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A PHASE II STUDY OF ORAL THALIDOMIDE FOR PATIENTS WITH HIV INFECTION AND KAPOSI'S SARCOMA


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

A PHASE II STUDY OF ORAL THALIDOMIDE FOR PATIENTS WITH HIV INFECTION AND KAPOSI'S SARCOMA


OBJECTIVES: I. Determine the antitumor activity of thalidomide in terms of regression or
stabilization of disease in patients with HIV-associated Kaposi's sarcoma. II. Determine the
toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of this
regimen in these patients.

OUTLINE: Patients receive oral thalidomide on day 1. Treatment continues daily for 6 months
in the absence of disease progression or unacceptable toxicity. Patients with complete or
partial response or stable disease after 6 months of treatment may continue treatment for an
additional 6 months. Patients are followed at 1, 6, and 12 months.

PROJECTED ACCRUAL: A total of 15-25 evaluable patients will be accrued for this study within
3.75-6.25 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven Kaposi's sarcoma (KS) HIV-positive by ELISA
and Western blot Disease progression within the past 2 months Evaluable disease by
non-invasive methods Minimum of 5 measurable lesions previously untreated with local
therapy (such as intralesional injections) Ineligible if reduced performance status beyond
minimally symptomatic pulmonary disease or other potentially or acutely life-threatening
KS present Visceral disease, including pulmonary disease, allowed if the following
conditions are met: Not acutely life-threatening No effect on performance status beyond
minimal symptoms No urgent requirement for chemotherapy May be ineligible if actively
bleeding or critically located KS lesions present that pose an immediate risk

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: More than 3 months Hematopoietic: Absolute neutrophil count at least 750/mm3
Platelet count at least 70,000/mm3 Hemoglobin at least 8 g/dL (at least 1 month since
prior transfusion) Hepatic: Bilirubin no greater than 2.0 mg/dL (no greater than 3.8 mg/dL
if elevation due to a protease inhibitor or Gilbert's syndrome) AST and ALT no greater
than 125 U/L PT or APTT no greater than 120% of control No history of hepatic cirrhosis
Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 70 mL/min
Pulmonary: See Disease Characteristics Other: Not pregnant Negative pregnancy test Fertile
patients must use effective hormonal and barrier contraception for at least 1 week before,
during, and for at least 1 month after study No greater than grade 1 peripheral neuropathy
of any etiology except a localized neuropathy due to a mechanical cause or trauma No other
malignancy within the past year except completely resected basal cell skin cancer No grade
3 toxicity except lymphopenia or neutropenia No hypersensitivity to thalidomide or related
compounds No evidence of underlying severe or life-threatening bacterial, viral, fungal,
or protozoal infection within the past 2 weeks Fever of 39 degrees Celsius or greater
within the past 10 days allowed only if not due to a severe underlying infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon No prior thalidomide for
KS At least 6 months since prior suramin Chemotherapy: At least 4 weeks since prior
chemotherapy Endocrine therapy: No prior systemic steroids except physiologic replacement
doses of corticosteroids, sex hormones, or noncorticosteroids such as anabolic steroids
for wasting syndrome Concurrent short-term courses of steroids allowed Radiotherapy: No
prior radiotherapy Surgery: Not specified Other: At least 2 weeks since prior
antiretroviral therapy OR On stable doses of 1 or more of the following for at least 2
weeks before study: Zidovudine, zalcitabine, didanosine, lamivudine, or stavudine Protease
inhibitor Non-nucleoside reverse transcriptase inhibitor No other prior systemic anti-KS
agent or regimen No other concurrent anti-KS therapy during the first 6 months of the
study No concurrent sedating drugs that cannot be reduced to below a minimal level,
sedating recreational drugs, or alcohol No change, initiation, or discontinuation of
antiretroviral therapy unless medically indicated Concurrent intralesional therapy after 6
months on study on rare occasions for occasional painful or disfiguring lesions allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert Yarchoan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000064453

NCT ID:

NCT00019123

Start Date:

April 1996

Completion Date:

Related Keywords:

  • Sarcoma
  • AIDS-related Kaposi sarcoma
  • Sarcoma, Kaposi
  • Sarcoma

Name

Location

Medicine BranchBethesda, Maryland  20892