Research

Leukemia and Solid Tumor Treatment with Obatoclax and Chemotherapy – Phase I

Obatoclax in Combination with Vincristine, Doxorubicin and Dexrazoxane in Children with Relapsed or Refractory Solid Tumors or Leukemia

Protocol Description

Through this Children’s Oncology Group Phase I trial researchers are investigating the effects of the drug obatoclax when used in chemotherapy to treat leukemia and solid tumors that have come back or proven to be resistant to standard treatment. Researchers will also be determining the highest dose that can be administered without causing bad side effects. It will be used in combination with vincristine and doxorubicin, drugs that seem to work against cancer, and dexrazozane, a medicine used to protect the heart.

Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, up to age 21, who have histologically confirmed refractory or relapsed solid tumor or lymphoma or recurrent or refractory mixed-lineage leukemia (MLL) or non-MLL.
Males: Up to 21 years
Females: Up to 21 years

Requirements
Treatment consists of up to 12, 28-day cycles, in which chemotherapy will be adminstered intravenously on the 1st and 8th days.
Frequency of visits: 3 times a month for chemotherapy and evaluation.
Duration: Up to 12 months.

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study ADVL08016)
National Cancer Institute
Third Party

Additional Resources
Study Description at National Institutes of Health