Tumor and Acute Lymphoblastic Leukemia Treatment with BMN 673 and Temozolomide – Phase I/II

BMN 673, an Oral Poly Polymerase Inhibitor, Plus Temozolomide in Children with Refractory or Recurrent Malignancies

Protocol Description

This multicenter trial by the Children’s Oncology Group seeks to determine the best dose of BMN 673 and temozolomide and to see how well they work in treating younger patients with tumors that have come back or have not responded to standard therapy. BMN 673 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Researchers believe that giving BMN-673 together with temozolomide may work better in younger patients with refractory or recurrent malignancies.

Study Level: Phase I/II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients of both genders ages 13 months to 21 years for Phase I of the study, or up to 30 years of age for Phase II, who have been diagnosed as having recurrent or refractory malignancies, including solid tumors, Ewing sarcoma and acute lymphoblastic leukemia.
Males and Females: Ages 13 months to 30 years

Requirements

Patients enrolled in the study will take BMN 673 orally on the first day of treatment, and in combination with temozolomide on days 2 through 5. This pattern will be repeated in 28-day cycles for up to 24 cycles.
Visits: About 15 clinic visits during the first cycle, and thereafter about once a week
Duration: About 2 years, depending on outcomes

Status: Enrollment is limited. Please call to check status.

Source(s) of Support

Children’s Oncology Group (ADVL1411)
National Cancer Institute, Cancer Therapy Evaluation Program

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN
412-692-8864