MT2004-30: Tomotherapy for Solid Tumors

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, childhood hepatoblastoma, recurrent childhood liver cancer, stage IV childhood liver cancer, adult primary liver cancer, previously treated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, recurrent Wilms tumor and other childhood kidney tumors, stage IV Wilms tumor, stage V Wilms tumor, rhabdoid tumor of the kidney, stage IV renal cell cancer, childhood mixed glioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood ependymoma, recurrent childhood medulloblastoma, recurrent childhood pineoblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood visual pathway glioma, untreated childhood brain stem glioma, untreated childhood cerebellar astrocytoma, childhood infratentorial ependymoma, childhood supratentorial ependymoma, childhood high-grade cerebellar astrocytoma, childhood high-grade cerebral astrocytoma, childhood low-grade cerebellar astrocytoma, childhood low-grade cerebral astrocytoma, newly diagnosed childhood ependymoma, childhood atypical teratoid/rhabdoid tumor, recurrent retinoblastoma, extraocular retinoblastoma, intraocular retinoblastoma, childhood renal cell carcinoma, clear cell renal cell carcinoma, recurrent renal cell cancer, recurrent childhood visual pathway and hypothalamic glioma, unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific Read More

Inclusion Criteria:

• Diagnosis Patients must have had histologic verification of malignancy at original diagnosis. Diseases included are:

  • Ewing's Family Tumors (ES/PNET/DSRCT): metastatic at the time of diagnosis and/or relapsed after therapy
  • Renal tumors: relapsed (all histology-Wilm's tumor) or at diagnosis (clear cell sarcoma and Rhabdoid tumor),
  • Hepatoblastoma: metastatic at the time of diagnosis and/or relapsed after therapy
  • Rhabdomyosarcoma: metastatic at the time of diagnosis and/or relapsed after therapy
  • Soft tissue sarcomas: chemotherapy responsive metastatic disease or chemotherapy responsive relapsed disease
  • Primary Malignant Brain Neoplasms at diagnosis and/or relapse
  • Retinoblastoma: disseminated at diagnosis and/or relapsed
  • Other High Risk Metastatic or Relapsed Solid Tumors: To be approved by two or more physicians on the study committee
• Disease Status: Patients must have either: 1) no evidence of disease or 2) stable, non-progressive disease (defined as non-progressive abnormalities on physical exam or computated tomography (CT) and/or magnetic resonance imaging [MRI]) within 4 weeks of study entry.
• Age: Patients must be 0-70 years of age at the time of study entry.
• Performance Level: Karnofsky > or = 50% for patients > 10 years of age and Lansky > or = 50% for patients < or = 10 years of age. Note: Neurologic deficits in patients with central nervous system (CNS) tumors must be stable for a minimum of 1 week prior to study entry.

• Organ Function:

  • Hematologic: prior to receiving total marrow irradiation (TMI) patients should have a hemoglobin of >10 gm/dl and a platelet count > 20,000/μl. Patients may receive transfusions as necessary.
  • Renal: glomerular flow rate (GFR) ≥ 50 ml/min/1.73m^2 or serum creatinine ≤ 2.5 x upper limit of normal (ULN) for age
  • Hepatic: aspartate aminotransferase/alanine aminotransferase (AST or ALT) ≤ 5 x ULN and bilirubin ≤ 5 x ULN
  • Cardiac: ejection fraction > 45% or no clinical evidence of heart failure
  • Pulmonary: oxygen saturation > 92% at rest (on room air)

Exclusion Criteria:

• Disease Status: patients with progressive, non-therapy responsive disease will not be eligible.
• Infection: patients who have active, uncontrolled infections or those who are HIV+.
• Pregnancy or Breast-Feeding: pregnant or breast-feeding women will not be entered on this study.
• Prior Radiation Therapy: patients must be eligible to receive TMI via tomographic radiation therapy (as determined by radiation oncology staff). If not eligible (due to extensive prior radiation or other circumstances), patients can be treated on study but will not receive radiation and will be analyzed on a separate arm.