Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma

Completed · Phase 2

Conditions studied: Osteosarcoma

In brief

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.

Key facts

Study ID

NCT00504140

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

1996-11-01

Expected to finish

2009-03-01

Last updated by the study team

2012-08-02

Who can join

Age: 5 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically confirmed relapsed osteosarcoma who have failed standard chemotherapy.
• Age 5-70 years.
• Life expectancy of at least 12 weeks and a Zubrod performance status of less than or equal to 2.
• Patients must have measurable disease.
• Adequate hematologic, coagulation, renal, and hepatic function.
• No chemotherapy, immunotherapy, hormonal therapy or radiation therapy within 3 weeks of study entry.

You may not qualify if…

• Patients who are likely to have significant systems because of rapidly progressive disease, ascites or hepatic metastasis.
• Pregnant or lactating women.
• Patients who have had more than one prior biologic response modifier.
• Serious intercurrent illness, active infections, or central nervous system (CNS) disease.
• Patients of childbearing potential, not practicing adequate contraception.
• Significant cardiovascular disease.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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