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Thalidomide in Treating Patients With HIV-Associated Kaposi's Sarcoma
This study has been completed.
First Received: July 11, 2001   Last Updated: December 13, 2008   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019123
  Purpose

RATIONALE: Thalidomide may kill cancer cells by stopping the growth of new blood vessels to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients with HIV-associated Kaposi's sarcoma.


Condition Intervention Phase
Sarcoma
Drug: thalidomide
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A PHASE II STUDY OF ORAL THALIDOMIDE FOR PATIENTS WITH HIV INFECTION AND KAPOSI'S SARCOMA

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 1996
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019123

Locations
United States, Maryland
Medicine Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Study Chair: Robert Yarchoan, MD National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000064453, NCI-96-C-0004E, NCI-T95-0067N
Study First Received: July 11, 2001
Last Updated: December 13, 2008
ClinicalTrials.gov Identifier: NCT00019123     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
AIDS-related Kaposi sarcoma

Study placed in the following topic categories:
Immunologic Factors
Thalidomide
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Angiogenesis Inhibitors
Immunosuppressive Agents
Herpesviridae Infections
Kaposi Sarcoma
Virus Diseases
Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Malignant Mesenchymal Tumor
Soft Tissue Sarcomas
HIV Infections
Sarcoma
DNA Virus Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Thalidomide
Immunologic Factors
Antineoplastic Agents
Growth Substances
Sarcoma, Kaposi
Physiological Effects of Drugs
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Herpesviridae Infections
Virus Diseases
Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Neoplasms
Therapeutic Uses
Sarcoma
Neoplasms, Vascular Tissue
DNA Virus Infections
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on July 02, 2009