participants | |
| Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose) | Combined Temozolomide 100mg Arms | Complete Response | 18 | Participants | |
| Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose) | Combined Temozolomide 100mg Arms | Partial Response | 12 | Participants | |
| Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose) | Combined Temozolomide 100mg Arms | Progressive Disease | 2 | Participants | |
| Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose) | Combined Temozolomide 100mg Arms | Not evaluable | 3 | Participants | |
| Phase II: Progression-free Survival (Including Phase I Patients at Same Dose) | Combined Temozolomide 100mg Arms | 5.4 | 95% Confidence Interval 1.8 to 7.3 | years |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I: Dose Level 1 | STARTED | Phase I: Temozolomide 100 mg | 6 | |
| Phase I: Dose Level 1 | STARTED | Phase I: Temozolomide 150 mg | 0 | |
| Phase I: Dose Level 1 | STARTED | Phase I: Temozolomide 200 mg | 0 | |
| Phase I: Dose Level 1 | STARTED | Phase II: Temozolomide 100 mg | 0 | |
| Phase I: Dose Level 1 | COMPLETED | Phase I: Temozolomide 100 mg | 6 | |
| Phase I: Dose Level 1 | COMPLETED | Phase I: Temozolomide 150 mg | 0 | |
| Phase I: Dose Level 1 | COMPLETED | Phase I: Temozolomide 200 mg | 0 | |
| Phase I: Dose Level 1 | COMPLETED | Phase II: Temozolomide 100 mg | 0 | |
| Phase I: Dose Level 1 | NOT COMPLETED | Phase I: Temozolomide 100 mg | 0 | |
| Phase I: Dose Level 1 | NOT COMPLETED | Phase I: Temozolomide 150 mg | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events348
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hematologic-Other | Blood and lymphatic system disorders | Phase I: Temozolomide 100 mg | 0 | 6 | |
| other | Hematologic-Other | Blood and lymphatic system disorders | Phase I: Temozolomide 150 mg | 1 | 6 | |
| other | Hematologic-Other | Blood and lymphatic system disorders | Phase II: Temozolomide 100 mg | 2 | 47 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase I: Temozolomide 100 mg | 5 | 6 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase I: Temozolomide 150 mg | 6 | 6 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase II: Temozolomide 100 mg | 39 | 47 | |
| other | Hemolysis NOS | Blood and lymphatic system disorders | Phase I: Temozolomide 100 mg | 0 | 6 | |
| other | Hemolysis NOS | Blood and lymphatic system disorders | Phase I: Temozolomide 150 mg | 1 | 6 | |
| other | Hemolysis NOS | Blood and lymphatic system disorders | Phase II: Temozolomide 100 mg | 0 | 47 | |
| other | Platelet transfusion | Blood and lymphatic system disorders | Phase I: Temozolomide 100 mg | 2 | 6 |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: Temozolomide 100 mg | ||
| Total, all-cause mortality | Phase I: Temozolomide 150 mg | ||
| Total, all-cause mortality | Phase II: Temozolomide 100 mg | ||
| Total, other adverse events | Phase I: Temozolomide 100 mg | 6 | 6 |
| Total, other adverse events | Phase I: Temozolomide 150 mg | 6 | 6 |
| Total, other adverse events | Phase II: Temozolomide 100 mg | 47 | 47 |
| Total, serious adverse events | Phase I: Temozolomide 100 mg | 3 | 6 |
| Total, serious adverse events | Phase I: Temozolomide 150 mg | 4 | 6 |
| Total, serious adverse events | Phase II: Temozolomide 100 mg | 16 | 47 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27022122 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phase I: Temozolomide 100mg vs Phase I: Temozolomide150 mg: Number of Phase I Participants Experiencing Toxicity |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00068250
GET https://conductscience.org/api/trials/v1/NCT00068250/flow?page=2