A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
18 Years
N/A
Both
Sarcoma, Kaposi, HIV Infections
Trial Information
A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
AZT has been found to be effective against the effects of HIV in vitro (test tube) and both
interferons have shown antiviral and antitumor effect on Kaposi's sarcoma. It is reasonable
to assume that a synergism and an enhanced antitumor response may be seen with combination
therapy. A study to evaluate the safety and effectiveness of AZT in the combination with
IFN-A2A is warranted.
Patients are randomized to receive IFN-A or IFN-A2A by intramuscular injection and combined
with AZT orally daily for 8 weeks. Two cohorts of 4 patients enter each dose level. Patients
do not enter into the next dose level until all patients have completed 3 weeks of
treatment. AZT escalates only if there is no unacceptable toxicity (grade 2 in = or > 3
patients or > grade 2 in any patients); subsequent increase in IFN-A or IFN-A2A will be
permitted, but the AZT dose will remain fixed. The MTD for a given IFN-A or IFN-A2A dose
level is defined as grade 3 toxicity for hemoglobin or grade 2 toxicity for other parameters
in 3 of the 6 patients. Once the MTD is reached, there will be no further enrollment at
higher dose level. Patients are followed every week for vital signs and hematologic studies.
Patients tolerating the combination may be continued on therapy for 1 year at the same dose
as the end of 8th week.
Inclusion Criteria
Inclusion Criteria
- Patient must have a histologically confirmed diagnosis of Kaposi's sarcoma.
- Positive antibody to HIV confirmed by ELISA or Western blot on the same serum.
Exclusion Criteria
- Active drug or alcohol abuse.
Co-existing Condition:
Patients with the following complications are excluded:
- Active opportunistic infections requiring ongoing therapy.
- Pneumocystis carinii pneumonia (PCP) unless recovered must be off therapy within 90
days prior to study.
- Clinically significant cardiac disease, including a history of myocardial infarction
or arrhythmia.
- Concurrent neoplasms other than basal cell carcinoma of skin.
- Known sensitivity to polymycin or neomycin.
Patients with the following complications are excluded:
- Active opportunistic infections requiring ongoing therapy.
- Pneumocystis carinii pneumonia (PCP) unless recovered must be off therapy within 90
days prior to study.
- Clinically significant cardiac disease, including a history of myocardial infarction
or arrhythmia.
- Concurrent neoplasms other than basal cell carcinoma of skin.
- Known sensitivity to polymycin or neomycin.
Prior Medication:
Excluded:
- Any prior zidovudine (AZT) or interferon alpha protocol participation.
- Excluded within 30 days of study entry:
- Immunomodulating agents.
- Other drugs that can cause neutropenia or significant nephrotoxicity, or systemic
anti-infectives.
- Excluded within 90 days of study entry:
- Antiretroviral agents.
- Treatment of Pneumocystis carinii pneumonia (PCP).
Prior Treatment:
Excluded within 30 days of study entry:
- Radiation therapy.
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Krown S
Investigator Role:
Study Chair
Authority:
United States: Federal Government
Study ID:
ACTG 014
NCT ID:
NCT00001113
Start Date:
Completion Date:
March 1990
Related Keywords:
- Sarcoma, Kaposi
- HIV Infections
- Interferon Alfa-2a
- Sarcoma, Kaposi
- Dose-Response Relationship, Drug
- Drug Evaluation
- Drug Therapy, Combination
- Acquired Immunodeficiency Syndrome
- Zidovudine
- Interferon Type I
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Sarcoma, Kaposi
- Sarcoma
Name | Location |
|---|---|
| Mem Sloan - Kettering Cancer Ctr | New York, New York 10021 |
