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

Launched by GENZYME, A SANOFI COMPANY · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.