Non-Hodgkin's Lymphoma (NHL) Clinical Trial
Official title:
A Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20 Positive Non-Hodgkin's Lymphoma (NHL): Combining 90-Yttrium- Zevalin and the Redox- Modulating Agent, Motexafin Gadolinium (MGd)
Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate
cancer cells and either kill them or deliver radioactive cancer-killing substances to them
without harming normal cells. Motexafin gadolinium may increase the effectiveness of yttrium
Y 90 ibritumomab tiuxetan by making the cancer cells more sensitive to the drug.
This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when
administered with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they
work in treating patients with stage II, stage III, or stage IV relapsed or refractory
non-Hodgkin's lymphoma.
This is a phase I, dose-escalation study of motexafin gadolinium followed by a phase II
study. Patients are stratified according to extent of lymphomatous involvement (≤ 5% vs > 5
but ≤ 24% of cellular elements).
Cohorts of 3-6 patients in each stratum receive escalating doses of motexafin gadolinium
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which
2 of 6 patients experience dose-limiting toxicity (DLT) OR the dose preceding that at which 2
of 3 or 3 of 6 patients experience DLT.
- Once the MTD is determined, additional patients are treated at that dose level as in
phase I.
Patients are followed weekly for 3 months and then monthly for 5 years.
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