Pilot Study Of Sirolimus Plus Multiagent Chemotherapy For Relapsed/Refractory Acute Lymphoblastic Leukemia/Lymphoma
You will receive the drug sirolimus in addition to standard chemotherapy drugs.
Just like your original cancer treatment, relapsed leukemia/lymphoma treatment is divided
into different parts. You will get sirolimus during the first two parts:
1. Re-induction: We give chemotherapy drugs to try to put your cancer back into remission,
meaning that no cancer cells are found in the bone marrow samples (if you have
leukemia) or on imaging studies (if you have lymphoma). From start to finish, this part
of therapy lasts 35 days. On this study, you will take the drug sirolimus daily in
addition to the normal re-induction chemotherapy drugs. You will swallow liquid
sirolimus and you must take it with food. You will take sirolimus three times on the
first day and two times each day after that during re-induction.
Altogether, this is the schedule for re-induction:
- Sirolimus by mouth starting 7 days before standard re-induction starts, and
continuing every day through day 28
- Mitoxantrone by vein on days 1 and 2
- Vincristine by vein on days 3, 10, 17 and 24
- Dexamethasone by vein or by mouth on days 1-5 and 15-19
- PEG-asparaginase* on days 3 and 17
- IT Methotrexate given in spinal fluid on day 1 (all patients) day 8,29 (if no
cancer found in spinal fluid)
- IT Triples given in spinal fluid on days 8,15,22,29 (if cancer found in spinal
fluid)
(If you have an allergic reaction to PEG-asparaginase, you may be given 6 doses of
Erwinia L-asparaginase instead)
2. Consolidation: We give drugs to continue to kill cancer cells in your body and prevent
them from coming back. From start to finish, this part of therapy will last 63 days (it
could be longer if we have to interrupt your treatment because you have low blood
counts, and you need to wait for them to come up). On this study, you will take the
drug sirolimus daily in addition to the normal consolidation chemotherapy drugs. You
will take sirolimus three times on the first day and two times each day after that
during consolidation.
Altogether, this is the schedule for consolidation:
- Sirolimus by mouth starting 7 days before consolidation starts, and continuing
every day through day 56.
- Cyclophosphamide by vein on days 1 and 29
- Cytarabine by vein or under skin on days 1-4, 8-11, 29-32, 36-39
- 6-mercaptopurine by mouth on days 1-14, 29-42
- PEG-asparaginase* by vein on days 15 and 43
- Vincristine by vein on days 15 and 43
- It Methotrexate in spinal fluid on Days 1 and 29
3. After you complete re-induction and consolidation, your doctor will determine the next
steps of your treatment. This will depend on how you are doing and it will be up to you
and your doctor. It will not be part of this study.
This research only includes the re-induction and consolidation portions of treatment (1 and
2, above). If you have already done re-induction, you can enter the study for consolidation
only.
In addition to all the regular tests and procedures done to check on your cancer during this
study, we will also take additional blood samples to monitor the levels of sirolimus in your
blood (in order to adjust your dose) and we will also take blood samples to find certain
markers in your blood that might indicate that the sirolimus is doing what it is supposed to
do.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine rate of dose limiting toxicities
The safety of the regimen will be assessed by the occurrence of unexpected or severe adverse events attributable to sirolimus
35 days
Yes
Maureen O'Brien, MD
Principal Investigator
Children's Hospital Medical Center, Cincinnati
United States: Institutional Review Board
SIR-MO-1101
NCT01658007
August 2012
Name | Location |
---|---|
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |