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Phase II Trial of Intensive, Short-Course Combination Chemotherapy in the Treatment of Newly Diagnosed Patients With Poor-Risk Nonlymphoblastic Lymphoma and Acute B-Lymphoblastic Leukemia and in Patients With Recurrent Non-Hodgkin's Lymphoma


Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

Trial Information

Phase II Trial of Intensive, Short-Course Combination Chemotherapy in the Treatment of Newly Diagnosed Patients With Poor-Risk Nonlymphoblastic Lymphoma and Acute B-Lymphoblastic Leukemia and in Patients With Recurrent Non-Hodgkin's Lymphoma


OBJECTIVES: I. Improve the survival of children and adolescents with poor-risk
nonlymphoblastic lymphoma and acute B-lymphoblastic leukemia using an intensive,
short-course regimen of combination chemotherapy. II. Assess the toxicity of the regimen.

OUTLINE: Nonrandomized study. Induction: 7-Drug Combination Chemotherapy with Leucovorin
Rescue plus Triple Intrathecal Therapy (TIT). Cyclophosphamide, CTX, NSC-26271; Thiotepa,
TSPA, NSC-6396; Vincristine, VCR, NSC-67574; Daunorubicin, DNR, NSC-82151; Dexamethasone,
DM, NSC-34521; Etoposide, VP-16, NSC-141540; Methotrexate, MTX, NSC-740; with Leucovorin
calcium, Citrovorum Factor, CF, NSC-3590; plus TIT: IT MTX; IT Cytarabine, IT ARA-C,
NSC-63878; IT Hydrocortisone, IT HC, NSC-10483. Consolidation: 6-Drug Combination
Chemotherapy with Leucovorin Rescue plus TIT. ARA-C; VP-16; Asparaginase (E. coli), ASP,
NSC-109229; MTX; VCR; Methylprednisolone, MePRDL, NSC-19987; with CF; plus TIT. Reinduction:
7-Drug Combination Chemotherapy with Leucovorin Rescue plus TIT. CTX; TSPA; VCR; DNR; DM;
VP-16; MTX; with CF; plus TIT.

PROJECTED ACCRUAL: A maximum of 30 patients, accrued from 4 institutions, will be entered.
If at any time more than 3 patients are not "event free", the trial will be terminated
early, with patients considered event free if they enter remission, do not die as a result
of treatment toxicity, and do not experience progression within 1 year from the start of
therapy.

Inclusion Criteria


DISEASE CHARACTERISTICS: Newly diagnosed undifferentiated nonlymphoblastic non-Hodgkin's
lymphoma (Burkitt's or non-Burkitt's) Newly diagnosed large cell lymphoma with CNS
involvement Recurrent non-Hodgkin's lymphoma L-3 and B-cell leukemia included At least 1
of the following required: LDH at least 500 IU/liter (old method) or 2,000 IU/liter (new
method) Bone marrow involvement (greater than 5% lymphoblasts) CNS involvement
(lymphoblasts on CSF cytospin or intracranial mass on CT or MRI scan)

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Hematopoietic: Not
specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Prior therapy allowed for non-Hodgkin's lymphoma No prior
therapy for all other diseases

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Norma Wollner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

90-013

NCT ID:

NCT00002471

Start Date:

February 1990

Completion Date:

January 2003

Related Keywords:

  • Leukemia
  • Lymphoma
  • childhood Burkitt lymphoma
  • L3 childhood acute lymphoblastic leukemia
  • B-cell childhood acute lymphoblastic leukemia
  • L3 adult acute lymphoblastic leukemia
  • B-cell adult acute lymphoblastic leukemia
  • recurrent adult non-Hodgkin lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult Burkitt lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • stage IV childhood large cell lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Kaplan Cancer Center New York, New York  10016
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104