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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Page 1 of 2 (5 locations)

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