Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objectives:

        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: 
      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.
    

Intervention name(s): Etoposide; Interferon Alpha
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg/m^2 Intravenous Daily for 5 days, beginning one hour after IFN-alpha treatment.; 5x10^6 mu/m^2 Subcutaneously Daily for 5 Days
Other intervention name(s): VP-16; IFN-; Roferon
Intervention MeSH terms: Interferons; Interferon-alpha; Etoposide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteosarcoma; Interferon Alpha; IFN-; Roferon; Recombinant Interferon Alpha; Etoposide; VP-16