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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome

Conditions
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Lymphoma, Non-Hodgkin, HIV Infections

Intervention / Treatment
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* Drug: Mitoguazone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mitoguazone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Non-Hodgkin, Acquired Immunodeficiency Syndrome, Lymphoma, AIDS-Related, Mitoguazone