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Antiviral Therapy in Treating Patients With Kaposi's Sarcoma With or Without HIV Infection

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cidofovir
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring classic Kaposi sarcoma, AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 3 months Hematopoietic: Absolute neutrophil count at least 750/mm3 Platelet count at least 75,000/mm3 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 normal (unless due to Gilbert's disease) Patients on protease inhibitors may have bilirubin no greater than 3.5 mg/dL (direct bilirubin no greater than 0.2 mg/dL) 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 PRIOR CONCURRENT THERAPY: At least 1 week since treatment with any of the following: Diuretics Vidarabine Amphotericin B Aminoglycoside antibiotics Intravenous pentamidine Other known or potentially nephrotoxic agents Other investigational agents with anti-herpesvirus activity At least 4 weeks since systemic or local anti-herpesvirus therapy other than mucocutaneous acyclovir cream At least 4 weeks 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

Sites / Locations

  • Medicine Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
June 19, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00019240
Brief Title
Antiviral Therapy in Treating Patients With Kaposi's Sarcoma With or Without HIV Infection
Official Title
PHASE II PROTOCOL WITH LABORATORY CORRELATES OF 1-[(S)-3-HYDROXY-2-(PHOSPHOMETHOXY)PROPYL]CYTOSINE DIHYDRATE(CIDOFOVIR) IN PATIENTS WITH KAPOSI'S SARCOMA (KS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
November 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Herpesvirus is found in Kaposi's sarcoma lesions in most patients; it is therefore possible that the herpesvirus has a role in causing Kaposi's sarcoma. Cidofovir is an antiviral drug that acts against many types of herpesvirus, and may be an effective treatment for Kaposi's sarcoma. PURPOSE: Phase II trial to study the effectiveness of cidofovir in treating patients with Kaposi's sarcoma with or without HIV infection.
Detailed Description
OBJECTIVES: I. Assess the antitumor activity of intravenous cidofovir in patients with Kaposi's sarcoma (KS) with and without human immunodeficiency virus (HIV) infection. II. Assess the effect of intravenous cidofovir on the load of KS-associated herpesvirus/human herpesvirus-8 in KS lesions and peripheral blood mononuclear cells by quantitative polymerase chain reaction. III. Assess the toxicity of cidofovir in KS patients with and without HIV infection. IV. Assess the effect of cidofovir on angiogenic cytokines related to the pathogenesis of KS. OUTLINE: 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. PROJECTED ACCRUAL: Up to 25 evaluable patients will be entered over approximately 6 months if there are at least 2 responses in the first 15 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
classic Kaposi sarcoma, AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cidofovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 3 months Hematopoietic: Absolute neutrophil count at least 750/mm3 Platelet count at least 75,000/mm3 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 normal (unless due to Gilbert's disease) Patients on protease inhibitors may have bilirubin no greater than 3.5 mg/dL (direct bilirubin no greater than 0.2 mg/dL) 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 PRIOR CONCURRENT THERAPY: At least 1 week since treatment with any of the following: Diuretics Vidarabine Amphotericin B Aminoglycoside antibiotics Intravenous pentamidine Other known or potentially nephrotoxic agents Other investigational agents with anti-herpesvirus activity At least 4 weeks since systemic or local anti-herpesvirus therapy other than mucocutaneous acyclovir cream At least 4 weeks 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Yarchoan, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Medicine Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9151779
Citation
Kedes DH, Ganem D. Sensitivity of Kaposi's sarcoma-associated herpesvirus replication to antiviral drugs. Implications for potential therapy. J Clin Invest. 1997 May 1;99(9):2082-6. doi: 10.1172/JCI119380.
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Antiviral Therapy in Treating Patients With Kaposi's Sarcoma With or Without HIV Infection

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