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Home > "A" Clinical Trials Conditions > A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma  A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma
A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): Novum , National Institute of Allergy and Infectious Diseases (NIAID),Bristol-Myers Squibb
Synopsis: To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC). AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections.
Details: AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections. In Phase I, eligible patients with advanced Kaposi's sarcoma are randomly assigned to either ddI or ddC in combination with DBV chemotherapy. On the average, patients receive 12-44 weeks of combined chemotherapy and antiretroviral therapy. If vincristine is deleted from Phase I because of excess neurotoxicity, it will not be administered as part of the combination chemotherapy if that treatment is continued in the Phase II study. The Phase II trial proceeds when at least six cycles (12 weeks) of DBV have been completed by six patients enrolled in Phase I, and an overall evaluation of tolerance to each combination treatment plan has been completed. Study medication is administered as in Phase I, with the possible deletion of vincristine. All patients who complete DBV chemotherapy with complete or partial response or stable disease will continue to receive the originally assigned investigational antiretroviral drug (ddC or ddI) for an additional 24 weeks.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Prophylaxis for Pneumocystis carinii pneumonia for all patients with CD4 cell counts < 200 cells/mm3. Allowed: - Chemoprophylaxis for candidiasis, MAC, and herpes simplex. - Up to 14-day courses of metronidazole. - Recombinant erythropoietin. - Granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte colony stimulating factor (G-CSF) for patients with ANC < 1000 cells/mm3. - Isoniazid for treatment of tuberculosis, with permission of the protocol chair, when given in conjunction with pyridoxine. Patients must have: - HIV infection. - Kaposi's sarcoma. For patients < 18 years of age: - consent of parent or guardian. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Opportunistic infection requiring treatment with myelosuppressive antibiotics (unless on G-CSF or GM-CSF). - Other active malignancies except basal cell carcinoma of the skin or in situ cervical carcinoma. - Prior history or current clinical evidence of peripheral neuropathy (= or > grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not controlled by antiseizure medication. - Significant pulmonary insufficiency (exertional dyspnea with minimal exertion, except that due to pulmonary Kaposi's sarcoma) or cardiac insufficiency (New York Heart Association status > 2). - Neuropsychiatric history or altered mental status that would prevent informed consent or that would not permit compliance with this protocol. Concurrent Medication: Excluded: - Myelosuppressive antibiotics (unless on G-CSF or GM-CSF). - Investigational agents other than drugs available on treatment IND and used for FDA sanctioned indications, or other antiviral, immunomodulating or antitumor drugs. - Drugs associated with peripheral neuropathy (other than ddI, ddC, or vincristine), including hydralazine, disulfiram, nitrofurantoin, cisplatin, diethyldithiocarbamate, gold, rifampin, chloramphenicol, clioquinol, ethambutol, ethionamide, glutethimide, sodium cyanate, and thalidomide. Patients with the following prior conditions or symptoms are excluded: - Neuropsychiatric history or altered mental status that would prevent informed consent or that would not permit compliance with this protocol. Prior Medication: Excluded: - Systemic treatment with doxorubicin, bleomycin, or vincristine. - Antitumor (Kaposi's sarcoma) drugs within 7 days of study entry. - Any investigational drug (other than drugs available on treatment IND and used for FDA sanctioned indications) within 14 days of study entry. - Neurotoxic drugs (other than ddI or ddC) within 30 days of study entry. - Intralesional injections to a Kaposi's sarcoma marker lesion within 30 days of study entry. Prior Treatment: Excluded: - Irradiation of a Kaposi's sarcoma marker lesion within 30 days of study entry. Alcohol consumption is strongly discouraged.
Total Enrollment: 72
Location and Contact Information:
Overall Study Official:
MitsuyasuRT, Study Chair,
Mid - Hudson Care Ctr
Albany, New York, 122083479
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Adirondack Med Ctr at Saranac Lake
Albany, New York, 122083479
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Girard Med Ctr
Philadelphia, Pennsylvania, 191046073
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr
Los Angeles, California, 900331079
United States
Denver Dept of Health and Hosps
Denver, Colorado, 80262
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Additional Information:
Study ID Numbers: ACTG 163;
Study Start Date:
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000954
Other Hiv Infections Studies:
1. A Study of Immune System Activity in Healthy Adults
2. Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV
3. A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)
4. A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of the Therion Recombinant Vaccinia-HIV-1 IIIB ENV/GAG/POL Vaccine (TCB-3B) and MN RGP 120/HIV-1 In Alum.
5. Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
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Other New York City Clinical Trials
A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma
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