Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma
NCT ID: NCT00504140
Last Updated: 2012-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
1996-11-30
2009-03-31
Brief Summary
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1. To determine the efficacy of combining Interferon Alpha (IFN) with etoposide for the treatment of relapsed osteosarcoma.
2. To determine if IFN alters the plasma pharmacokinetics of etoposide.
3. To determine the toxicities of IFN and etoposide when administered together.
4. To determine IFN blood levels following combination therapy.
Detailed Description
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Patients who are candidates for surgery will first receive two courses of treatment. If the tumor gets worse or if severe side effects occur, treatment will be stopped, and the tumor will be removed right away. If the tumor responds well (begins to shrink or does not get worse) and severe side effects do not occur, the patient will receive six more courses of treatment after surgery.
Patients who are not candidates for surgery will receive two initial courses of treatment. If the tumor responds well and severe side effects do not occur, the patient will receive six more courses of treatment.
The treatment will be given in the outpatient department. Before treatment begins, the patient will have a health examination. Blood tests, a urine test, and heart tests will be given. X-rays, computed tomography (CT) scans, and a bone scan will be done. The location and size of all lesions will be recorded.
During treatment, patients will have a blood test every week. Before each course, a health examination, a urine test, and chest x-ray will be given and the size of all measurable cancer will be recorded. After the second course, the CT and bone scans will be repeated. All the tests will be repeated at the end of the study.
About 37 patients will be treated on the study at M. D. Anderson.
THIS IS AN INVESTIGATIONAL STUDY. IFN- and VP-16 are approved by the U.S. Food and Drug Administration for treating some types of cancer. Their use together against osteosarcoma is investigational.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Interferon Alpha + Etoposide
Interferon Alpha 5x10\^6 mu/m\^2 subcutaneously and Etoposide 100 mg/m\^2 intravenously, both daily for 5 days
Etoposide
100 mg/m\^2 Intravenous Daily for 5 days, beginning one hour after IFN-alpha treatment.
Interferon Alpha
5x10\^6 mu/m\^2 Subcutaneously Daily for 5 Days
Interventions
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Etoposide
100 mg/m\^2 Intravenous Daily for 5 days, beginning one hour after IFN-alpha treatment.
Interferon Alpha
5x10\^6 mu/m\^2 Subcutaneously Daily for 5 Days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 5-70 years.
3. Life expectancy of at least 12 weeks and a Zubrod performance status of less than or equal to 2.
4. Patients must have measurable disease.
5. Adequate hematologic, coagulation, renal, and hepatic function.
6. No chemotherapy, immunotherapy, hormonal therapy or radiation therapy within 3 weeks of study entry.
Exclusion Criteria
2. Pregnant or lactating women.
3. Patients who have had more than one prior biologic response modifier.
4. Serious intercurrent illness, active infections, or central nervous system (CNS) disease.
5. Patients of childbearing potential, not practicing adequate contraception.
6. Significant cardiovascular disease.
5 Years
70 Years
ALL
No
Sponsors
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Schering-Plough
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Eugenie S. Kleinerman, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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The University of Texas M.D.Anderson Cancer Center
Other Identifiers
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P96-221
Identifier Type: -
Identifier Source: org_study_id