Search / Trial NCT00001114

The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients With 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 December 03, 2023

Completed

Keywords

Sarcoma, Kaposi Didanosine Drug Interactions Acquired Immunodeficiency Syndrome Interferon Alpha

Description

Previous studies have shown that IFN-alpha can induce regression of Kaposi's sarcoma and suppression of HIV in some patients. Although various trials using IFN-alpha in combination with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity and evidence of HIV suppression, the overlapping toxicity (primarily neutropenia) of these two agents has proven dose-limiting. The toxicity profile of ddI suggests that this drug may be better tolerated than zidovudine when combined with IFN-alpha. Up to 90 patients are randomized to receive either low or high doses of...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Chemoprophylaxis for candidiasis and herpes simplex.
  • Up to 14 days of metronidazole.
  • Recombinant erythropoietin.
  • G-CSF (for severe cases of neutropenia).
  • Isoniazid for treatment of TB if given in conjunction with pyridoxine.
  • Required in patients with CD4 counts < 200 cells/mm3:
  • Prophylaxis for PCP.
  • PER AMENDMENT 9/19/96:
  • After the first 16 weeks of combined IFN alpha-2b and ddI treatment subjects may at the discretion of the investigator receive any FDA approved antiretroviral drug regimen in addition to or in place of ddI.
  • Patients must have:
  • Positive antibody to HIV.
  • Biopsy-proven Kaposi's sarcoma (at least 5 measurable lesions, with at least 1 measurable cutaneous lesion) involving the skin, lymph nodes, oral cavity, or asymptomatic lesions of the GI tract not requiring systemic chemotherapy. Lung involvement with Kaposi's sarcoma excludes.
  • Consent of parent or guardian if less than 18 years of age.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Concurrent opportunistic infection or B symptoms including unexplained fever, night sweats, weight loss > 10 percent, and diarrhea lasting more than 2 weeks.
  • Visceral (non-nodal) Kaposi's sarcoma requiring cytotoxic chemotherapy.
  • Severe (> 2+) tumor-associated edema.
  • Concurrent neoplasia other than basal cell carcinoma, or anogenital intraepithelial neoplasia.
  • Current clinical evidence of peripheral neuropathy (= or > grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not well controlled by anti-seizure medications.
  • Significant symptomatic cardiac disease.
  • Medical contraindication.
  • Concurrent Medication:
  • Excluded:
  • Other investigational, antiviral, immunomodulating, or antitumor agents.
  • Drugs associated with peripheral neuropathy (other than ddI).
  • PER AMENDMENT 9/19/96:
  • Other antiretroviral agents may not be taken during the first 16 weeks of combined IFN alpha-2b and ddI treatment.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy.
  • Patients with the following prior conditions are excluded:
  • Opportunistic infection or B symptoms including unexplained fever, night sweats, weight loss > 10 percent, and diarrhea lasting more than 2 weeks.
  • Prior grade 3 or 4 toxicity attributed to ddI therapy.
  • Prior history of peripheral neuropathy (= or > grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not well controlled by anti-seizure medications.
  • History of myocardial infarction or ventricular arrhythmias.
  • Prior Medication:
  • Excluded:
  • Prior IFN-alpha.
  • Corticosteroids, biological response modifiers, cytotoxic chemotherapy, or known neurotoxic drugs (other than ddI or ddC) within 30 days prior to study entry.
  • Therapy with antiretroviral drugs (other than ddI) within 7 days prior to study entry.
  • Prior Treatment:
  • Excluded:
  • Radiation therapy within 30 days prior to study entry.
  • Risk Behavior:
  • Alcohol consumption is strongly discouraged.
  • Patients considered to be noncompliant should be excluded.

Attachments

readout_NCT00001114_2023-12-03.pdf

4.5 MB

NCT00001114_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

Palo Alto, California, United States

Aurora, Colorado, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Boston, Massachusetts, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Buffalo, New York, United States

New York, New York, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

San Juan, , Puerto Rico

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
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?

Dries Vincent
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?

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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