Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors

Summary

This phase I/II trial studies the side effects and best dose of melphalan when given together with carboplatin, mannitol, and sodium thiosulfate, and to see how well they work in treating patients with central nervous system (CNS) embryonal or germ cell tumors that is growing, spreading, or getting worse (progressive) or has come back (recurrent). Drugs used in chemotherapy, such as melphalan and carboplatin, 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. Osmotic blood-brain barrier disruption (BBBD) uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Sodium thiosulfate may help lessen or prevent hearing loss and toxicities in patients undergoing chemotherapy with carboplatin and BBBD. Giving melphalan together with carboplatin, mannitol, and sodium thiosulfate may be an effective treatment for recurrent or progressive CNS embryonal or germ cell tumors.

Conditions

• Central Nervous System Embryonal Neoplasm
• Embryonal Tumor With Multilayered Rosettes, C19MC-Altered
• Germ Cell Tumor
• Medulloblastoma
• Medulloepithelioma
• Primitive Neuroectodermal Tumor
• Recurrent Childhood Central Nervous System Embryonal Neoplasm
• Recurrent Malignant Germ Cell Tumor
• Recurrent Medulloblastoma
• Recurrent Primitive Neuroectodermal Tumor

Interventions

DRUG

Carboplatin

Given IA

DRUG

Mannitol

Given IA

DRUG

Melphalan

Given IA

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Sodium Thiosulfate

Given IV

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Oregon Health and Science University

  collaborator OTHER

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Edward A Neuwelt · OHSU Knight Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-07-09

Primary Completion

2021-12-31

Completion

2022-12-31

FDA Drug

Yes

Countries

• United States

Study Locations