Trial Information

A PILOT STUDY FOR THE TREATMENT OF NEWLY-DIAGNOSED DISSEMINATED LYMPHOBLASTIC LYMPHOMA

OBJECTIVES: I. Estimate the toxicity and feasibility of intensifying the New York I (NYI)
regimen by adding etoposide and cytarabine, increasing the dose of methotrexate, using
pegaspargase, and compressing the treatment duration (11 months) in previously untreated
children with disseminated anaplastic (Ki-1 positive) large cell and large cell T-cell
lymphoma. II. Provide preliminary data for a future phase III study that will compare this
intensified regimen with the high-risk ALL regimen NYI in children with disseminated
lymphoblastic lymphoma. III. Continue to investigate the immunophenotype, cytogenetics, and
molecular biology of lymphoblastic lymphoma and their relationship to leukemia. IV. Obtain
preliminary data on treatment of anaplastic large cell (Ki-1) and T-cell large cell lymphoma
treated with intensive NYI.

OUTLINE: Patients with CNS disease at diagnosis receive craniospinal irradiation on Regimen
A at the conclusion of Maintenance chemotherapy. The following acronyms are used: ARA-C
Cytarabine, NSC-63878 CF Leucovorin calcium, NSC-3590 CTX Cyclophosphamide, NSC-26271 DNR
Daunorubicin, NSC-82151 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating
Factor (Amgen), NSC-614629 MTX Methotrexate, NSC-740 PEG-ASP Pegaspargase, NSC-624239 PRED
Prednisone, NSC-10023 TG Thioguanine, NSC-752 VCR Vincristine, NSC-67574 VP-16 Etoposide,
NSC-141540 Induction: 5-Drug Combination Systemic Chemotherapy with Hematopoietic
Stimulation plus 2-Drug Combination Intrathecal Chemotherapy. VCR/PRED/CTX/DNR/PEG-ASP; with
G-CSF; plus IT ARA-C/IT MTX. Consolidation: 7-Drug Combination Systemic Chemotherapy with
Hematopoietic Stimulation plus Single-Agent Intrathecal Chemotherapy.
VCR/PRED/PEG-ASP/VP-16/TG/ARA-C/MTX/CF; with G-CSF; plus IT MTX. Maintenance: Sequential
Pulses of 2-, 3-, 3-, and 2-Drug Systemic Chemotherapy Combinations plus Single-Agent
Intrathecal Chemotherapy. CTX/TG/IT MTX; VCR/PRED/DOX; VCR/MTX/CF/PEG-ASP; ARA-C/VP-16.
Regimen A: Radiotherapy. Craniospinal irradiation using megavoltage equipment.

PROJECTED ACCRUAL: 40 patients will be entered over approximately 10 months. If 4 or more
toxic deaths occur in the first 15 patients or 5 or more toxic deaths occur in the first 30
patients, accrual will stop. As of 05/96, asparaginase has been replaced with pegaspargase;
15-25 additional patients will be accrued. As of 01/97, a maximum of 35 patients will be
accrued for PEG asparaginase-containing treatment regimen. As of 5/97, this study is open
only to patients with anaplastic large cell and T cell large cell lymphoma. Approximately
60-90 patients will be accrued.