A Study of AZT Plus Human Interferon Alpha in the Treatment of AIDS-Related Kaposi's Sarcoma
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|ClinicalTrials.gov Identifier: NCT00001113|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : March 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma, Kaposi HIV Infections||Drug: Interferon alfa-2a Drug: Zidovudine Drug: Interferon alfa-n1||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Masking:||None (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|
|Study Completion Date :||March 1990|
U.S. FDA Resources
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): NCT00001113
|United States, New York|
|Mem Sloan - Kettering Cancer Ctr|
|New York, New York, United States, 10021|
|Study Chair:||Krown S|