Status:
TERMINATED
MT2004-30: Tomotherapy for Solid Tumors
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Brain and Central Nervous System Tumors
Kidney Cancer
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose of tomographic total marrow irradiation (TMI) when given prior to an alkylator-intensive conditioning regimen in patients with high-risk...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00623077
Start Date
August 1 2005
End Date
October 1 2016
Last Update
December 5 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455