MT2004-30: Tomotherapy for Solid Tumors

• Status: Terminated
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: A peripheral blood stem cell transplant or bone marrow transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy and image-guided intensity-modulated radiation therapy used to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bone marrow radiation therapy followed by an autologous stem cell transplant in treating patients with high-risk or relapsed solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Busulfan; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Lenograstim; Melphalan; Mesna; Sargramostim; Thiotepa

Criteria

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.