Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma
- To determine the efficacy of combining Interferon Alpha (IFN) with etoposide for the treatment of relapsed osteosarcoma.
- To determine if IFN alters the plasma pharmacokinetics of etoposide.
- To determine the toxicities of IFN and etoposide when administered together.
- To determine IFN blood levels following combination therapy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Recombinant Interferon Alpha and Etoposide in Patients With Relapsed Osteosarcoma|
- Number of Patients with Response when combining IFN with etoposide for the treatment of relapsed osteosarcoma. [ Time Frame: Up to 24 - 32 weeks (8 courses of 3 - 4 weeks) ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 1996|
|Study Completion Date:||March 2009|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
Experimental: Interferon Alpha + Etoposide
Interferon Alpha 5x10^6 mu/m^2 subcutaneously and Etoposide 100 mg/m^2 intravenously, both daily for 5 days
100 mg/m^2 Intravenous Daily for 5 days, beginning one hour after IFN-alpha treatment.
Other Name: VP-16Drug: Interferon Alpha
5x10^6 mu/m^2 Subcutaneously Daily for 5 Days
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 investigational.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504140
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eugenie S. Kleinerman, MD||M.D. Anderson Cancer Center|