Status:
COMPLETED
A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Sarcoma, Kaposi
HIV Infections
Eligibility:
All Genders
14+ years
Phase:
PHASE1
Brief Summary
To determine the safety as well as the most effective dose of sargramostim (GM-CSF; granulocyte-macrophage colony stimulating factor) that will prevent the side effects caused by the combined use of z...
Detailed Description
Patients included in this study have KS, which is a type of cancer that occurs in nearly 20 percent of patients with AIDS. AIDS patients with extensive KS require treatment with effective cytotoxic (a...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Non-steroidal agents such as acetaminophen for drug-related fevers.
- Pentamidine inhalation prophylaxis for Pneumocystis carinii pneumonia (PCP) in patients with a prior history or a T4 count < 200 cells/mm3.
- Antiemetics for nausea, vomiting.
- Symptomatic treatment for grades 1 and 2 oral toxicity.
- Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults).
Patients must have newly diagnosed biopsy-proven advanced AIDS-related Kaposi's sarcoma.
Exclusion Criteria
Concurrent Medication:
Excluded:
- Systemic steroids for > 1 week in any 30 days.
- All known marrow-suppressive agents.
- Any other investigational drugs.
Patients will be excluded from the study for the following reasons:
- The presence of other active malignancies except basal cell carcinoma of the skin and in situ uterine cancer.
- Alteration of mental status that may not permit compliance with the protocol.
- Symptomatic sensory or motor neuropathy.
- History of myocardial infarction or significant arrhythmias.
- Class III/IV functional capacity in cardiac patients.
Prior Medication:
Excluded:
- Cytotoxic chemotherapy.
Excluded within 1 week of study entry:
- Therapy for Kaposi's sarcoma, including interferons, immunomodulators, antiretroviral agents.
Patients may not have any of the following diseases or symptoms:
- Allergy to bleomycin.
- The presence of other active malignancies except basal cell carcinoma of the skin and in situ uterine cancer.
- Alteration of mental status that may not permit compliance with the protocol.
- Symptomatic sensory or motor neuropathy.
- History of myocardial infarction or significant arrhythmias.
- Class III/IV functional capacity in cardiac patients.
- Concurrent serious infections, such as Pneumocystis carinii pneumonia (PCP), toxoplasma brain abscess, cytomegalovirus (CMV) retinitis or colitis, cryptococcal meningitis, and symptomatic Mycobacterium avium- intracellulare (MAI).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 1993
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00000681
End Date
October 1 1993
Last Update
November 3 2021
Active Locations (5)
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1
USC CRS
Los Angeles, California, United States, 900331079
2
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
3
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States, 02215
4
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States, 14215