T2012-002: A Pilot Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination with Chemotherapy for Children, Adolescents, and Young Adults with Relapse of Acute Lymphoblastic Leukemia (IND 128316)
Study Chair: Nirali N. Shah, MD, MHS– National Cancer Institute, Pediatric Oncology Branch
Vice Chair: Alan S. Wayne, MD – Children’s Hospital Los Angeles
This study is permanently closed to accrual.
What is this study about:
This study is for patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL), mixed phenotypic acute leukemia and lymphoblastic lymphoma.
This is a study of a drug called Marqibo® in combination with intensive cytotoxic chemotherapy consisting of mitoxantrone, PEG-asparaginase, and dexamethasone. Methotrexate will also be given to help treat leukemia in the central nervous system. Marqibo® is a new formulation of a type of chemotherapy called vincristine. It is considered experimental because it has not been used in combination with mitoxantrone, PEG-asparaginase and dexamethasone. We are using Marqibo® in this new study because it seems to work against cancer in cells and animals. Marqibo® has been used in only a small number of adults and children and there is a lot that we do not know about it yet.
This is a phase I study. In a phase I study, drugs are tested to the highest dose that can be safely given. Drugs are given at gradually increasing dosages until there are unacceptable side effects. The goal of the Phase I study is to find out the dose of Marqibo® that can be safely given with mitoxantrone, PEG-asparaginase, and dexamethasone to children with relapsed ALL.
Marqibo® will also be studied with less intensive chemotherapy regimens to try to learn how safe Marqibo® is with other chemotherapy combinations.
18 to 36 children and young adults will participate in this study.
Why is this study being done:
The goals of this study are:
Criteria that need to be met to participate in this study: (Abbreviated List)
Patients cannot participate in the study if: (Abbreviated List)
Treatment:
If the exams, tests and procedures show that it is safe for you to be enrolled on the study, and you choose to take part, you will be assigned to Group A, Group B or Group C and receive the following drugs as a single course of therapy:
Group A
Drug |
Days |
Dose |
Marqibo® |
1, 8, 15 and 22 |
As assigned, IV |
Dexamethasone |
1-5 and 15-19 |
20 mg/m2/day , oral twice per day |
Mitoxantrone |
1 and 2 |
10 mg/m2/day IV |
PEG-Asparaginase** |
3 and 17 |
2500 mg/m2 IM or IV |
Methotrexate IT |
1 and 8 |
IT dose depends on age |
**Erwinia asparaginase, Erwinia Chyrsanthemi, asparaginase Erwinia chrysanthemi (recombinant)-rwyn or crisantapase can be substituted for patients only in the setting of allergt to PEG-asparaginase.
|
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 8 |
Day 1
|