RO4929097 in Children With Relapsed/Refractory Solid or CNS Tumors, Lymphoma, or T-Cell Leukemia
Status:
Withdrawn
Trial end date:
2011-04-13
Target enrollment:
Participant gender:
Summary
Background:
- The anti-cancer drug RO4929097 is being tested for its ability to block blood vessel growth
to tumors and slow or stop the growth of cancer cells. However, it has been used in only a
small number of adults and has not yet been tested in children. Researchers are interested in
determining whether RO4929097 is a safe and effective treatment for tumors or leukemia that
has not responded to standard treatment.
Objectives:
- To determine the safety and effectiveness of RO4929097 as a treatment for children and
adolescents who have been diagnosed with certain kinds of cancer that have not responded to
standard treatment.
Eligibility:
- Children, adolescents, and young adults between 1 and 21 years of age who have been
diagnosed with solid, nervous system, or blood-based cancers that have not responded to
standard treatment.
Design:
- Participants will be screened with a medical history, physical examination, blood and
urine tests, and imaging studies. Some participants may also have a bone marrow biopsy
to evaluate the state of their disease.
- Participants will be separated into three groups: One group will receive RO4929097
alone, and the other two will receive RO4929097 in combination with the
immune-suppressing drug dexamethasone.
- RO4929097 will be given as tablets on one of two schedules: days 1 to 3 of every week
(Schedule A) or days 1 to 5 of every week (Schedule B). The dosing schedule will be
determined randomly. Every 4-week treatment period is one cycle, and participants may
receive RO4929097 for up to 24 cycles.
- Participants will have frequent blood and urine tests and imaging studies to evaluate
the progress of treatment, and will be asked to keep a diary to monitor any side
effects.