Gene Therapy Clinical Trials
Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
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
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
Ages Eligible for Study
5 Years - 40 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting