Search / Trial NCT00000681

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 09, 2024

Completed

Keywords

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

ClinConnect Summary

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 gra...

Gender

ALL

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).

Trial Officials

Gill PS

Study Chair

Miles S

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Los Angeles, California, United States

Los Angeles, California, United States

Boston, Massachusetts, United States

Buffalo, New York, United States

Pittsburgh, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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