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Home > "A" Clinical Trials Conditions > A Phase II Study of Oral Thalidomide for Patients with HIV Infection and Kaposi's Sarcoma  A Phase II Study of Oral Thalidomide for Patients with HIV Infection and Kaposi's Sarcoma
A Phase II Study of Oral Thalidomide for Patients with HIV Infection and Kaposi's Sarcoma
For Condition: HIV Infection,Kaposi's Sarcoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Thalidomide is a potent inhibitor of angiogenesis in animal models. This is a phase II/III trial to investigate whether oral thalidomide will be effective in the treatment of HIV-associated Kaposi's sarcoma (KS). Patients will receive the drug (at doses of up to 1000 mg/day if tolerated) for six months. The treatment period may be extended to one year in patients who appear to derive benefit against their KS. There is evidence that thalidomide has other activity in HIV-infected patients: there is evidence that it may be useful for the treatment of HIV-associated wasting syndrome (due to thalidomide-mediated inhibition of TNF-alpha) and it has activity in the therapy of HIV-related aphthous stomatitis. Thalidomide appears to have immunomodulatory (but not immunosuppressive) effects and has been shown to inhibit HIV replication in vitro. In order to enroll in the study, patients must be off anti-KS therapy for 4 weeks and be on a stable antiretroviral regimen (or be off antiretroviral therapy) for a minimum of two weeks prior to beginning the trial. Women of child-bearing age are not excluded, but are required to have a negative pregnancy test and agree to use both barrier (condom) and hormonal methods of contraception during the study. Note that pregnancy testing will be performed frequently in this group of patients. (This trial will be conducted at the NIH Clinical Center in Bethesda, MD. Most travel costs and a housing stipend will be provided to patients while on the protocol. However, patients will have to pay for their initial trip to the Clinical Center.) For more information, contact Kathy Wyvill, R.N. or Tino Merced-Galindez, R.N. at (301) 496-8959 or Dr. Richard Little at (800) 772-5464 ext 657.
Details: Neovascularization and angiogenesis are important in the pathogenesis of Kaposi's sarcoma (KS). Thalidomide is a drug that has activity in some diseases which involve immune dysfunction. It has also been shown to inhibit angiogenesis. This is a phase II study of oral thalidomide for HIV-related KS. Goals are to determine activity/response rate and to identify the toxicity profile in HIV-seropositive patients with KS. In addition, information will be obtained about the effects of thalidomide on HIV replication, as well as its effects on certain cytokines and angiogenesis factors. Fifteen patients will be treated initially; if 2 or more have objective responses, an additional ten patients will be treated. Pregnant women and women of child-bearing age who do not agree to use both hormonal and barrier methods of contraception will be excluded. Patients with pulmonary or other potentially acutely life-threatening KS will also be excluded.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Biopsy-proven Kaposi's sarcoma (KS) in HIV-positive patients (by ELISA and Western blot). Pathology reviewed at NCI. Disease progression within past 2 months. At least 5 lesions measurable by non-invasive methods. No prior local therapy to these lesions. No pulmonary involvement. No potential or acutely life-threatening complications. Actively bleeding or critically located KS lesions eligible on a case-by- case basis. PRIOR/CONCURRENT THERAPY: Biologic Therapy: At least 4 weeks since interferon. Chemotherapy: At least 4 weeks since cytotoxic chemotherapy. No thalidomide since KS diagnosis. No suramin within 6 months. Endocrine Therapy: At least 4 weeks since steroids. Physiologic replacement doses of corticosteroids allowed. Radiotherapy: At least 4 weeks since radiotherapy. Surgery: Not specified. OTHER: At least 2 weeks since last antiretroviral therapy OR on stable doses of 1 or more of the following for at least 2 weeks: Zidovudine, Lamivudine, Dideoxycytidine, Stavudine, Dideoxyinosine, Protease inhibitor, Non-nucleoside reverse transcriptase inhibitor. PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: Karnofsky 70%-100%. Life expectancy: Greater than 3 months. Hematopoietic: ANC greater than 750. Platelet count at least 70,000. Hemoglobin at least 8 g/dL (at least 1 month since transfusion). Hepatic: Bilirubin no greater than 2.0 mg/dL. AST/ALT no greater than 125 U/L. PT or PTT no greater than 120% of control. No hepatic cirrhosis. Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance (estimated or measured) at least 70 mL/min per 1.73 square meters. Pulmonary: No reduced performance status beyond minimally symptomatic pulmonary disease. OTHER: No acutely life-threatening KS. No hypersensitivity to thalidomide or related compounds. Sedating "recreational" drugs and alcohol should be avoided (other sedating drugs should be reduced below minimal levels). No peripheral neuropathy greater than grade 1 except local neuropathy from mechanical cause or trauma. No grade 3 toxicity except lymphopenia or neutropenia. No severe infection within 2 weeks of entry. No fever of 39 C or greater within 10 days unless clearly unrelated to infection. No second malignancy within 1 year except completely resected basal cell carcinoma of the skin. Not pregnant. Negative pregnancy test required within 1 week of entry, every 4 weeks during treatment, and 4 weeks after study. Concurrent hormonal and barrier contraception required of fertile women from 1 week before entry through 4 weeks after treatment.
Total Enrollment: 32
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 960004; 96-C-0004
Study Start Date: October 14, 1995
Record last reviewed: July 1, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001492
Other Hiv Infection Studies:
1. A Pilot/Dose-Finding Study of the Toxicity, Anti-Kaposi's Sarcoma (KS) Activity, and Immunologic Activity of Interleukin-12 Administered to Patients with AIDS-Associated KS
2. Seroprevalence of Kaposi's Sarcoma Herpes Virus in the United States
3. Twins Study of Gene Therapy for HIV Infection
4. Assessment of Blood Vessel Density in Kaposi's Sarcoma Lesions
5. A Phase II Study of Oral Thalidomide for Patients with HIV Infection and Kaposi's Sarcoma
Related Studies:
Other HIV Infection Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
A Phase II Study of Oral Thalidomide for Patients with HIV Infection and Kaposi's Sarcoma
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