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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000725 |
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 | Intervention | Phase |
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Sarcoma, Kaposi HIV Infections |
Drug: Interferon alfa-2a Drug: Zidovudine Drug: Interferon alfa-n1 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 56 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Co-existing Condition:
Excluded are patients with:
Excluded are patients with:
Prior Medication:
Excluded:
Prior Treatment:
Excluded within 30 days of study entry:
Study ID Numbers: | ACTG 013 |
Study First Received: | November 2, 1999 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00000725 |
Health Authority: | United States: Federal Government |
Interferon Alfa-2a Sarcoma, Kaposi Dose-Response Relationship, Drug Drug Therapy, Combination |
Acquired Immunodeficiency Syndrome Zidovudine Interferon Type I |
Interferon-alpha Interferon Type I, Recombinant Sexually Transmitted Diseases, Viral Malignant mesenchymal tumor Interferons Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Zidovudine Soft tissue sarcomas Immunologic Deficiency Syndromes |
Herpesviridae Infections Virus Diseases Neoplasms, Connective and Soft Tissue Kaposi sarcoma HIV Infections Sexually Transmitted Diseases Sarcoma DNA Virus Infections Interferon Alfa-2a Retroviridae Infections |
Antimetabolites Anti-Infective Agents Slow Virus Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Neoplasms, Vascular Tissue Angiogenesis Modulating Agents |
Growth Inhibitors Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Neoplasms by Histologic Type Immune System Diseases Growth Substances Enzyme Inhibitors Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Lentivirus Infections |