A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma
Completed · Phase 1
Conditions studied: Sarcoma, Kaposi, HIV Infections
In brief
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 zidovudine (AZT) and various doses of cancer-fighting drugs (doxorubicin, bleomycin, and vincristine) in AIDS patients with Kaposi's sarcoma (KS). 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 (anti-cancer) agents to reduce the tumor size and with antiretroviral agents such as AZT to prevent or ameliorate the development of opportunistic infections. Due to the significant toxic effect of both cytotoxic and antiviral agents on the bone marrow where new blood cells are generated, the combination of these agents is expected to result in complications such as granulocytopenia (very low granulocyte counts). Hematopoietic growth factors such as GM-CSF may reduce the severity and duration of marrow suppression. This may improve survival. Clinical trials of GM-CSF in HIV infected individuals with or without granulocytopenia have shown that the progenitor cells (early blood cells) are responsive to GM-CSF.
Key facts
- Study ID
- NCT00000681
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 24
- Expected to finish
- 1993-10-01
- Last updated by the study team
- 2021-11-03
Who can join
Age: 14 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- USC CRS — Los Angeles, California, United States
- UCLA CARE Center CRS — Los Angeles, California, United States
- Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
- SUNY - Buffalo, Erie County Medical Ctr. — Buffalo, New York, United States
- Pitt CRS — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.