This phase 1/2 clinical trial will test the safety of bortezomib(Velcade) and vorinostat(Zolinza) with standard chemotherapy in treating infants with acute lymphoblastic leukemia (ALL). The primary outcome will be measured by the tolerability to the treatment.
The details
Bortezomib is a treatment that inhibits the proteasome, a part of the cancer cell. This can lead to cancer cell death. Vorinostat is another type of treatment that can slow cell division and lead to cancer cell death. These treatments are currently approved by the FDA for treating adults but not children. Adding the drugs to a standard chemotherapy in infants or children may improve disease response but could also cause additional side effects.
The study will examine treatment related side effects for up to 5 months. The time until disease progression and minimal residual disease (few cancer cells remain after treatment) will also be studied.
Who are they looking for?
This trial is searching for 50 newly diagnosed infants (under a year old) with ALL who have received limited or no prior therapy. Limited prior therapy includes systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal (into the spinal cord) chemotherapy.
How will it work
The patient will receive induction (to achieve remission), consolidation treatment (to kill any remaining cancer cells), and maintenance therapy (to prevent cancer from coming back). Bortezomib and vorinostat will be added to standard chemotherapy combinations.
Patients will be followed for up to 12 years after the start of treatment.
