The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients With Kaposi's Sarcoma
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Primary: To evaluate the safety, toxicity, and antitumor activity of two doses of interferon alfa-2b (IFN-alpha) combined with a fixed dose of didanosine (ddI) in patients with Kaposi's sarcoma associated with HIV infection.
Secondary: To evaluate the effects of combined IFN-alpha and ddI treatment on HIV expression and markers of immune function.
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.
Condition | Intervention | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections |
Drug: Interferon alfa-2b Drug: Didanosine |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
Official Title: | A Randomized Phase II Trial to Determine the Safety, Tolerance, and Efficacy of Two Doses of Interferon Alfa-2b Combined With Didanosine in Patients With Kaposi's Sarcoma |
Estimated Enrollment: | 90 |
Study Completion Date: | March 2000 |
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 IFN-alpha (1 or 10 million Units/day) in combination with a fixed dose of ddI. Fourteen patients are initially entered at each dose level. If no objective antitumor responses are observed among the first 14 patients at a given dose, no further patients are entered on that treatment arm. If one or more antitumor responses are seen at a given dose, up to 45 patients may be entered on that treatment arm. Patients must complete at least 4 weeks of study therapy to be considered evaluable for tumor response. Treatment is continued until tumor progression or unacceptable toxicity occurs. PER AMENDMENT 9/19/96: NOTE - After 16 weeks of treatment subjects may receive any FDA approved antiretroviral drug regimen in addition to or in place of ddI.
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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United States, California | |
Stanford CRS | |
Palo Alto, California, United States, 94115 | |
United States, Colorado | |
University of Colorado Hospital CRS | |
Aurora, Colorado, United States, 80262 | |
United States, Illinois | |
Northwestern University CRS | |
Chicago, Illinois, United States, 60611 | |
Rush Univ. Med. Ctr. ACTG CRS | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Indiana Univ. School of Medicine, Infectious Disease Research Clinic | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
Bmc Actg Crs | |
Boston, Massachusetts, United States, 02118 | |
United States, Missouri | |
St. Louis ConnectCare, Infectious Diseases Clinic | |
St Louis, Missouri, United States, 63112 | |
Washington U CRS | |
St. Louis, Missouri, United States | |
United States, New York | |
SUNY - Buffalo, Erie County Medical Ctr. | |
Buffalo, New York, United States, 14215 | |
Memorial Sloan-Kettering Cancer Ctr. | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Univ. of Cincinnati CRS | |
Cincinnati, Ohio, United States, 45267 | |
United States, Pennsylvania | |
Hosp. of the Univ. of Pennsylvania CRS | |
Philadelphia, Pennsylvania, United States, 19104 | |
Puerto Rico | |
Puerto Rico-AIDS CRS | |
San Juan, Puerto Rico, 00936 |
Study Chair: | Krown SE |
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Additional Information:
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001114 History of Changes |
Other Study ID Numbers: | ACTG 206, 11183 |
Study First Received: | November 2, 1999 |
Last Updated: | March 28, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Sarcoma, Kaposi Didanosine Drug Interactions Acquired Immunodeficiency Syndrome Interferon-alpha |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Sarcoma Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpesviridae Infections DNA Virus Infections |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue Interferon-alpha Interferon Alfa-2a Didanosine Interferon Alfa-2b Interferons Reaferon Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors |
ClinicalTrials.gov processed this record on February 21, 2013