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Spots Global Cancer Trial Database for Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma

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Trial Identification

Brief Title: Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma

Official Title: Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma

Study ID: NCT00000660

Interventions

Etoposide

Study Description

Brief Summary: To define the toxicity and maximum-tolerated dose of weekly oral etoposide (VP-16) in patients with AIDS-related Kaposi's sarcoma; to determine the clinical pharmacology of orally administered VP-16 in AIDS patients. A secondary objective is to obtain preliminary data for determining the effect of oral VP-16 on Kaposi's sarcoma. VP-16 is an antitumor agent. Previous problems with VP-16 include the route of administration and the toxicities. VP-16 has been given intravenously for 3 consecutive days in a 21-day cycle for lung cancer and testicular cancer. VP-16 has also been used in lymphoma therapy. Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid the pain, inconvenience, and potential complications associated with medications administered intravenously. The relative ease of outpatient administration and the potentially significant antitumor activity of oral VP-16 motivates this study. The possibility of weekly drug administration is the other focus of this study.

Detailed Description: VP-16 is an antitumor agent. Previous problems with VP-16 include the route of administration and the toxicities. VP-16 has been given intravenously for 3 consecutive days in a 21-day cycle for lung cancer and testicular cancer. VP-16 has also been used in lymphoma therapy. Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid the pain, inconvenience, and potential complications associated with medications administered intravenously. The relative ease of outpatient administration and the potentially significant antitumor activity of oral VP-16 motivates this study. The possibility of weekly drug administration is the other focus of this study. Four patients are entered at each dose level starting with level 1. Patients are not entered into the next higher dose level until at least two patients at the previous dose level have completed at least 3 weeks of therapy with grade 2 or less maximum tolerated dose-defining toxicities. Treatment is repeated weekly for 52 weeks until either a grade 3 or 4 toxicity occurs, or until a patient shows a complete response or progressive disease. Patients with a complete response are continued on drug for 4 additional weeks from the time that complete response is first documented. Patients with progressive disease are withdrawn from study. Patients with partial response or stable disease continue until either unacceptable toxicity occurs or a complete response or progression of disease is reached.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

San Francisco Gen Hosp, San Francisco, California, United States

Bellevue Hosp / New York Univ Med Ctr, New York, New York, United States

Mem Sloan - Kettering Cancer Ctr, New York, New York, United States

Saint Luke's - Roosevelt Hosp Ctr, New York, New York, United States

Univ of Rochester Medical Center, Rochester, New York, United States

Julio Arroyo, West Columbia, South Carolina, United States

Contact Details

Name: J Kahn

Affiliation:

Role: STUDY_CHAIR

Name: S Krown

Affiliation:

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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