Phase II Study of Recombinant Interferon Alpha and Etoposide in Patients With Relapsed Osteosarcoma
Interferon Alpha (IFN)- will be given as a shot under the skin. One hour later, VP-16 will
be infused through a catheter (tube) placed in a vein over 3 hours. The drugs will be given
daily for 5 days. The treatment will be repeated every 3 - 4 weeks for up to 24 - 32 weeks
(8 courses). The catheter will remain in place throughout treatment.
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Response when combining IFN with etoposide for the treatment of relapsed osteosarcoma.
Complete Response (CR): Disappearance of all evidence of tumor for at least one cycle; Lytic or mixed bone lesions improved by scan or shown some ossification by x-ray; and free of all symptoms of cancer. Partial Response (PR): 50% or > decrease in sum of product of diameters of all measured lesions persisting for at least one cycle or 4 weeks. No lesion may increase in size or new lesion appear. Minor Response (MR): Decrease in measurable lesion(s) too small or too brief to qualify as Partial Response.
Up to 24 - 32 weeks (8 courses of 3 - 4 weeks)
Eugenie S. Kleinerman, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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