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Title:

A Phase II Pilot Trial of Bortezomib (PS-341, Velcadeï¿¢, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

Protocol Number:

PAALL07P1

Phase:

Phase II

Physician:

Patrick Brown

Purpose:

This phase II trial is studying the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or acute lymphoblastic lymphoma.

Eligibility:

Ages Eligible for Study: 1 Year to 31 Years DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Pre-B acute lymphoblastic leukemia (ALL) in first early ( less than 36 months from diagnosis) isolated bone marrow or combined bone marrow/extramedullary relapse as documented by histology and immunophenotyping T-cell ALL in first isolated bone marrow or combined relapse as documented by histology and immunophenotyping T-cell acute lymphoblastic lymphoma in first relapse as documented by histology Measurable disease as documented by clinical, radiographic, or histologic criteria Relapsed or refractory to conventional therapy No Ph+ ALL unless refractory to â?¥ 1 tyrosine kinase inhibitor therapy Patients who are unable to tolerate tyrosine kinase inhibitor therapy due to toxicity are eligible No mature B-cell ALL (i.e., sIg positive and kappa or lambda restricted positivity) with FAB L3 morphology and/or myc translocation No known optic nerve and/or retinal involvement Patients presenting with visual disturbances should have an ophthalmological exam and, if indicated, an MRI to determine optic nerve or retinal involvement No extramedullary disease (i.e., isolated CNS disease or isolated testicular disease) No concurrent genetic syndrome (e.g., Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome)

Treatment:

Reinduction block 1: Patients receive cytarabine intrathecally (IT) on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; doxorubicin hydrochloride IV over 15 minutes on day 1; oral prednisone twice daily on days 1-29; bortezomib IV on days 1, 4, 8, and 11; and pegaspargase intramuscularly (IM) on days 2, 8, 15, and 22. Patients with CNS-negative disease (CNS1 or CNS2) also receive methotrexate IT on days 15 and 29; patients with CNS-positive disease (CNS3) receive triple intrathecal therapy (TIT) comprising methotrexate, hydrocortisone, and cytarabine IT on days 8, 15, 22, and 29. After completion of reinduction block 1, patients with acute lymphoblastic leukemia (ALL) and M2 or M3 bone marrow proceed directly to reinduction block 2. Patients with ALL and M1 bone marrow or acute lymphoblastic lymphoma proceed to reinduction block 2 after blood counts recover. Patients with persistent CSF blasts after 6 doses of TIT or patients with progressive acute lymphoblastic lymphoma are removed from the study. Reinduction block 2: Patients receive etoposide phosphate IV over 1-2 hours on days 1-5; cyclophosphamide IV over 1 hour on days 1-5; bortezomib IV on days 1, 4, and 8; filgrastim (G-CSF) subcutaneously (SC) or IV daily beginning on day 6 and continuing until blood counts recover*; high-dose methotrexate IV on day 22; and leucovorin calcium orally or IV every 6 hours on days 23 and 24. Patients with CNS-negative disease also receive methotrexate IT on days 1 and 22; patients with CNS-positive disease receive TIT on days 1 and 22. After completion of reinduction block 2, patients proceed to reinduction block 3 immediately or when blood counts recover. Patients with disease progression are removed from the study. NOTE: *Patients do not receive G-CSF on day 8. Reinduction block 3: Patients receive cytarabine IV over 3 hours twice daily on days 1, 2, 8, and 9; L-asparaginase IM on days 2 and 9; and G-CSF SC or IV daily beginning on day 10 and continuing until blood counts recover. After completion of study treatment, patients are followed every 6 months for 3 years and then annually for 2 years.

Population:

Pediatric

Last Update

05/24/2013 04:02 AM

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