Search / Trial NCT00000954

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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Vincristine Sarcoma, Kaposi Zalcitabine Didanosine Doxorubicin Drug Evaluation Drug Interactions Drug Therapy, Combination Combined Modality Therapy Acquired Immunodeficiency Syndrome Antineoplastic Agents Antineoplastic Agents, Combined Antiviral Agents Bleomycin

Description

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.

Attachments

readout_NCT00000954_2024-05-23.pdf

4.5 MB

NCT00000954_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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