A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (rHuGM-CSF), Recombinant Alpha Interferon and Azidothymidine (AZT) in AIDS-Associated Kaposi's Sarcoma

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Studies show that IFN-A2b can cause KS tumors to shrink or disappear in about 30 percent of patients. IFN-A2b can greatly reduce the growth of the HIV virus in test tube experiments and perhaps in patients. AZT has also been shown to reduce the growth of HIV and show improvements in the immune system with fewer infections. Test tube experiments show that when IFN-A2b and AZT are used together, they reduce the growth of the HIV virus much more effectively than when either drug is used alone. In recent studies of the combination of interferon alpha and AZT in patients with KS, more than 40 pe...

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Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Prophylaxis for Pneumocystis carinii pneumonia (PCP) with aerosolized pentamidine. Ibuprofen, not to exceed 1600 mg/day, for fever or analgesia.
• • Biopsy-proven Kaposi's sarcoma confined to the skin, lymph nodes, or non-nodular lesions of the hard palate. Positive antibody to HIV confirmed by any federally licensed ELISA test kit. Patients must be able to give informed consent.
• • Allowed: Basal cell carcinoma.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following are excluded:
• • Prior or concurrent opportunistic infection or B symptoms (unexplained fever, night sweats, \> 10 percent involuntary weight loss or diarrhea persisting \> 2 weeks).
• • Visceral (non-nodal) Kaposi's sarcoma including extensive oral lesions.
• • Severe (\> 2+) tumor-associated edema.
• • Concurrent neoplasia (excluding basal cell carcinoma).
• • Significant cardiac disease (New York Heart Association class III or IV) or history of myocardial infarction o significant cardiac arrhythmias.
• • Dementia (= or \> stage 2).
• Concurrent Medication:
• Excluded:
• • Any systemic chemoprophylaxis not specifically allowed.
• • Aspirin and acetaminophen.
• • Nonsteroidal anti-inflammatory agents not specifically allowed.
• • Corticosteroids.
• • Barbiturates.
• • Other antiviral agents, immunotherapy, hormonal therapy, chemotherapy directed at treatment of viral infection or malignancy.
• • Other investigational agents.
• Concurrent Treatment:
• Excluded:
• • Radiation therapy directed at treatment of viral infection or malignancy.
• Patients with the following are excluded:
• • Prior or concurrent opportunistic infection or B symptoms (unexplained fever, night sweats, \> 10 percent involuntary weight loss or diarrhea persisting \> 2 weeks).
• • Visceral (non-nodal) Kaposi's sarcoma including extensive oral lesions.
• • Severe (\> 2+) tumor-associated edema.
• • Concurrent neoplasia (excluding basal cell carcinoma).
• • Significant cardiac disease (New York Heart Association class III or IV) or history of myocardial infarction or significant cardiac arrhythmias.
• • Dementia (= or \> stage 2).
• Prior Medication:
• Excluded:
• • Interferon alpha-2b.
• • Granulocyte-macrophage colony-stimulating factor (GM-CSF).
• • Prior grade 3 or grade 4 toxicity during AZT therapy.
• * Excluded within 30 days of study entry:
• • Zidovudine (AZT).
• • Corticosteroids.
• • Biologic response modifiers.
• • Cytotoxic chemotherapy.
• • Antiretroviral agents.
• • Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults).
• Prior Treatment:
• Excluded within 30 days of study entry:
• • Requirement for red blood cell transfusions within 30 days of study entry.
• • Radiation therapy.
• • Active drug or alcohol abuse.