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Phase 2
20 Years
Open (Enrolling)

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Trial Information


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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed and previously untreated anaplastic
large cell Ki-1 lymphoma and T-cell large cell lymphoma Malignant lymphoblasts (identified
by immunophenotype) in pleural fluid, ascitic fluid, or bone marrow sufficient for
diagnosis Large cell lymphoma with T-cell phenotype eligible Localized mediastinal disease
and bone lymphoma eligible CNS disease eligible and defined as: Any clearly identifiable
tumor cells in cerebral spinal fluid Cranial nerve palsy (if not explained by extra
cranial tumor) Clinical Spinal Cord Compression Isolated intra cerebral mass No cranial
nerve palsies requiring immediate CNS irradiation

PATIENT CHARACTERISTICS: Age: Under 21 Performance status: Not specified Hematopoietic:
Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: Shortening
fraction greater than 27% on echocardiogram (ECHO) OR Left ventricular ejection fraction
greater than 47% on radionuclide scan (RCNA) OR Cardiac function assessed as within normal
limits by cardiologist ECHO or RCNA obtained as close as clinically possible to start of

PRIOR CONCURRENT THERAPY: No prior therapy except emergency treatment of airway
obstruction or superior vena cava syndrome No more than 72 hours between emergency
radiotherapy or steroids and initiation of protocol therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Minnie Abromowitch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Medical Center, Cincinnati


United States: Federal Government

Study ID:




Start Date:

July 1994

Completion Date:

Related Keywords:

  • Lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • stage IV childhood large cell lymphoma
  • Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Ireland Cancer Center Cleveland, Ohio  44106-5065
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Vanderbilt Cancer Center Nashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Huntsman Cancer Institute Salt Lake City, Utah  84112
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Herbert Irving Comprehensive Cancer Center New York, New York  10032
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Long Beach Memorial Medical Center Long Beach, California  90806
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital of Orange County Orange, California  92668
Children's Hospital of Denver Denver, Colorado  80218
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
St. Joseph's Hospital and Medical Center Paterson, New Jersey  07503
Children's Hospital Medical Center - Cincinnati Cincinnati, Ohio  45229-3039
Children's Hospital of Columbus Columbus, Ohio  43205-2696
Doernbecher Children's Hospital Portland, Oregon  97201-3098
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105