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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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ClinicalTrials.gov Identifier: NCT00000725
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sarcoma, Kaposi HIV Infections Drug: Interferon alfa-2a Drug: Zidovudine Drug: Interferon alfa-n1 Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 56 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Completion Date : February 1990

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000725


Locations
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Fischl MA
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000725     History of Changes
Other Study ID Numbers: ACTG 013
10989 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Interferon Alfa-2a
Sarcoma, Kaposi
Dose-Response Relationship, Drug
Drug Therapy, Combination
 Acquired Immunodeficiency Syndrome
Zidovudine
Interferon Type I

Additional relevant MeSH terms:
HIV Infections
Sarcoma
Sarcoma, Kaposi
AIDS-Related Opportunistic Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Herpesviridae Infections
DNA Virus Infections
Neoplasms, Vascular Tissue
Opportunistic Infections
Infection
Parasitic Diseases
Interferons
Interferon-alpha
Zidovudine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites