A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 10, 2025
Completed
Keywords
ClinConnect Summary
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 neuro...
Gender
ALL
Eligibility 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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Buffalo, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Columbus, Ohio, United States
Patients applied
Trial Officials
Mitsuyasu RT
Study Chair
Gill PS
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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