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NCT00068250 · ClinicalTrials.gov registry record · Phase 1
Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
A Phase 1 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00068250: Completed Phase 1 study, sponsored by Radiation Therapy Oncology Group.
NCT00068250 is a Phase 1 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00068250, a Phase 1 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy such as methotrexate and temozolomide use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining methotrexate, temozolomide, and rituximab with radiation therapy may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given together with methotrexate and rituximab followed by radiation therapy and to see how well they work in treating patients with primary central nervous system lymphoma.
Primary Outcome
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 s
Interventions
- DRUG rituximab
- DRUG methotrexate
- DRUG temozolomide 100 mg/m^2
- DRUG temozolomide 150 mg/m^2
- DRUG temozolomide 200 mg/m^2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2003-07 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT00068250 record still lists
NCT00068250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which rituximab is the first listed.
NCT00068250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00068250 about?
NCT00068250 is a clinical study titled "Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma". RATIONALE: Drugs used in chemotherapy such as methotrexate and temozolomide use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without har...
What is the current status of trial NCT00068250?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2003-07. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00068250?
The interventions under investigation include: rituximab (DRUG), methotrexate (DRUG), temozolomide 100 mg/m^2 (DRUG), temozolomide 150 mg/m^2 (DRUG), temozolomide 200 mg/m^2 (DRUG).
Who is sponsoring clinical trial NCT00068250?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00068250's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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