Research

CNS Tumor Treatment with SAHA – Phase I

SAHA and Temozolomide in Children with Relapsed or Refractory Primary Brain or Spinal Cord Tumors

Protocol Description

This Children’s Oncology Group Phase I trial is studying the side effects and best dose of suberoylanilide hydroxamic acid (SAHA) when given with temozolomide in treating young patients with relapsed or refractory primary brain tumors or spinal cord tumors. Researchers believe that SAHA may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. SAHA may make tumor cells more sensitive to the chemotherapy drug temozolomide.

Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, ages 1 to 21, who have been diagnosed with a confirmed central nervous system (CNS) malignancy cannot be cured by any known standard treatment.
Males: Ages 1 to 21 years
Females: Ages 1 to 21 years

Requirements
Treatment consists of up to 13, 28-day cycles in which chemotherapy will be administered orally on each of the first five days. Blood tests, electrocardiograms, urine tests and imaging studies will also be done. There will be up to four groups of participants, with dose levels increased successively for each of the last three groups.
Frequency of visits: Weekly
Duration: Up to 12 months for participants who respond to the therapy

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study ADVL0912)
National Cancer Institute

Additional Resources
Study Description at National Institutes of Health