New Therapeutic Strategies for Patients With Ewing's Sarcoma Family of Tumors, High Risk Rhabdomyosarcoma, and Neuroblastoma

Fecha de inicio: 1 de abril de 1993

The patient must fall into one of the following diagnostic categories: Ewing's sarcoma family of tumors (ESF): Includes Ewing's sarcoma (classic, atypical, extra-osseous), primitive sarcoma of bone, ectomesenchymoma, or peripheral primitive neuroectodermal tumor (peripheral neuroepithelioma). Rhabdomyosarcoma: The patient must have either High-risk arm: Metastatic disease at diagnosis (any site, any histology); OR Moderate-risk arm: Incompletely resected ( Clinical Group III) Stage II tumors and ALL stage III tumors (regardless of degree of surgical resection). Neuroblastoma: Any patient with metastatic disease at diagnosis (POG stage D or Evans' stage IV); or, patients with loco-regional metastatic disease (POG stage C) or tumor infiltrating across the midline (Evans' stage III) IF they have an elevated serum ferritin (greater than 142 ng/ml), an amplified N-myc copy number (greater than 10 copies on Southern analysis), or a DNA index of greater than 1.1. The patient must not have been previously treated with chemotherapy or radiation therapy. Patients must be greater than or equal to 1 year of age but less than or equal to 25 years of age. Patients weight must be greater than or equal to 15 kg. The patient (or his/her guardian if less than 18 years of age) must sign a document indicating that he/she is aware of the investigational nature of this treatment protocol and the potential risks and benefits that may be expected. Potentially fertile female patients must have a documented negative urine or serum pregnancy test. Patients must have a documented negative HIV serologic evaluation (Western Blot and/or ELISA). Patients must not have abnormal cardiac function (left ventricular ejection fraction less than 45% as measured by gated equilibrium radionuclide angiography [MUGA scan] and confirmed by echocardiography). Patients must not have impaired renal function (serum creatinine greater than or equal to twice the upper limit of normal for age). Patients with a total bilirubin of greater than 4.0 mg/dl (or a direct bilirubin of greater than 2.0 mg/dl) or SGOT/SGPT greater than five times the upper limits of normal (NOT on the basis of hepatic involvement by tumor) will be excluded. Patients with a second malignancy following previous therapy will be excluded. Patients previously treated with chemotherapy or radiation therapy (other than limited, emergency radiation therapy) will be excluded. Patients who are HIV-infected will be excluced.