Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Sarcoma, Kaposi
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To define the best doses of sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ), interferon alfa-2b ( IFN-A2b ), and zidovudine ( AZT ) to give together in patients with AIDS-ass...
Detailed Description
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 pat...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
August 1 1992
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00000694
End Date
August 1 1992
Last Update
November 2 2021
Active Locations (1)
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1
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021