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


Phase 1
14 Years
N/A
Not Enrolling
Both
Sarcoma, Kaposi, HIV Infections

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Trial Information

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


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.

AMENDED 910222 Due to continued concerns about GM-CSF toxicities seen in the 5 mcg/kg GM-CSF
with 20 mg/m2 adriamycin/BV/AZT cohort, the GM-CSF dose in this study has been reduced while
the adriamycin dose escalation will continue.

AMENDED 900430 Dosages for AZT and GM-CSF changed to reflect ongoing results. Original
design: Patients receive the combination of AZT, antineoplastic chemotherapy, and GM-CSF in
groups of three patients each. The first group receives baseline doses, and if the treatment
is well tolerated, the subsequent groups of patients receive higher doses of the
chemotherapy, in which the dose of doxorubicin is increased while bleomycin, vincristine,
and AZT doses remain fixed throughout the study. The dose of all drugs remains fixed for a
given patient. The anticancer drugs are given intravenously every 2 weeks. AZT is given
every 4 hours by mouth. GM-CSF is self-injected subcutaneously every day from day 2 - day 12
of each treatment cycle. Patients repeat the chemotherapy every 2 weeks, for a maximum of
seven cycles, with AZT being given continuously. When the maximum tolerated dose (MTD) of
chemotherapy combined with GM-CSF is determined, the next phase of the study begins. Again
the dose of chemotherapy is increased in groups of patients, but the every-day dose of
GM-CSF is increased. Again, these chemotherapy cycles are repeated every 2 weeks up to a
maximum of seven cycles. Patients receive physician examination and laboratory tests every
week during the study and again at 4 weeks after the study. AMENDED: Dosages for AZT and
GM-CSF have been changed to reflect ongoing results.

Inclusion 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).

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Gill PS

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 094

NCT ID:

NCT00000681

Start Date:

Completion Date:

October 1993

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Vincristine
  • Doxorubicin
  • Drug Evaluation
  • Drug Therapy, Combination
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • Bleomycin
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • Sarcoma

Name

Location

UCLA CARE Center CRSLos Angeles, California  90095
USC CRSLos Angeles, California  90033
Beth Israel Deaconess Med. Ctr., ACTG CRSBoston, Massachusetts  02215
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, New York  14215
Pitt CRSPittsburgh, Pennsylvania  15213