Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome
Inclusion 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.