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A PHASE II TRIAL OF 2-CDA IN PREVIOUSLY TREATED OR UNTREATED PATIENTS WITH MANTLE CELL LYMPHOMA (MCL)


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A PHASE II TRIAL OF 2-CDA IN PREVIOUSLY TREATED OR UNTREATED PATIENTS WITH MANTLE CELL LYMPHOMA (MCL)


OBJECTIVES: I. Determine the efficacy of cladribine (2-chlorodeoxyadenosine; 2-CdA) as
treatment for mantle cell lymphoma (MCL) either as initial therapy or for
relapsed/refractory disease. II. Determine by flow cytometry immunophenotyping of blood
lymphocytes the number of patients with peripheral blood involvement at the time of
diagnosis and compare the presence or absence of peripheral blood involvement with response
data. III. Detect rearrangements involving the bcl-1 gene and immunoglobulin heavy chain
locus by molecular techniques (e.g., polymerase chain reaction, Southern blotting, or in
situ hybridization), and compare these results with immunohistochemical demonstration of
bcl-1 protein expression. VI. Determine the proliferative rate of MCL by
immunohistochemistry and DNA content flow cytometry. V. Summarize the toxic effects
associated with this treatment.

OUTLINE: Patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) daily for 5 days every
4 weeks for a maximum of 6 courses; response is assessed after every 2 courses. Patients in
complete remission or with stable disease discontinue treatment and are followed; those with
disease progression at any time are removed from study. Patients are followed every 2 months
for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually for 2 years.

PROJECTED ACCRUAL: Up to 25 previously treated patients will be entered over approximately 3
years if there is at least 1 response in the first 11 patients. Up to 23 previously
untreated patients will be entered over approximately 3 years if there are at least 4
responses in the first 13 patients.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed mantle cell lymphoma (MCL) requiring
therapy NCCTG pathology review required - Repeat biopsy is required for previously treated
patients with previously biopsy proven MCL who relapse after achieving a partial or
complete remission - Rebiopsy is not required for patients with: Progression of previously
biopsy proven MCL who have not received therapy since the diagnostic biopsy OR Previously
biopsy proven MCL who progress or achieve less than a partial remission following initial
therapy Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin normal AST no greater than 3 times normal (5 times
normal with liver involvement) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular:
No uncontrolled hypertension No unstable angina No active congestive heart failure No
myocardial infarction within 6 months No serious uncontrolled arrhythmia Other: No active
or uncontrolled infection No HIV antibody No medical or psychiatric condition that
precludes participation No malignancy in the past 5 years, except carcinoma in situ of the
cervix, resected basal cell or squamous cell carcinomas of the skin, or prostate cancer
that is in remission following a radical retropubic prostatectomy or radiation therapy No
pregnant or nursing women Negative pregnancy test required of fertile women within 7 days
prior to entry Effective contraception required of fertile patients throughout study and
at least 30 days thereafter

PRIOR CONCURRENT THERAPY: Recovered from any reversible acute toxic effects of previous
therapy Biologic therapy: Not specified Chemotherapy: At least 4 weeks since chemotherapy
(8 weeks since nitrosoureas or mitomycin) No prior fludarabine, pentostatin, or cladribine
Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to greater than 25%
of bone marrow Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David J. Inwards, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000065179

NCT ID:

NCT00002879

Start Date:

November 1996

Completion Date:

Related Keywords:

  • Lymphoma
  • mantle cell lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CentraCare ClinicSaint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080