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)
18 Years
N/A
Both
Non-Hodgkin's Lymphoma (NHL)
Trial Information
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
phase I.
Patients are followed weekly for 3 months and then monthly for 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of one of the following:
- Low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL)
- The following histologies are eligible:
- Small lymphocytic lymphoma
- Lymphoplasmacytoid lymphoma
- Follicular center grades 1, 2, or 3 lymphoma
- Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid
tissue type
- Nodal marginal zone B-cell lymphoma
- Relapsed or refractory after 2 prior treatment regimens or 1 anthracycline
regimen
- Diffuse large B-cell NHL or mantle cell lymphoma in first or second relapse
- Transformed NHL, defined as low-grade NHL transformed to diffuse large B-cell
lymphoma, with no more than 1 relapse since transformation
Age 18 and over Recovered from prior immunotherapy Life expectancy At least 3 months
Recovered from prior chemotherapy
- More than 4 weeks since prior major surgery and recovered
- More than 4 weeks since prior anticancer therapy recovered from prior radiotherapy
Exclusion criteria:
No major bleeding within the past 4 weeks No uncontrolled hypertension No stroke within
the past 4 weeks
- No active infection
- No other active nonmalignant disease
- No known G6PD deficiency
- No history of porphyria
- No other condition that would preclude study participation
- No human anti-mouse antibodies
- No known history of HIV
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior radioimmunoconjugate therapy
- No prior exposure to murine antibodies other than rituximab
- More than 4 weeks since prior rituximab
- No history of failed stem cell collection
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Outcome Description:
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
Outcome Time Frame:
On each treatment day (2, 3, 4, 9, 10, 11) and Day 7 evaluation
Safety Issue:
Yes
Principal Investigator
Andrew M. Evens, DO, MS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Northwestern University
Authority:
United States: Food and Drug Administration
Study ID:
NU 02H8
NCT ID:
NCT00089284
Start Date:
September 2003
Completion Date:
April 2012
Related Keywords:
- Non-Hodgkin's Lymphoma (NHL)
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Northwestern University | Chicago, Illinois 60611 |
| Jesse B. Brown Veterans Affairs Medical Center | Chicago, Illinois 60611 |
