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)
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
Patients are followed weekly for 3 months and then monthly for 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
To determine the maximally tolerated dose and dose-limiting toxicity of MGd in combination with Rituxan, 111Indium-Zevalin, and 90Yttrium- Zevalin using a modified Fibonacci phase I study design (with patient allocation based on amount of lymphoma bone marrow involvement
On each treatment day (2, 3, 4, 9, 10, 11) and Day 7 evaluation
Andrew M. Evens, DO, MS
United States: Food and Drug Administration
|Northwestern University||Chicago, Illinois 60611|
|Jesse B. Brown Veterans Affairs Medical Center||Chicago, Illinois 60611|