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Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma Clinical research trials and Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma. Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma clinical trial. Subjects typically recieve the finest healthcare available for their Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma  Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma
Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: AMENDED: - 04-21-91 Zidovudine (AZT) allowed after completing 8 weeks on the study. Patients on reduced doses of VP-16 must have tolerated at least 4 consecutive weeks at the reduced dose before starting AZT. Zidovudine will not be provided by the NIAID Clinical Product Research Repository. AMENDED: - Zidovudine (AZT) allowed after completing 12 weeks on study. Allowed: - Aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis (PCP). Concurrent Treatment: Allowed: - Local radiotherapy or laser therapy to cosmetically apparent, non-indicator lesions provided the dose to any one lesion does not exceed 300 rads and the total surface area of all lesions treated does not exceed 10 cm2. Risk Behavior: Allowed: - All risk groups. Patients must: - Have AIDS-related Kaposi's sarcoma. - Be ineligible for protocols of higher priority at study center. - Be willing to sign an informed consent or have guardian willing to sign. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Active opportunistic infection not specifically allowed. - Concurrent neoplasm not specifically allowed. - Significant neurologic, cardiac, or liver disease. Concurrent Medication: Excluded: - Therapy with potentially myelosuppressive, hepatotoxic, or nephrotoxic drugs for an opportunistic infection. Patients with the following are excluded: - Active opportunistic infection not specifically allowed. - Ongoing therapy, including maintenance therapy, for an opportunistic infection with potentially myelosuppressive, hepatotoxic, or nephrotoxic drugs. - Concurrent neoplasm not specifically allowed. - Significant neurologic, cardiac, or liver disease. Prior Medication: Excluded: - Biologic response modifiers or corticosteroids within 14 days prior to study entry. - Cytotoxic chemotherapy within 30 days prior to study entry. - Ribavirin within 6 weeks prior to study entry. - Azidothymidine (AZT), alpha-interferon, didanosine (ddI), ganciclovir (DHPG), or any other antiretroviral drugs within 1 week prior to study entry. Prior Treatment: Excluded within 30 days prior to study entry: - Radiation therapy with > 4000 rads. - Total skin electron beam therapy.
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
JKahn, Study Chair,
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: ACTG 110;
Study Start Date:
Record last reviewed: August 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000660
Other Sarcoma, Kaposi Studies:
1. Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage
2. A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole
3. The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
4. A Phase I/II Dose Escalation Study of Intradermal gp160 to Evaluate Safety, Delayed Type Hypersensitivity (Skin Test) Responses and Immunogenicity in Asymptomatic HIV Seropositive Patients With More Than 400 CD4+ Cells
5. Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir
Related Studies:
Other Sarcoma, Kaposi Clinical Trials
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Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma
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