A Randomized Phase II Trial to Determine the Safety, Tolerance, and Efficacy of Two Doses of Interferon Alfa-2b Combined With Didanosine in Patients With Kaposi's Sarcoma

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

- Chemoprophylaxis for candidiasis and herpes simplex.

- Up to 14 days of metronidazole.

- Recombinant erythropoietin.

- G-CSF (for severe cases of neutropenia).

- Isoniazid for treatment of TB if given in conjunction with pyridoxine.

Required in patients with CD4 counts < 200 cells/mm3:

- Prophylaxis for PCP.

PER AMENDMENT 9/19/96:

- After the first 16 weeks of combined IFN alpha-2b and ddI treatment subjects may at
the discretion of the investigator receive any FDA approved antiretroviral drug
regimen in addition to or in place of ddI.

Patients must have:

- Positive antibody to HIV.

- Biopsy-proven Kaposi's sarcoma (at least 5 measurable lesions, with at least 1
measurable cutaneous lesion) involving the skin, lymph nodes, oral cavity, or
asymptomatic lesions of the GI tract not requiring systemic chemotherapy. Lung
involvement with Kaposi's sarcoma excludes.

- Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

- Concurrent opportunistic infection or B symptoms including unexplained fever, night
sweats, weight loss > 10 percent, and diarrhea lasting more than 2 weeks.

- Visceral (non-nodal) Kaposi's sarcoma requiring cytotoxic chemotherapy.

- Severe (> 2+) tumor-associated edema.

- Concurrent neoplasia other than basal cell carcinoma, or anogenital intraepithelial
neoplasia.

- Current clinical evidence of peripheral neuropathy (= or > grade 1), pancreatitis,
intractable diarrhea, or active seizure disorder not well controlled by anti-seizure
medications.

- Significant symptomatic cardiac disease.

- Medical contraindication.

Concurrent Medication:

Excluded:

- Other investigational, antiviral, immunomodulating, or antitumor agents.

- Drugs associated with peripheral neuropathy (other than ddI).

PER AMENDMENT 9/19/96:

- Other antiretroviral agents may not be taken during the first 16 weeks of combined
IFN alpha-2b and ddI treatment.

Concurrent Treatment:

Excluded:

- Radiation therapy.

Patients with the following prior conditions are excluded:

- Opportunistic infection or B symptoms including unexplained fever, night sweats,
weight loss > 10 percent, and diarrhea lasting more than 2 weeks.

- Prior grade 3 or 4 toxicity attributed to ddI therapy.

- Prior history of peripheral neuropathy (= or > grade 1), pancreatitis, intractable
diarrhea, or active seizure disorder not well controlled by anti-seizure medications.

- History of myocardial infarction or ventricular arrhythmias.

Prior Medication:

Excluded:

- Prior IFN-alpha.

- Corticosteroids, biological response modifiers, cytotoxic chemotherapy, or known
neurotoxic drugs (other than ddI or ddC) within 30 days prior to study entry.

- Therapy with antiretroviral drugs (other than ddI) within 7 days prior to study
entry.

Prior Treatment:

Excluded:

- Radiation therapy within 30 days prior to study entry.

Risk Behavior:

- Alcohol consumption is strongly discouraged.

- Patients considered to be noncompliant should be excluded.