Clinical Trial RTOG 1114
- Phase II Randomized Study of Rituximab, Methotrexate, Procarbazine, Vincristine & Cytarabine with and without Low-Dose Whole-Brain Radiotherapy for Primary Central Nervous System Lymphoma
- Principal Investigator
- Jeffrey Raizer
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.RTOG 1114
- This is a randomized investigational study is to determine the effects, good and/or bad, of the combination of low-dose whole brain radiation plus chemotherapy on PCNSL (Primary Central Nervous System Lymphoma) and tumor versus chemotherapy alone.
- PCNSL can be cured in less than half of patients with a combination of chemotherapy and standard brain radiation. Unfortunately, the combination of chemotherapy and standard brain radiation may cause serious damage to the brain, such as progressive memory and neurologic problems that can be fatal. As a new alternative, radiotherapy has been used in significantly lower doses. In a previous study, this seemed to achieve the same rates of cure as full doses of radiotherapy but with much less risk of neurologic side effects.
Some of the eligibility criteria include:
- Participants must have B-cell non-Hodgkin's lymphoma involving the brain with no evidence of systemic involvement.
- Participants must be 18 years of age or older.
- Participants must not have had prior chemotherapy for CNS lymphoma or prior brain/cranial irradiation.
- Description of Treatment
- Participants on this study will be "randomized" into one of two study groups. Participants in both ARMs (1 and 2) will receive chemotherapy with rituximab, methotrexate (MTX), procarbazine, and vincristine. The treatment will be broken up into 28-day periods called cycles. Participants will have 4 cycles on this chemotherapy regimen. After the 4 cycles, participants in Arm 1 will receive two 28-day cycles of chemotherapy with Cytarabine. Participants in ARM 2, if there is no tumor growth (of existing tumor) during the chemotherapy, will then receive the reduced-dose radiation therapy to their brain daily for a total of 13 days. After completion of the radiation therapy, ARM 2 participants will receive two 28-day cycles of chemotherapy with Cytarabine.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 09-Feb-16 01:35 AM
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