Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma

May 11, 2007 updated by: Pharmacyclics LLC.

Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
      • Stanford, California, United States, 94305
    • Florida
      • Miami, Florida, United States, 33136
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Maryland
      • Baltimore, Maryland, United States, 21231
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 years old
  • Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types
  • Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy
  • ECOG performance status score either 0 or 1
  • Willing and able to provide written informed consent

Exclusion Criteria:

Laboratory values of:

  • Platelet count < 50,000/µL
  • AST or ALT > 2 x the upper limit of normal (ULN)
  • Total bilirubin > 2 x ULN
  • Creatinine > 2.0 mg/dL

and

  • Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression)
  • Uncontrolled hypertension
  • Known history of porphyria, G6PD deficiency, HIV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical response rate

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Safety and tolerability
Duration of clinical response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Investigators

  • Principal Investigator: Brad Kahl, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 21, 2004

First Submitted That Met QC Criteria

June 22, 2004

First Posted (Estimate)

June 23, 2004

Study Record Updates

Last Update Posted (Estimate)

May 15, 2007

Last Update Submitted That Met QC Criteria

May 11, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCYC-0221

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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