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Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma
Not Recruiting
Trial ID: NCT00134030
Purpose
This randomized phase III trial is studying combination chemotherapy followed by surgery and
two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to
compare how well they work in treating patients with osteosarcoma. Drugs used in chemotherapy
work in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill
more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with
the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the
tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon
alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving
combination therapy together with PEG-interferon alfa-2b is more effective than two different
combination chemotherapy regimens alone after surgery in treating osteosarcoma.
Official Title
A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-operative Chemotherapy
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Histologically confirmed high-grade osteosarcoma, including second malignancies
- Localized or metastatic disease
- The primary tumor must be located in the limbs or axial skeleton, including any
of the following sites*:
- Long bone of upper limb
- Short bone of upper limb
- Long bone of lower limb
- Short bone of lower limb
- Vertebral column
- Ribs, sternum, clavicle, or scapula
- Pelvic bones, sacrum, or coccyx
- Tumor (primary, metastatic, or both) resectable OR is expected to become resectable
after neoadjuvant induction chemotherapy
- Suitable for neoadjuvant chemotherapy
- Performance status - Lansky 50-100% (for patients under 16 years of age)
- Performance status - Karnofsky 50-100%*
- Performance status - WHO or ECOG 0-2*
- Platelet count ≥ 100,000/mm³
- Neutrophil count ≥ 1,500/mm³
- WBC ≥ 3,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal
- Creatinine clearance ≥ 70 mL/min
- Creatinine based on age as follows:
- No greater than 1.0 mg/dL (for patients 5 to 10 years of age)
- No greater than 1.2 mg/dL (for patients 11 to 15 years of age)
- No greater than 1.5 mg/dL (for patients over 15 years of age)
- Ejection fraction ≥ 50% by radionuclide angiogram
- Shortening fraction ≥ 28% by echocardiogram
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- No prior chemotherapy for any disease
- Prior radiotherapy for another malignancy allowed
- No prior treatment for osteosarcoma
- No patients with any of the following:
- Craniofacial osteosarcoma
Intervention(s):
drug: cisplatin
drug: doxorubicin hydrochloride
drug: etoposide
drug: ifosfamide
drug: methotrexate
biological: peginterferon alfa-2b
procedure: therapeutic conventional surgery
other: questionnaire administration
other: Quality-of-Life Assessment
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535