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Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma


N/A
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate every 4 weeks

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Susan E. Krown, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

04-055

NCT ID:

NCT00096538

Start Date:

April 2004

Completion Date:

February 2008

Related Keywords:

  • Sarcoma
  • classic Kaposi sarcoma
  • recurrent Kaposi sarcoma
  • Sarcoma, Kaposi
  • Sarcoma

Name

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Memorial Sloan - Kettering Cancer CenterNew York, New York  10021