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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Mem Sloan - Kettering Cancer Ctr

New York, New York, United States, 10021

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 | DecenTrialz