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

This study has been completed.
Sponsor:
Information provided by:
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00086034
First received: June 21, 2004
Last updated: May 11, 2007
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Lymphoma
Non-Hodgkin's Lymphoma
Drug: Motexafin gadolinium
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Pharmacyclics:

Primary Outcome Measures:
  • Clinical response rate

Secondary Outcome Measures:
  • Progression-free survival
  • Duration of clinical response
  • Safety and tolerability

Estimated Enrollment: 35
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086034

Locations
United States, California
San Diego, California, United States, 92121
Stanford, California, United States, 94305
United States, Florida
Miami, Florida, United States, 33136
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Maryland
Baltimore, Maryland, United States, 21231
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Pharmacyclics
Investigators
Principal Investigator: Brad Kahl, MD University of Wisconsin, Madison
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00086034     History of Changes
Other Study ID Numbers: PCYC-0221
Study First Received: June 21, 2004
Last Updated: May 11, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacyclics:
Lymphoma
Non-Hodgkin's Lymphoma
Indolent lymphoma
Relapsed lymphoma
Refractory lymphoma
Motexafin gadolinium

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Motexafin gadolinium
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014