Thalidomide in Treating Patients With HIV-Associated Kaposi's Sarcoma

August 14, 2013 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Medicine Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Robert Yarchoan, MD, National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1996

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

April 12, 2004

First Posted (Estimate)

April 13, 2004

Study Record Updates

Last Update Posted (Estimate)

August 16, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000064453
  • NCI-96-C-0004E
  • NCI-T95-0067N

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcoma

Clinical Trials on thalidomide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe