Lymphoma Clinical Trial
Official title:
A Pilot Study Incorporating Motexafin Gadolinium (MGd) Into High-dose Methotrexate (MTX)-Based Chemo-immunotherapy and Radiation for Patients With Newly Diagnosed Primary CNS Lymphoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,
such as rituximab, can block cancer growth in different ways. Some block the ability of
cancer cells to grow and spread. Others find cancer cells and help kill them or carry
cancer-killing substances to them. Radiation therapy uses high-energy x-rays to kill cancer
cells. Motexafin gadolinium may make cancer cells more sensitive to radiation therapy and
combination chemotherapy. Giving motexafin gadolinium together with chemotherapy, rituximab,
and radiation therapy may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving motexafin gadolinium
together with combination chemotherapy, rituximab, and whole-brain radiation therapy and to
see how well it works in treating patients with newly diagnosed primary central nervous
system lymphoma.
OBJECTIVES:
Primary
- Determine the safety and efficacy of motexafin gadolinium (MGd) combined with high-dose
methotrexate-based chemotherapy and radiotherapy in patients with newly diagnosed
primary CNS lymphoma.
- Determine the toxicity of MGd and rituximab combined with high-dose methotrexate,
procarbazine hydrochloride, and vincristine (MPV) in these patients.
- Determine the toxicity of MGd in combination with whole-brain radiotherapy (WBRT) in
these patients.
- Determine the tumor-selective uptake of MGd.
Secondary
- Determine the overall response rate (complete remission [CR] and partial remission
[PR]) in patients treated with pre-radiotherapy and chemo-immunotherapy (R-MPV with
MGd).
- Determine the complete response rate in patients treated with this regimen.
- Determine the overall response rate (CR and PR) in patients who complete all MGd
combined with high-dose methotrexate-based chemotherapy and WBRT.
- Determine the event-free and overall survival at 1 year of patients treated with this
regimen.
- Determine the progression-free survival at 1 year of patients treated with this
regimen.
- Evaluate the neurotoxicity of R-MVP with MGd based on pre- and post-treatment
neuropsychologic testing.
OUTLINE:
- Tumor-selective imaging: Patients receive motexafin gadolinium (MGd) IV on days 1-2
beginning 1-2 weeks prior to induction therapy. They then undergo an MRI of the brain.
- Induction therapy: Patients receive methotrexate IV over 2-3 hours and vincristine IV
on day 1 and rituximab IV over 5 hours and MGd IV over 30-60 minutes on day 8. Patients
also receive oral procarbazine hydrochloride on days 1-7 of courses 1, 3, and 5.
Treatment repeats every 14 days for 5 courses in the absence of disease progression or
unacceptable toxicity. Patients with partial response receive an additional 2 courses
of induction therapy.
- Chemoradiotherapy: Beginning 4 weeks after completion of induction therapy, patients
undergo reduced-dose whole-brain radiotherapy for 6 weeks. Patients also receive MGd IV
over 30-60 minutes, beginning 2-5 hours prior to radiotherapy, for 10 days and then
every other day during radiotherapy.
- Consolidation therapy: After completion of chemoradiotherapy, patients receive
cytarabine IV over 3 hours on days 1-2. Treatment repeats every 30 days for 2 courses.
After completion of study therapy, patients are followed every 3 months for the first year,
every 3-4 months for the second year, every 4-6 months until the fifth year, and then
annually thereafter.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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