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HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR DIFFUSE SMALL NONCLEAVED CELL LYMPHOMA AND THE L-3 SUBTYPE OF ALL: A PILOT STUDY OF A MULTIDRUG REGIMEN


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

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Trial Information

HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR DIFFUSE SMALL NONCLEAVED CELL LYMPHOMA AND THE L-3 SUBTYPE OF ALL: A PILOT STUDY OF A MULTIDRUG REGIMEN


OBJECTIVES: I. Determine the response rate and disease free survival of HIV seronegative
patients with diffuse small noncleaved cell lymphoma or L3 acute lymphocytic leukemia when
treated with high intensity, brief duration combination chemotherapy: alternating courses of
ifosfamide/cytarabine/etoposide and cyclophosphamide/doxorubicin, each with
methotrexate/vincristine/dexamethasone. II. Determine the toxicity of these regimens in HIV
negative patients.

OUTLINE: Patients are stratified by participating institution and disease type (diffuse
small noncleaved cell lymphoma vs L3 ALL). Patients receive cyclophosphamide IV over 5-10
minutes on days 1 through 5 and oral prednisone on days 1 through 7, followed by alternating
courses of: 2) ifosfamide IV over 1 hour on days 8 through 12, methotrexate IV over 24 hours
on day 8; leucovorin calcium IV over 36 hours after initiation of methotrexate, then IV (or
orally as tolerated, after the first 24 hours) every 6 hours until the serum methotrexate
level is below 5 x 10 to the minus eighth M; vincristine IV on day 8; cytarabine IV over 48
hours and etoposide IV over 60 minutes on days 11 and 12; and oral dexamethasone on days 8
through 12, plus triple intrathecal therapy (TIT) with methotrexate, cytarabine, and
hydrocortisone on days 8 and 12, and 3) cyclophosphamide IV over 5-10 minutes on days 29
through 33; methotrexate IV over 24 hours and vincristine IV on day 29; leucovorin calcium
IV over 36 hours after initiation of methotrexate, then IV (or orally as tolerated, after
the first 24 hours) every 6 hours until the serum methotrexate level is below 5 x 10 to the
minus eighth M; doxorubicin IV on days 32 and 33; and oral dexamethasone on days 29 through
33, plus TIT on day 29, with doses as above. Patients with CNS disease at diagnosis continue
TIT once weekly until the CSF clears, then weekly for 4 more weeks. TIT must be completed
prior to initiation of radiotherapy. All patients must complete at least the first 3 courses
of chemotherapy. Courses 2 and 3 each repeat 3 times in the absence of disease progression
or unacceptable toxicity. On days 134-139, patients who have had prior bone marrow
involvement receive cranial radiation therapy. Patients who achieve less than a complete
response and who have an HLA-matched sibling should undergo allogeneic bone marrow
transplant on protocol CLB-9113. Patients are followed monthly for 6 months, every 2 months
for 18 months, every 6 months for 2 years, and thereafter for survival.

PROJECTED ACCRUAL: A total of 26-45 lymphoma patients and 2-6 leukemia patients will be
accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically documented diffuse small noncleaved cell lymphoma
(category J by IWF) of any stage Nodal or abdominal masses with less than 25% lymphoblasts
in marrow are defined as lymphoma OR Histologically documented L3 acute lymphocytic
leukemia (ALL) Greater than 25% lymphoblasts in marrow is defined as ALL, regardless of
presence of bulky nodal disease Lymphoma requirements include: Documentation of
lymphadenopathy, splenomegaly, or hepatomegaly, presence or absence of abdominal masses,
and presence or absence of B symptoms Measurable disease other than ascites and pleural
effusions, bony disease, and CNS lesions Bidimensionally measurable mass on physical exam,
x-ray, or CT, or MRI OR Clearly defined hepatic mass greater than 3.5 cm on CT, MRI, or
ultrasound considered to represent lymphoma OR Histologically documented hepatic lymphoma
with the liver extending more than 5 cm below the costal margin on quiet respiration ALL
requirements include: Documentation of monoclonal surface immunoglobulin by surface
immunophenotyping Lymph node biopsy strongly recommended for patients with obvious marrow
involvement Disease labeled L3 but also manifested by lymphadenopathy must be evaluated as
is lymphoma (see above)

PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Any status Life expectancy:
At least 2 years Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times
normal (unless further elevation is directly attributable to malignancy) Renal: Creatinine
no greater than 1.5 times normal (unless further elevation is directly attributable to
malignancy) Cardiovascular: No uncontrolled or severe cardiovascular disease, e.g.: No
myocardial infarction within the past 6 months No congestive heart failure Other: HIV
negative No active, uncontrolled bacterial, viral, or fungal infection No active,
uncontrolled duodenal ulcer No other serious medical illness No serious psychiatric
condition that would preclude informed consent or protocol compliance No second malignancy
within 5 years except: Curatively treated carcinoma in situ of the cervix Curatively
treated basal cell carcinoma Not pregnant Effective contraception required of fertile
patients

PRIOR CONCURRENT THERAPY: Biologic: No concurrent growth factors Chemotherapy: Not
specified Endocrine therapy: Not specified Radiotherapy: No concurrent palliative
radiotherapy Surgery: Not specified Other: No prior therapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Edward J. Lee, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Central Maryland Oncology Center

Authority:

United States: Federal Government

Study ID:

CDR0000077643

NCT ID:

NCT00002494

Start Date:

May 1992

Completion Date:

January 2006

Related Keywords:

  • Leukemia
  • Lymphoma
  • untreated adult acute lymphoblastic leukemia
  • L3 adult acute lymphoblastic leukemia
  • stage I adult Burkitt lymphoma
  • stage II adult Burkitt lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV adult Burkitt lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Rhode Island HospitalProvidence, Rhode Island  02903
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037