Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Schering-Plough
• Treatments: Etoposide; Etoposide phosphate; Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

1. Patients with histologically confirmed relapsed osteosarcoma who have failed standard chemotherapy.

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:

1. Patients who are likely to have significant systems because of rapidly progressive disease, ascites or hepatic metastasis.

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.