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Clinical Trials (PDQ®)

Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, TreatmentCompleted18 and overNCI, Other04-055
MSKCC-04055, NCT00096538

Trial Description

Summary

RATIONALE: Herpesvirus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Valganciclovir is an antiviral drug that acts against many types of herpesviruses and may be an effective treatment for Kaposi's sarcoma.

PURPOSE: This clinical trial is studying how well valganciclovir works in treating patients with classic non-HIV-associated Kaposi's sarcoma.

Further Study Information

OBJECTIVES:

Primary

  • Determine the antitumor activity of valganciclovir in patients with classic non-HIV-associated Kaposi's sarcoma (KS).

Secondary

  • Determine the effect of this drug on lytic and latent human herpesvirus-8 gene expression in KS lesions of these patients.
  • Determine the effect of this drug on the markers of angiogenesis in KS lesions of these patients.
  • Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is a pilot study.

Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity.

All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 1 year.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed classic Kaposi's sarcoma (KS) involving the skin
  • Non-HIV-associated disease
  • HIV negative
  • Measurable disease
  • At least 8 KS lesions with ≥ 5 marker lesions measurable in 2 dimensions AND ≥ 3 other lesions measuring ≥ 1 cm in diameter
  • Two 3 mm punch biopsies of a non-marker lesion entirely composed of KS
  • Irradiated cutaneous lesions may not be used as indicator lesions
  • No known active visceral KS or symptomatic KS-related edema that would preclude function or require cytotoxic chemotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • At least 12 months

Hematopoietic

  • Hemoglobin ≥ 8 g/dL
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN

Renal

  • Creatinine clearance ≥ 50 mL/min

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • No hypersensitivity to valganciclovir or ganciclovir
  • No other neoplasia requiring cytotoxic therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior biological therapy for KS
  • No concurrent immunotherapy

Chemotherapy

  • More than 4 weeks since prior chemotherapy for KS
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent corticosteroid treatment except for replacement doses (equivalent to 20 mg of hydrocortisone per day)

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy for KS
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • More than 14 days since prior acute treatment for infection (other than oral thrush or genital herpes) or other serious medical illness
  • More than 60 days since prior local therapy for any KS indicator lesion unless the lesion showed documented progression since treatment
  • More than 4 weeks since prior local therapy for KS
  • More than 4 weeks since prior investigational agents
  • More than 4 weeks since other prior antineoplastic therapy for KS
  • No other concurrent antiviral therapy
  • No other concurrent investigational agents
  • No other concurrent systemic therapy for KS

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

National Cancer Institute

New York Weill Cornell Cancer Center at Cornell University

New York Weill Cornell Cancer Center at Cornell University

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Susan E. KrownStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00096538
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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