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A Study of Mitoguazone Dihydrochloride in Patients With AIDS-Related Non-Hodgkin's Lymphoma

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.
ClinicalTrials.gov Identifier: NCT00002348
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:
To estimate the response rate, response duration, clinical benefit, and toxicity of mitoguazone dihydrochloride (MGBG) in patients with AIDS-related refractory or relapsing non-Hodgkin's lymphoma (NHL).

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin HIV Infections Drug: Mitoguazone Phase 2

Detailed Description:
Patients receive infusions of MGBG on days 1 and 8 and every 2 weeks thereafter. It is suggested that a lumbar puncture be performed to evaluate for leptomeningeal disease.

Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Lymphoma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • HIV positivity by ELISA confirmed by Western blot.
  • AIDS-related NHL that is refractory or relapsed.
  • Life expectancy of at least 12 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Concomitant malignancy OTHER THAN curatively treated carcinoma in situ of the cervix; basal or squamous cell carcinoma of the skin; or non-active, non-visceral Kaposi's sarcoma not requiring active chemotherapy.
  • Active uncontrolled bacterial infection, viral infection (other than herpes simplex), or fungal infection (other than oropharyngeal candidiasis) that requires treatment within 2 weeks of study entry.
  • Significant cardiovascular disease.

Concurrent Medication:

Excluded:

  • Hormonal therapy (except medications given for muscle wasting, such as testosterone or Megace).
  • Other chemotherapy.
  • Investigational anti-cancer drugs.

Concurrent Treatment:

Excluded:

  • Concomitant radiation to sites other than CNS.

Patients with the following prior conditions are excluded:

Prior malignancy OTHER THAN curatively treated carcinoma in situ of the cervix; basal or squamous cell carcinoma of the skin; or non-active, non-visceral Kaposi's sarcoma not requiring active chemotherapy.

Recommended:

  • Prophylaxis for PCP and oral candidiasis.

Required in patients with leptomeningeal disease:

  • Intrathecal methotrexate or cytarabine (Ara-C).
  • Leucovorin.

Required in patients with leptomeningeal disease:

Cranial radiation to a helmet field.

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): NCT00002348


Locations
United States, Texas
ILEX Oncology Inc
San Antonio, Texas, United States, 782453217
Sponsors and Collaborators
Genzyme, a Sanofi Company
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002348     History of Changes
Other Study ID Numbers: 241A
IDD-007
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:
Lymphoma, Non-Hodgkin
Acquired Immunodeficiency Syndrome
Lymphoma, AIDS-Related
Mitoguazone

Additional relevant MeSH terms:
Lymphoma
HIV Infections
Lymphoma, Non-Hodgkin
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Mitoguazone
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action