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

Genzyme

Status and phase: Completed; Phase 2

Conditions: HIV Infections; Lymphoma, Non-Hodgkin

Treatments: Drug: Mitoguazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002348

IDD-007

241A

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.