HEAD START 4: A Study of Different Regimens of Induction and Consolidation Chemotherapy with Stem Cell Rescue for Children Newly Diagnosed with Brain and Spinal Cord Tumors

Full Title

HEAD START 4 PROTOCOL: Newly Diagnosed Children (Less than 10 Years Old) With Medulloblastoma and Other Central Nervous System Embryonal Tumors. Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation with Randomization to either Single-Cycle or to Three Sequential Cycles of Marrow-Ablative Chemotherapy with Autologous Hematopoietic Progenitor Cell Rescue

Purpose

The purpose of this study is to compare two different treatment regimens for children under age 10 newly diagnosed with medulloblastoma (a type of brain tumor) and other embryonal tumors in the brain or spinal cord. The drugs in this study have all been used to treat children with brain cancer; what is new is the way they are being given.

  • During the induction phase, each child’s tumor will be tested for biologic and genetic markers that will help doctors know how to best treat the child. Patients will receive three cycles of chemotherapy (five if there is still residual tumor remaining after three cycles).
  • Each child will then have some of their own stem cells in the blood collected for later use. After the stem cells have been collected, they will be stored and then given again after the consolidation phase, to help the child’s blood-forming system to re-establish itself.
  • Based on the results of the tumor marker tests, patients will be randomly assigned to receive either one or three cycles of consolidation chemotherapy. Children with low-risk medulloblastoma will all receive a single cycle of consolidation therapy.
  • Patients will then receive an infusion of their stored stem cells.
  • Children who show evidence of residual tumor tissue despite the study treatment will receive radiation therapy.

In addition to comparing the effectiveness of these treatments, researchers will evaluate their effects on each child’s quality of life, brain function, and hearing.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • This study is for children under age 10 years who were newly diagnosed with medulloblastoma or another embryonal tumor in the brain or spinal cord.
  • Patients may not have previously received chemotherapy or radiation therapy.
  • Patients who had surgery to remove their cancer must begin induction chemotherapy within 4 weeks of the surgical procedure.

For more information about this study and to inquire about eligibility, please contact Dr. Kim Kramer at 212-639-3751.

Protocol

17-475

Phase

IV

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators