Auto Transplant for High Risk or Relapsed Solid or CNS Tumors
Conditions
Hematopoietic Stem Cell Transplantation - Solid Tumor - Transplantation, Autologous
Conditions: Keywords
autologous transplantation, high risk solid tumor, relapsed solid tumor
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Ifosfamide Type: Drug
Name: Etoposide phosphate Type: Drug
Name: Mesna Type: Drug
Name: Granulocyte colony-stimulating factor Type: Biological
Name: Busulfan Type: Drug
Name: Melphalan Type: Drug
Name: Thiotepa Type: Drug
Name: Autologous stem cell infusion Type: Biological
Name: Radiation Type: Radiation
Name: Caboplatin Type: Drug
Overall Status
Recruiting
Summary
This is a standard of care treatment guideline for high risk or relapsed solid tumors or CNS tumors consisting of a busulfan, melphalan, thiotepa conditioning (for solid tumors) or carboplatin and thiotepa conditioning (for CNS tumors) followed by an autologous peripheral blood stem cell transplant. For solid tumors, if appropriate, disease specific radiation therapy at day +60. For CNS tumors, the conditioning regimen and autologous peripheral blood stem cell transplant will be given for 3 cycles.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

All patients must have histological verification of malignancy at original diagnosis.

- Eligible Diseases: Arm A Solid Tumor

- Ewing's Family Tumors (ES/PNET/DSRCT) - metastatic at 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 time of diagnosis and/or relapsed after therapy

- Rhabdomyosarcoma - metastatic at time of diagnosis and/or relapsed after therapy

- Soft Tissue Sarcoma - chemotherapy responsive metastatic disease or chemotherapy responsive relapsed disease

- Primary Malignant Brain Neoplasms <18 years of age - at diagnosis and/or relapse

- Retinoblastoma - disseminated at diagnosis and/or relapsed

- Other High Risk Metastatic or Relapsed Solid Tumors - to be approved by 2 or more pediatric hematology/oncology and bone marrow transplant (BMT) physicians

- Eligible Diseases: Arm B Certain CNS tumors

- Medulloblastoma: Children less than 36 months (3 years) of age at time of definitive surgery (for histopathologic diagnosis) who have high risk Medulloblastoma, defined as any one of the following:

- > 1.5 cm2 residual disease following resection for any Medulloblastoma histology

- lumbar CSF cytology positive for tumor cells by analysis of fluid collected either before definitive surgery or at least 10 days after definitive surgery

- MRI evidence of (a) gross nodular seeding in the intracranial subarachnoid space or ventricular system distant from primary tumor site, M2; or (b) gross nodular seeding in the spinal subarachnoid space +/- evidence of intracranial seeding, M3; or (c) extraneural metastases, M4,

- Anaplastic Histologic Variant Medulloblastoma: less than 70 years of age, any metastatic stage, with total or sub-total resection.

- Infant Medulloblastoma: Children less than 8 months of age at the time of definitive surgery (for histopathologic diagnosis), any histology, any metastatic state, with total or sub-total resection.

- Supra-tentorial Primative Neuro-Ectodermal Tumor (PNET): Children less than 36 months (3 years) of age at time of definitive surgery (for histopathologic diagnosis) with or without metastatic disease

- Atypical Teratoid/Rhabdoid Tumor (AT/RT): less than 70 years of age with CNS AT/RT (with or without metastatic disease).

- Other High Risk CNS Tumors - to be approved by 2 or more physicians (at least one oncologist and one BMT physician).

- Disease Status at Enrollment must have fit one of the following:

- no evidence of disease or

- stable, non-progressive disease (defined as non-progressive abnormalities on physical exam or CT and/or MRI) within 4 weeks of study entry

- Age and Performance Status

- Age: 0 - 70 years

- Performance status: Karnofsky Performance Status at least 50% for patients > 16 years of age or Lansky Play Score at least 50 for patients less than or equal to 16 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: hemoglobin of >9 gm/dl and platelet count > 20,000/μl. Patients may receive transfusions as necessary.

- Renal: Glomerular Filtration Rate (GFR) ≥ 50 ml/min/1.73m2 or serum creatinine ≤ 2.5 x upper limit of normal (ULN) for age

- Hepatic: aspartate aminotransferase or 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:

- Pregnant or breastfeeding

- Active, uncontrolled infection and/or human immunodeficiency virus (HIV) positive
Location
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Michael Verneris, M.D. - 612-626-2961 - verneris@umn.edu
Start Date
October 2011
Completion Date
December 2016
Sponsors
Masonic Cancer Center, University of Minnesota
Source
Masonic Cancer Center, University of Minnesota
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page