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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002348
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002348 on ClinicalTrials.gov Archive Site
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A Study of Mitoguazone Dihydrochloride in Patients With AIDS-Related Non-Hodgkin's Lymphoma
Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome

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).

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Lymphoma, Non-Hodgkin
  • HIV Infections
Drug: Mitoguazone
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Levine AM, Tulpule A, Tessman D, Kaplan L, Giles F, Luskey BD, Scadden DT, Northfelt DW, Silverberg I, Wernz J, Espina B, Von Hoff D. Mitoguazone therapy in patients with refractory or relapsed AIDS-related lymphoma: results from a multicenter phase II trial. J Clin Oncol. 1997 Mar;15(3):1094-103.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002348
241A, IDD-007
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Genzyme, a Sanofi Company
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NIH AIDS Clinical Trials Information Service
March 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP