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A Pilot Study of Dose Intensification of Methotrexate and Cyclophosphamide in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Non-Hodgkins Lymphoma and B-Cell All- A Limited Institution Phase III Pilot Study


Phase 1
N/A
21 Years
Open (Enrolling)
Both
Leukemia, Lymphoma

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Trial Information

A Pilot Study of Dose Intensification of Methotrexate and Cyclophosphamide in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Non-Hodgkins Lymphoma and B-Cell All- A Limited Institution Phase III Pilot Study


OBJECTIVES: I. Evaluate the feasibility and toxicity of dose intensification of methotrexate
and cyclophosphamide in patients with stage III or IV small, noncleaved cell non-Hodgkin's
lymphoma or B cell acute lymphoblastic leukemia. II. Estimate the response rate and survival
of these patients after this therapy.

OUTLINE: This is a two-stage study. Patients will receive cytarabine either by continuous
infusion (first stage) or bolus injection (second stage). Patients are stratified by disease
(stage III non-Hodgkin's lymphoma (NHL) vs stage IV NHL vs stage B acute lymphoblastic
leukemia). Therapy for all patients consists of alternating courses of "A" and "B". Patients
with stage III disease receive 4 courses of chemotherapy (ABAB) while those with stage IV
disease and B cell acute lymphoblastic leukemia receive 6 chemotherapy courses (ABABAB).
Course A - Induction: Patients receive intrathecal methotrexate (IT MTX) and intrathecal
cytarabine (IT Ara-C) on days 1, 4, and 11. Dexamethasone is administered by IV or orally
twice a day on days 1-5. Cyclophosphamide IV is administered every 12 hours on days 1-3.
Doxorubicin IV is administered over 15 minutes beginning 12 hours after the beginning of the
6th dose of cyclophosphamide (day 4). At the same time, vincristine IV is administered, then
repeated on day 11. Patients begin filgrastim (granulocyte colony-stimulating factor; G-CSF)
subcutaneously or IV over 30 minutes on day 5. Course B - Induction: The first 10 patients
enrolled receive cytarabine by continuous infusion while the second 10 patients enrolled
receive cytarabine by bolus IV. Patients begin treatment on day 18 and receive methotrexate
IV over 24 hours plus IT MTX during hour 1. Dexamethasone is administered by IV or orally
twice a day on days 1-5. After completing the 24 hour IV MTX infusion, patients begin
cytarabine by continuous infusion over 48 hours or bolus IV every 12 hours for 4 doses.
Patients receive G-CSF subcutaneously or IV over 30 minutes beginning on day 22. Patients
are assessed for remission status before day 36. Course A - Consolidation: Patients receive
dexamethasone IV or orally twice a day on days 1-5. IT MTX and IT Ara-C are administered on
days 1 and 4. Cyclophosphamide is administered as during Induction, with vincristine IV and
doxorubicin IV over 15 minutes 12 hours later. Vincristine repeats 1 week later. G-CSF
administration begins on day 5. Course B - Consolidation: Therapy begins on day 22 with
dexamethasone administered as previously. Methotrexate infusion and IT MTX are administered
as in Course B - Induction, as is cytarabine (either as a continuous infusion or bolus IV).
G-CSF is also administered as previously. Patients are followed monthly for the first 6
months, every 2 months for the next 6 months, then every 6 months for 3 years, then annually
thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 16 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Cytologically proven small, noncleaved cell non-Hodgkin's
lymphoma, Burkitt's lymphoma, non-Burkitt's lymphoma, or B cell acute lymphoblastic
leukemia (B-ALL) Stage III or IV B-ALL - must have FAB L3 morphology and have been
registered on POG-9400

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: HIV antibody positive allowed Not pregnant or lactating

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No
prior chemotherapy Endocrine therapy: Prior emergency steroid therapy may be allowed
Radiotherapy: Prior emergency radiotherapy may be allowed Surgery: Prior surgery allowed
Other: No concurrent dexamethasone as an anti-emetic

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Timothy C. Griffin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cook Children's Medical Center - Fort Worth

Authority:

United States: Federal Government

Study ID:

CDR0000066078

NCT ID:

NCT00003217

Start Date:

March 1998

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • childhood Burkitt lymphoma
  • untreated childhood acute lymphoblastic leukemia
  • B-cell childhood acute lymphoblastic leukemia
  • stage III childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Rochester Cancer CenterRochester, New York  14642
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Oklahoma Memorial HospitalOklahoma City, Oklahoma  73126-0307
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Hackensack University Medical CenterHackensack, New Jersey  07601
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Children's Memorial Hospital, ChicagoChicago, Illinois  60614