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Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma
This study has been completed.
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096538
  Purpose

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.


Condition Intervention
Sarcoma
Drug: valganciclovir

MedlinePlus related topics: Cancer Kaposi's Sarcoma Soft Tissue Sarcoma
Drug Information available for: Valganciclovir Valganciclovir hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response rate every 4 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Human herpesvirus-8 gene expression in tumor biopsies by quantitative real-time polymerase chain reaction at baseline, week 4, and week 16 [ Designated as safety issue: No ]
  • Markers of angiogenesis in tumor biopsies by immunohistochemistry at baseline, week 4, and week 16 [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: April 2004
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096538

Locations
United States, New York
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Susan E. Krown, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000393194, MSKCC-04055
Study First Received: November 9, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00096538  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
classic Kaposi sarcoma
recurrent Kaposi sarcoma

Study placed in the following topic categories:
Virus Diseases
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
Valganciclovir
Malignant mesenchymal tumor
Sarcoma, Kaposi
Sarcoma
Ganciclovir
DNA Virus Infections
Soft tissue sarcomas
Recurrence
Herpesviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms
Neoplasms by Histologic Type
Therapeutic Uses
Neoplasms, Vascular Tissue
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009