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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: | NCT00001113 |
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 AZT and IFN-A or AZT and IFN-A2A when given in combination. To define the maximum tolerated dose (MTD) of each drug in combination and to define doses to be used in Phase II trial. 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.
Condition | Intervention | Phase |
---|---|---|
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: | 48 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Co-existing Condition:
Patients with the following complications are excluded:
Patients with the following complications are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded within 30 days of study entry:
Study ID Numbers: | ACTG 014 |
Study First Received: | November 2, 1999 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00001113 |
Health Authority: | United States: Federal Government |
Interferon Alfa-2a Sarcoma, Kaposi Dose-Response Relationship, Drug Drug Evaluation |
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 |