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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)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma (NHL)

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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 UniversityChicago, Illinois  60611
Jesse B. Brown Veterans Affairs Medical CenterChicago, Illinois  60611