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Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Interferon beta-1b
Zidovudine
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 Drug Evaluation, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, Interferon Type I

Eligibility Criteria

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

Inclusion Criteria Concurrent Treatment: Allowed: Local radiotherapy or laser therapy to cosmetically apparent Kaposi's lesions, provided the dose to any one lesion does not exceed 3000 gray and the total surface area of all lesions treated does not exceed 10 cm2 during the course of the trial. Patients must demonstrate the following clinical and laboratory findings: Positive for HIV by federally licensed ELISA test. Acceptable bone marrow function. Acceptable renal function. Acceptable hepatic function. Exclusion Criteria Concurrent Medication: Excluded: Other potentially antiretroviral compounds. Patients will be excluded from the study for the following reasons: Concurrent, active opportunistic infections requiring therapy. Extensive Kaposi's sarcoma with more than 100 cutaneous lesions, requiring systemic chemotherapy, prior treatment with more than one chemotherapy regimen, excluding intralesional therapy, or symptomatic visceral Kaposi's sarcoma. Evidence of clinically significant cardiac dysfunction (New York Heart Association grade III or IV). History of malignant neoplasms other than nonmelanomatous skin cancer or cancer in situ of the cervix. Proteinuria of 2+ or greater and/or 24-hour urine protein of greater than 1. Prior Medication: Excluded: More than one chemotherapy regimen for Kaposi's sarcoma. Any interferon preparation or zidovudine (AZT). Excluded within 30 days of study entry: Other immunomodifiers. Acyclovir. Other investigational drugs. Excluded within 60 days of study entry: Cytotoxic therapy. Patients may not have any of the following diseases or symptoms: Development of an AIDS-defining opportunistic infection, other than oral thrush or localized zoster. Non-Kaposi's sarcoma, AIDS-defining malignancy.

Sites / Locations

  • Los Angeles County - USC Med Ctr
  • USC School of Medicine / Norris Cancer Hosp
  • UCLA CARE Ctr
  • Northwestern Univ Med School

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 26, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000695
Brief Title
Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma
Official Title
Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related 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
July 1991 (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 determine the highest tolerated dose of the safety and tolerance of interferon beta (IFN-B) when it is given at the same time as zidovudine (AZT) to patients with early AIDS related Kaposi's sarcoma. In addition, the studies will determine preliminary data on response, immune function, and subcutaneous absorption. IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants.
Detailed Description
IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants. Patients undergo evaluations to determine the extent of their disease and the status of their immune system. Patients then receive IFN-B subcutaneously once a day at one of three different dose levels. Patients also take AZT at 1 of 2 doses. The first 12 patients are treated with the lower dose of AZT. The first 4 patients are entered at level 1 of IFN-B. If no dose-limiting toxicity is seen in these 4 patients after 2 weeks of therapy, 4 patients are then enrolled at level 2 of IFN-B. The study proceeds in this manner until the highest tolerated dose or level 3 is reached. If both drugs are tolerated, patients then remain on both medications as long as they continue to tolerate the medications and show some improvement in either antiviral response, immune response, or clinical response for as long as 24 weeks. The initial three doses of IFN-B are given to each patient at the study site during which time the patient is trained to self-administer the IFN-B. Patients are then seen weekly for 4 months and every 2 weeks thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Drug Evaluation, 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
36 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interferon beta-1b
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Treatment: Allowed: Local radiotherapy or laser therapy to cosmetically apparent Kaposi's lesions, provided the dose to any one lesion does not exceed 3000 gray and the total surface area of all lesions treated does not exceed 10 cm2 during the course of the trial. Patients must demonstrate the following clinical and laboratory findings: Positive for HIV by federally licensed ELISA test. Acceptable bone marrow function. Acceptable renal function. Acceptable hepatic function. Exclusion Criteria Concurrent Medication: Excluded: Other potentially antiretroviral compounds. Patients will be excluded from the study for the following reasons: Concurrent, active opportunistic infections requiring therapy. Extensive Kaposi's sarcoma with more than 100 cutaneous lesions, requiring systemic chemotherapy, prior treatment with more than one chemotherapy regimen, excluding intralesional therapy, or symptomatic visceral Kaposi's sarcoma. Evidence of clinically significant cardiac dysfunction (New York Heart Association grade III or IV). History of malignant neoplasms other than nonmelanomatous skin cancer or cancer in situ of the cervix. Proteinuria of 2+ or greater and/or 24-hour urine protein of greater than 1. Prior Medication: Excluded: More than one chemotherapy regimen for Kaposi's sarcoma. Any interferon preparation or zidovudine (AZT). Excluded within 30 days of study entry: Other immunomodifiers. Acyclovir. Other investigational drugs. Excluded within 60 days of study entry: Cytotoxic therapy. Patients may not have any of the following diseases or symptoms: Development of an AIDS-defining opportunistic infection, other than oral thrush or localized zoster. Non-Kaposi's sarcoma, AIDS-defining malignancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Miles
Official's Role
Study Chair
Facility Information:
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC School of Medicine / Norris Cancer Hosp
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Stavermann T, Bauer G, Ruess A. Recombinant interferon-beta in the therapy of advanced AIDS-related Kaposi's sarcoma. Int Conf AIDS. 1993 Jun 6-11;9(1):402 (abstract no PO-B12-1600)
Results Reference
background
PubMed Identifier
9557213
Citation
Miles S, Levine A, Feldstein M, Carden J, Cabriallas S, Marcus S, Mitsuyasu R, Gill P. Open-label phase I study of combination therapy with zidovudine and interferon-beta in patients with AIDS-related Kaposi's sarcoma: AIDS Clinical Trials Group Protocol 057. Cytokines Cell Mol Ther. 1998 Mar;4(1):17-23.
Results Reference
background

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Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma

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