Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genzyme, a Sanofi Company
Treatments:
Mitoguazone
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.