Status:
WITHDRAWN
Chemotherapy and Donor Stem Transplant for the Treatment of Patients With High Grade Brain Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Anaplastic Ependymoma
Atypical Teratoid/Rhabdoid Tumor
Eligibility:
All Genders
Up to 25 years
Phase:
PHASE1
Brief Summary
This phase I trial investigates the side effects and effectiveness of chemotherapy followed by a donor (allogeneic) stem cell transplant when given to patients with high grade brain cancer. Chemothera...
Detailed Description
PRIMARY OBJECTIVE: I. To assess tolerability of allogenic hematopoietic cell transplantation (HCT) among patients with chemo-responsive high-grade central nervous system (CNS) malignancies as defined...
Eligibility Criteria
Inclusion
- Pathological criteria for any high grade primary or recurrent malignant brain tumor - medulloblastoma (patients who are ineligible for tandem autologous transplants or who are at least 3 months post autologous HCT), primitive neuroectodermal tumor (PNET), atypical teratoid rhabdoid tumor (ATRT), malignant glioma, CNS germ cell tumor, intracranial sarcomas, choroid plexus carcinoma, anaplastic ependymoma. High grade tumors defined as those that are grade III or higher based on World Health Organization (WHO) classification grading system or for medulloblastoma: group 3 and 4 molecular subtypes
- Patients have to be in at least, a chemo-responsive disease status
- Available suitable HCT donor
- Creatinine clearance or glomerular filtration rate (GFR) \>= 50 ml/min/1.73m\^2, and not requiring dialysis
- Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) \>= 50% predicted. If unable to perform pulmonary function tests, then O2 saturation \>= 92% in room air
- Bilirubin =\< 3x upper limit of normal (ULN) (with the exception of isolated hyperbilirubinemia due to Gilbert's syndrome)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 5x for age
- DONOR: HCT will be done using stem cell sources in the following order of preference (and fulfilling minimal cell dose requirements per institutional standards):
- Matched related donor bone marrow (10 of 10 human leukocyte antigen \[HLA\] alleles \[HLA-A, B, C, DR, and DQ\]). Matched related donor peripheral blood stem cell (PBSC) is allowed only if collection of bone marrow (BM) is not available or refused by guardian/donor
- Matched allogeneic umbilical cord blood: related
- High-resolution matching at A,B, DRB1 (minimum 4/6)
- Killer-cell immunoglobulin-like receptor (KIR) major histocompatibility complex (MHC) class 1 preferential mismatch (minimum 4/6)
- Matched allogeneic umbilical cord blood: unrelated
- High-resolution matching at A,B, DRB1(minimum 4/6)
- KIR MHC class 1 preferential mismatch (minimum 4/6)
Exclusion
- Lack of histocompatible suitable graft source
- End-organ failure that precludes the ability to tolerate the transplant procedure, including conditioning regimen
- Renal failure requiring dialysis
- Congenital heart disease resulting in congestive heart failure
- Ventilatory failure: requires invasive mechanical ventilation
- Human immunodeficiency virus (HIV) infection
- Uncontrolled bacterial, viral, or fungal infections
- A female of reproductive potential who is pregnant, planning to become pregnant during the study, or is nursing a child
- Any patient who does not fulfill inclusion criteria listed above
Key Trial Info
Start Date :
January 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04521946
Start Date
January 14 2021
End Date
December 20 2022
Last Update
October 26 2024
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