A PHASE II TRIAL OF 2-CDA IN PREVIOUSLY TREATED OR UNTREATED PATIENTS WITH MANTLE CELL LYMPHOMA (MCL)
18 Years
N/A
Both
Lymphoma
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 Center | Rochester, Minnesota 55905 |
| CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| CentraCare Clinic | Saint Cloud, Minnesota 56303 |
| Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota 58501 |
| CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
| Altru Health Systems | Grand Forks, North Dakota 58201 |
| CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
| CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
