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

This study has been completed.

Sponsored by: Genzyme
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002348
  Purpose

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 Intervention Phase
Lymphoma, Non-Hodgkin
HIV Infections
Drug: Mitoguazone
Phase II

MedlinePlus related topics:   AIDS    Lymphoma   

Drug Information available for:   Mitoguazone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison, Safety Study
Official Title:   Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002348

Locations
United States, Texas
ILEX Oncology Inc    
      San Antonio, Texas, United States, 782453217

Sponsors and Collaborators
Genzyme
  More Information


Publications:

Study ID Numbers:   241A, IDD-007
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002348
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Lymphoma, AIDS-related
Sexually Transmitted Diseases, Viral
Immunoproliferative Disorders
Acquired Immunodeficiency Syndrome
Lymphoma, small cleaved-cell, diffuse
Immunologic Deficiency Syndromes
Virus Diseases
Lymphatic Diseases
Mitoguazone
Lymphoma, AIDS-Related
HIV Infections
Sexually Transmitted Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Retroviridae Infections

Additional relevant MeSH terms:
Neoplasms
RNA Virus Infections
Neoplasms by Histologic Type
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Lentivirus Infections
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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