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

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.

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.