Mode
Text Size
Log in / Sign up
N/A N=6 Treatment

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

Sarcoma

Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Nov 2015
Primary outcome: Primary: Tumor Response Rate Every 4 Weeks — 4; 1 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
valganciclovir (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Memorial Sloan Kettering Cancer Center
Primary completion
Feb 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Tumor Response Rate Every 4 Weeks
4; 1

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00096538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search