Clinical trial · Interventional
Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma
Phase II Study of Recombinant Interferon Alpha and Etoposide in Patients With Relapsed Osteosarcoma
NCT00504140CI-TRIAL-00007720completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etoposide | Drug | Etoposide | ALIAS |
| Interferon Alpha | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interferon Alpha + Etoposide
- description
- Interferon Alpha 5x10\^6 mu/m\^2 subcutaneously and Etoposide 100 mg/m\^2 intravenously, both daily for 5 days
- interventionNames
- Drug: Etoposide
- Drug: Interferon Alpha
Primary outcomes (1)
- measure
- Number of Patients with Response when combining IFN with etoposide for the treatment of relapsed osteosarcoma.
- timeFrame
- Up to 24 - 32 weeks (8 courses of 3 - 4 weeks)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.