A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma

NCT00000681 | Completed Phase 1

• 2 other identifiers: ACTG 09411069
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Sarcoma, Kaposi; HIV Infections

Keywords

Vincristine; Doxorubicin; Drug Evaluation; Drug Therapy, Combination; Granulocyte-Macrophage Colony-Stimulating Factor; Acquired Immunodeficiency Syndrome; Zidovudine; Bleomycin

Interventions

Bleomycin sulfate DRUG

Vincristine sulfate DRUG

Doxorubicin hydrochloride DRUG

Zidovudine DRUG

Sargramostim DRUG

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (5)

USC CRS

Los Angeles, California, 900331079, United States

Location

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02215, United States

Location

SUNY - Buffalo, Erie County Medical Ctr.

Buffalo, New York, 14215, United States

Location

Pitt CRS

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Gill PS, Bernstein-Singer M, Espina BM, Rarick M, Magy F, Montgomery T, Berry MS, Levine A. Adriamycin, bleomycin and vincristine chemotherapy with recombinant granulocyte-macrophage colony-stimulating factor in the treatment of AIDS-related Kaposi's sarcoma. AIDS. 1992 Dec;6(12):1477-81. doi: 10.1097/00002030-199212000-00009.

  PMID: 1283520 BACKGROUND

MeSH Terms

Conditions

Sarcoma, Kaposi; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Bleomycin; Vincristine; Doxorubicin; Zidovudine; sargramostim

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Gill PS

  STUDY CHAIR

• Miles S

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: October 1, 1993
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (5)