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

Primary Purpose

Sarcoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
valganciclovir
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan - Kettering Cancer Center
  • New York Weill Cornell Cancer Center at Cornell University
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

valganciclovir

Arm Description

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.

Outcomes

Primary Outcome Measures

Tumor Response Rate Every 4 Weeks

Secondary Outcome Measures

Full Information

First Posted
November 9, 2004
Last Updated
October 21, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), New York Presbyterian Hospital, Weill Medical College of Cornell University, University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT00096538
Brief Title
Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma
Official Title
Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), New York Presbyterian Hospital, Weill Medical College of Cornell University, University of North Carolina, Chapel Hill

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
valganciclovir
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
valganciclovir
Primary Outcome Measure Information:
Title
Tumor Response Rate Every 4 Weeks
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan E. Krown, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan - Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States

12. IPD Sharing Statement

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

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