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NCT04521946 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL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

No results posted yet for this study

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

Tacrolimus

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04521946 on ClinicalTrials.gov