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Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS) Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS) Clinical research trials and Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS) medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS). Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS) Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS) clinical trial. Participants frequently get the best healthcare available for their Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS) condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS)  Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS)
Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS)
For Condition: Acquired Immunodeficiency Syndrome,HIV Infection,Herpesviridae Infection,Kaposi's Sarcoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: All patients receive intravenous cidofovir weekly for 2 weeks, then every other week for 6 months. Patients with a complete or partial response may continue treatment until disease progression intervenes.
Details: Goals: 1) Assessment of the activity of intravenous cidofovir in the treatment of patients with Kaposi's sarcoma (KS) with and without HIV infection. 2) Assessment of the effect of intravenous cidofovir on the load of KSHV/HHV-8 in KS lesions and peripheral blood mononuclear cells (PBMCs) by quantitative PCR. 3) Assessment of the toxicity of cidofovir in KS patients with and without HIV infection. 4) Assessment of the effects of cidofovir on angiogenic cytokines related to the pathogenesis of KS. Design: Open-label, non-randomized phase II study. Regimen: Intravenous cidofovir, 5 mg/kg once weekly for two weeks (induction), then 5 mg/kg once every other week (maintenance). Population: Patients greater than or equal to 18 years with KS, with or without HIV infection. Eligible patients may have received any number of previous chemotherapy regimens or limited courses of acyclovir for mucocutaneous herpesvirus infections, but may not have received anti-herpesvirus therapy within 6 months of study entry. Patients with substantially symptomatic pulmonary or other acutely life-threatening KS will be ineligible. Endpoints: Response of KS lesions; viral load of KSHV/HHV-8 in KS lesions; viral load of KSHV/HHV-8 in PBMC.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Biopsy-proven Kaposi's sarcoma (KS). HIV infection (measured by ELISA and Western blot) allowed. NCI pathology review required. At least 5 measurable lesions required. No prior local therapy to indicator lesions. Lesions evaluable by noninvasive methods. No actively bleeding or critically located KS of immediate risk to patient or at the discretion of the Principal Investigator and/or Study Chairperson. No pulmonary or other potentially acutely life-threatening KS lesions. PRIOR/CONCURRENT THERAPY: At least 1 week since treatment with any of the following: Diuretics, Vidarabine, Amphotericin B, Aminoglycoside antibiotics, Intravenous pentamidin, Other known or potentially nephrotoxic agents, Other investigational agents with anti-herpes virus activity. At least 4 weeks since systemic or local anti-herpes virus therapy other than mucocutaneous acyclovir cream. At least 3 months since systemic therapy for KS or other systemic or cutaneous malignancy. At least 1 month since discontinuation of antiretroviral therapy. Concurrent antiretroviral therapy allowed provided doses of the following, either alone or in combination, stable for at least 1 month prior to entry: AZT, ddC, 3TC, ddI, d4T, protease inhibitor. PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: Karnofsky 70%-100%. Life expectancy: More than 3 months. HEMATOPOIETIC: ANC at least 750. Platelets at least 75,000. Hemoglobin at least 11 g/dL (10 g/dL in women). CD4 count greater than 50 cells per cubic millimeter. HEPATIC: Bilirubin no greater than 1.5 times ULN (unless due to Gilbert's disease). AST/ALT no greater than 75 IU/mL. Alkaline phosphatase no greater than 2.5 times normal. RENAL: Creatinine less than 1.5 mg/dL. Creatinine clearance (calculated) greater than 55 mL/min Proteinuria less than 2+. Cardiovascular: No significant EKG abnormality. OTHER: No actively life-threatening infection At least 14 days since treatment for serious infection. No known clinically significant allergy to probenecid or sulfa. No grade 3 or worse clinical or laboratory toxicity other than lymphopenia. No medical condition that precludes protocol treatment or informed consent. No second malignancy within 1 year except basal cell skin cancer. No pregnant or nursing women. Negative pregnancy test required of fertile women within 1 week prior to entry, every 4 weeks while on study, and 4 weeks after last treatment. Effective contraception required of fertile women.
Total Enrollment: 32
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970024; 97-C-0024
Study Start Date: November 18, 1996
Record last reviewed: September 7, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001559
Other Acquired Immunodeficiency Syndrome Studies:
1. Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS)
2. A Phase II Study of Oral Thalidomide for Patients with HIV Infection and Kaposi's Sarcoma
3. Assessment of Blood Vessel Density in Kaposi's Sarcoma Lesions
4. Combination Chemotherapy Plus Amifostine in Treating Patients With Metastatic or Unresectable Cancer
5. Specimen Collections from Patients with HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
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Other Acquired Immunodeficiency Syndrome Clinical Trials
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Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS)
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