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

Completed · Phase 2

Conditions studied: Lymphoma, Non-Hodgkin, HIV Infections

In brief

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).

Key facts

Study ID

NCT00002348

Run by

Genzyme, a Sanofi Company

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ILEX Oncology Inc — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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