Phase I/II Trial of VELCADE® (Bortezomib) in Combination With Mitoxantrone and Etoposide for Relapsed or Refractory Acute Leukemias
VELCADE is a drug that blocks growth of cancer cells and helps destroy them. This research
will help us to determine if VELCADE when combined with chemotherapy is useful in treating
the leukemia with which you have been diagnosed. Your leukemia is a type that did not
respond to chemotherapy or has come back after successful therapy.
VELCADE is approved by the Food and Drug Administration (FDA) for the treatment of multiple
myeloma for patients that have received at least one prior therapy. Multiple Myeloma is a
type of cancer that develops from blood cells. The dose of the drug being used in this
research study is the same as what is used for the treatment of myeloma but the number of
injections is less. VELCADE has, however not been approved by the FDA for use in acute
leukemia. Mitoxantrone and etoposide, the other two chemotherapy drugs are also used for
In the first part of the study, we are going to test the safety of VELCADE at different
doses when given with mitoxantrone and etoposide. You may be enrolled at any one of three
doses. In the second part, we are going to assess the response to the combination of VELCADE
and chemotherapy drugs. You will receive VELCADE at the chosen dose based on safety
assessment from Phase I. It will be administered as an intravenous (through the vein)
injection on day-1 and day-4 of the 5-day schedule. In addition, you will also receive
mitoxantrone over 15 minutes and etoposide over 45 minutes from days 1-5. The first 28
days from the beginning of the treatment will be called a treatment cycle.
On day-14 of the treatment cycle, you will have a bone marrow biopsy done to see if all the
leukemia cells have disappeared. If there is no evidence of leukemia, then you may receive
growth factors to help your marrow recover faster. If there is still presence of leukemia,
in the same amount or more, then the treatment will be considered a failure and you will not
receive any more of this treatment.
If there is a partial improvement then you will receive additional cycles of VELCADE with
chemotherapy as described above until there are no signs of your disease. This is called a
Therapy will be withheld at any time if there is concern that you are having side-effects
that are not medically acceptable. Once the side-effects have resolved, VELCADE therapy may
be re-started at a lower dose.
It is estimated that you may require about two to three cycles of therapy.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Joanne Filicko-O'Hara, MD
Thomas Jefferson University
United States: Institutional Review Board
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