Chemotherapy and Donor Stem Transplant for the Treatment of Patients With High Grade Brain Cancer
NCT04521946 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2024-10-26
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. Chemotherapy drugs, such as fludarabine, thiotepa, etoposide, melphalan, and rabbit anti-thymocyte globulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells.
Conditions
- Anaplastic Ependymoma
- Atypical Teratoid/Rhabdoid Tumor
- Central Nervous System Germ Cell Tumor
- Choroid Plexus Carcinoma
- Intracranial Myeloid Sarcoma
- Malignant Brain Neoplasm
- Malignant Glioma
- Medulloblastoma
- Primitive Neuroectodermal Tumor
- Recurrent Anaplastic Ependymoma
- Recurrent Atypical Teratoid/Rhabdoid Tumor
- Recurrent Malignant Brain Neoplasm
- Recurrent Malignant Glioma
- Recurrent Medulloblastoma
- Recurrent Primitive Neuroectodermal Tumor
Interventions
- DRUG
-
Etoposide
Given IV
- DRUG
-
Fludarabine Phosphate
Given IV
- PROCEDURE
-
Hematopoietic Cell Transplantation
Undergo HCT
- BIOLOGICAL
-
Lapine T-Lymphocyte Immune Globulin
Given IV
- DRUG
-
Melphalan
Given IV
- DRUG
-
Mycophenolate Mofetil
Given PO or IV
- DRUG
-
Given IV
- DRUG
-
Thiotepa
Given IV
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Kris M Mahadeo, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-01-14
- Primary Completion
- 2022-12-20
- Completion
- 2022-12-20
- FDA Drug
- Yes
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