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

NCT00096538 | Completed Results

• 2 other identifiers: 04-055MSKCC-04055
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

Sarcoma

Keywords

classic Kaposi sarcoma; recurrent Kaposi sarcoma

Outcome Measures

Primary Outcomes (1)

• Tumor Response Rate Every 4 Weeks

  2 years

Study Arms (1)

valganciclovir

EXPERIMENTAL

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

Interventions

valganciclovir DRUG

valganciclovir

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• New York Presbyterian Hospital: collaborator
• Weill Medical College of Cornell University: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (3)

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

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

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

Sarcoma; Sarcoma, Kaposi

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Ariela Noy
• Organization: Memorial Sloan Kettering Cancer Center

noya@mskcc.org

212-639-7423

Study Officials

• Susan E. Krown, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 10, 2004
• Study Start: April 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: November 25, 2015
• Results First Posted: November 25, 2015

Record last verified: 2015-10

Locations

US (3)