|Secondary Protocol No.
||T2008-002 A Phase I Trial of NECTAR (Nelarabine, Etoposide, and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL and POIETIC
as of 10/02/2012 the title is:
T2008-002 A Phase I Trial of NECTAR (Nelarabine, Etoposide, and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL, POIETIC, and ITCC
||Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL.
||Nelarabine: Dose will be assigned at study entry. Nelarabine will be given IV over 60 minutes (given at hours 0 to 1) on days 1 through 5.
Etoposide: 100 mg/m2/day IV over 2 hours (given at hours 1 to 3) on days 1 through 5.
Cyclophosphamide: Dose will be assigned at study entry, IV as a 30-60 minute infusion (given at hours 3 to 4) on days 1 through 5.
||The study is designed to determine the maximum tolerated doses and dose-limiting toxicities (DLTs) of nelarabine, etoposide and cyclophosphamide when given in combination to children with T-ALL and bone marrow relapse or T-LL.
||Patients must have first relapse T-cell acute lymphocytic leukemia (ALL) or T-cell lymphoblastic lymphoma (LL).
|Applicable Disease Sites
||Acute Lymphocytic Leukemia (ALL)
||CYCLOPHOSPHAMIDE (CYTOXAN, NEOSAR)
FILGRASTIM (G-CSF, NEUPOGEN)
||Masonic Cancer Center : Michael Burke
||Patients must be between 1 and 21 years of age and have at least 6 weeks elapsed from administration of nitrosureas and at least 12 weeks since administration of craniospinal or hemipelvic radiation. Those of child-bearing potention must agree to use effective method of contraception during study and for a minimum of 6 months after treatment. Women who are nursing or pregnant are not eligible. Must have adequate renal function. Patients who had a previous hematopoietic stem cell transplant, history of prior veno-occlusive disease, or prior seizsure disorder requiring anti-convulsant therapy are not eligible. A signed informed consent (assent form) and HIPAA authorization are required.