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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00096538
Recruitment Status : Completed
First Posted : November 10, 2004
Results First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
New York Presbyterian Hospital
Weill Medical College of Cornell University
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Sarcoma Drug: valganciclovir Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma
Study Start Date : April 2004
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: valganciclovir
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.
 Drug: valganciclovir


Outcome Measures
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Primary Outcome Measures :
  1. Tumor Response Rate Every 4 Weeks [ Time Frame: 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096538


Locations
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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
National Cancer Institute (NCI)
New York Presbyterian Hospital
Weill Medical College of Cornell University
University of North Carolina, Chapel Hill
Investigators
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Study Chair: Susan E. Krown, MD Memorial Sloan Kettering Cancer Center
More Information
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00096538    
Other Study ID Numbers: 04-055
MSKCC-04055
First Posted: November 10, 2004    Key Record Dates
Results First Posted: November 25, 2015
Last Update Posted: November 25, 2015
Last Verified: October 2015
Keywords provided by Memorial Sloan Kettering Cancer Center:
classic Kaposi sarcoma
recurrent Kaposi sarcoma
Additional relevant MeSH terms:
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Sarcoma, Kaposi
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Herpesviridae Infections
DNA Virus Infections
 Virus Diseases
Infections
Neoplasms, Vascular Tissue
Valganciclovir
Antiviral Agents
Anti-Infective Agents