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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00086034
First Posted: June 23, 2004
Last Update Posted: May 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pharmacyclics LLC.
  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
Intervention Model: Single Group Assignment
Masking: None (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 LLC.:

Primary Outcome Measures:
  • Clinical response rate

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

Estimated Enrollment: 35
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 LLC.
Investigators
Principal Investigator: Brad Kahl, MD University of Wisconsin, Madison
  More Information

ClinicalTrials.gov Identifier: NCT00086034     History of Changes
Other Study ID Numbers: PCYC-0221
First Submitted: June 21, 2004
First Posted: June 23, 2004
Last Update Posted: May 15, 2007
Last Verified: May 2007

Keywords provided by Pharmacyclics LLC.:
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
Photosensitizing Agents
Dermatologic Agents