Sarcoma Clinical Trial
Official title:
Dose Escalation of Total Marrow Irradiation Added to an Alkylator-Intense Conditioning Regimen for Patients With High Risk or Relapsed Solid Tumors
Verified date | December 2017 |
Source | Masonic Cancer Center, University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 23 |
Est. completion date | October 2016 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose of tomotherapy up to 12 Gy | is a state-of-the- art means of delivering highly conformal radiation to tumors of targeted volume with high therapeutic gain. Tomotherapy offers unique advantages over total body irridiation and is expected to improve clinical outcome. The MTD is defined as the highest dose studied for which the incidence of dose limiting toxicity is less than 33%. | Day 42 | |
Secondary | Percent of patients who had PET scans and "spot radiation" to PET-positive lesions after transplantation | PET-CT scan is done prior to and after transplant. Radiation is given before and after transplant. | Day 60 Post Transplant | |
Secondary | Change in bone mineral density | the change in bone density and turnover in patients exposed to alkylator intensive conditioning regimen followed by tomographic total marrow irradiation (TMI). | Baseline, 6 and 12 Months Post Transplantation | |
Secondary | Rate of Treatment Related Mortality in Non-TMI Treated Patients | Determined in patients who were not treated with total marrow irradiation; all deaths without previous relapse or progression are usually considered as related to transplantation. | Day 100 Post Transplant | |
Secondary | Rate of Primary Neutrophil Engraftment | Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm3 (0.5 x 109/L) or greater. | Day 42 | |
Secondary | Overall Survival | Determined in patients not receiving total marrow irradiation. The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. | From date of enrollment to date of death or censored at the date of last documented contact | |
Secondary | Disease-Free Survival | In patients not receiving total marrow irradiation, the length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. | 1 Year |
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