Sarcoma
Conditions
Keywords
classic Kaposi sarcoma, recurrent Kaposi sarcoma
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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Response Rate Every 4 Weeks | 2 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Valganciclovir |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 6 |
| serious Total, serious adverse events | 1 / 6 |
Outcome results
Tumor Response Rate Every 4 Weeks
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Valganciclovir | Tumor Response Rate Every 4 Weeks | Progression of Disease | 4 participants |
| Valganciclovir | Tumor Response Rate Every 4 Weeks | Stable Disease | 1 participants |