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A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Interferon alfa-2a
Zidovudine
Interferon alfa-n1
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Interferon Alfa-2a, Sarcoma, Kaposi, Dose-Response Relationship, Drug, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, Interferon Type I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients must have biopsy-proven AIDS-associated Kaposi's sarcoma. Evidence of HIV infection as manifested by a positive antibody test. Exclusion Criteria Active drug or alcohol abuse. Co-existing Condition: Excluded are patients with: Active opportunistic infections requiring ongoing therapy. Excluded within 90 days of study entry: Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered. Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia. Concurrent neoplasms other than basal cell carcinoma of the skin. Known hypersensitivity to polymycin B or neomycin. Excluded are patients with: Active opportunistic infections requiring ongoing therapy. Excluded within 90 days of study entry: Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered. Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia. Concurrent neoplasms other than basal cell carcinoma of the skin. Known hypersensitivity to polymycin B or neomycin. Prior Medication: Excluded: Interferon. Zidovudine (AZT). Excluded within 30 days of study entry: Any biologic modifiers, corticosteroids, cytotoxic chemotherapeutic agents. Other drugs which can cause neutropenia or significant nephrotoxicity. Rifampin or rifampin derivatives, or systemic anti-infectives. Excluded within 90 days of study entry: Other antiviral agents. A history of Pneumocystis carinii pneumonia (PCP) completed treatment. Prior Treatment: Excluded within 30 days of study entry: Radiation therapy.

Sites / Locations

  • Univ of Miami School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000725
Brief Title
A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
Official Title
A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1990 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon alpha (IFN-A) and interferon alpha-2A (recombinant) (IFN-A2A). To define the pharmacokinetics of both AZT and IFN-A or IFN-A2A when given in combination; to define the maximum tolerated dose of each drug in combination and to define doses to be used in Phase II trials. AZT has been found to inhibit both the in vitro (in test tube) and cell killing effects of HIV, and both interferons (IFN-A and IFN-A2A) have shown antiviral and antitumor effect in Kaposi's sarcoma. It is reasonable to assume that a synergistic effect and enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and efficacy of AZT in combination with IFN-A or IFN-A2A is warranted.
Detailed Description
AZT has been found to inhibit both the in vitro (in test tube) and cell killing effects of HIV, and both interferons (IFN-A and IFN-A2A) have shown antiviral and antitumor effect in Kaposi's sarcoma. It is reasonable to assume that a synergistic effect and enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and efficacy of AZT in combination with IFN-A or IFN-A2A is warranted. Patients are randomized to receive IFN-A or IFN-A2A (given by intramuscular injection) and combined with AZT (taken orally) daily for 8 weeks. Study stops when maximum tolerated dose (MTD) is reached. 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 will escalate only if there is no unacceptable toxicity (grade 2 in = or > 3 patients or > grade 2 in any patient), subsequent increases 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 2 toxicity (grade 3 for hemoglobin, neutrophil count, or SGOT) in 4 of the 6 patients. Patients have blood drawn every week and their general health is evaluated. Pharmacokinetic studies will be done on days 1, 21, and 24. Patients tolerating the combination may be continued on the same dose level for 1 year except if patient has reached complete remission for = or > 90 days, IFN-A or IFN-A2A will decrease to 3 times a week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Interferon Alfa-2a, Sarcoma, Kaposi, Dose-Response Relationship, Drug, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, Interferon Type I

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
56 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interferon alfa-2a
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Interferon alfa-n1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have biopsy-proven AIDS-associated Kaposi's sarcoma. Evidence of HIV infection as manifested by a positive antibody test. Exclusion Criteria Active drug or alcohol abuse. Co-existing Condition: Excluded are patients with: Active opportunistic infections requiring ongoing therapy. Excluded within 90 days of study entry: Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered. Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia. Concurrent neoplasms other than basal cell carcinoma of the skin. Known hypersensitivity to polymycin B or neomycin. Excluded are patients with: Active opportunistic infections requiring ongoing therapy. Excluded within 90 days of study entry: Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered. Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia. Concurrent neoplasms other than basal cell carcinoma of the skin. Known hypersensitivity to polymycin B or neomycin. Prior Medication: Excluded: Interferon. Zidovudine (AZT). Excluded within 30 days of study entry: Any biologic modifiers, corticosteroids, cytotoxic chemotherapeutic agents. Other drugs which can cause neutropenia or significant nephrotoxicity. Rifampin or rifampin derivatives, or systemic anti-infectives. Excluded within 90 days of study entry: Other antiviral agents. A history of Pneumocystis carinii pneumonia (PCP) completed treatment. Prior Treatment: Excluded within 30 days of study entry: Radiation therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fischl MA
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1670585
Citation
Fischl MA, Uttamchandani RB, Resnick L, Agarwal R, Fletcher MA, Patrone-Reese J, Dearmas L, Chidekel J, McCann M, Myers M. A phase I study of recombinant human interferon-alpha 2a or human lymphoblastoid interferon-alpha n1 and concomitant zidovudine in patients with AIDS-related Kaposi's sarcoma. J Acquir Immune Defic Syndr (1988). 1991;4(1):1-10.
Results Reference
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A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma

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