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


Phase 2
N/A
20 Years
Open (Enrolling)
Both
Lymphoma

Thank you

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.

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
therapy

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:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Minnie Abromowitch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Medical Center, Cincinnati

Authority:

United States: Federal Government

Study ID:

CDR0000063751

NCT ID:

NCT00002590

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Ireland Cancer CenterCleveland, Ohio  44106-5065
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of DenverDenver, Colorado  80218
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105