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Cladribine in Patients With Mantle Cell Lymphoma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002879
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effects of cladribine in previously treated or untreated patients with mantle cell lymphoma.


Condition Intervention Phase
Lymphoma
Drug: cladribine
Phase II

MedlinePlus related topics:   Cancer    Lymphoma   

ChemIDplus related topics:   Cladribine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A PHASE II TRIAL OF 2-CDA IN PREVIOUSLY TREATED OR UNTREATED PATIENTS WITH MANTLE CELL LYMPHOMA (MCL)

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   48
Study Start Date:   November 1996

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002879

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program    
      Scottsdale, Arizona, United States, 85259-5404
United States, Illinois
CCOP - Carle Cancer Center    
      Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association    
      Peoria, Illinois, United States, 61602
United States, Iowa
CCOP - Cedar Rapids Oncology Project    
      Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association    
      Des Moines, Iowa, United States, 10309-1016
Siouxland Hematology-Oncology    
      Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita    
      Wichita, Kansas, United States, 67214-3882
United States, Louisiana
CCOP - Ochsner    
      New Orleans, Louisiana, United States, 70121
United States, Michigan
CCOP - Ann Arbor Regional    
      Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Duluth    
      Duluth, Minnesota, United States, 55805
CentraCare Clinic    
      Saint Cloud, Minnesota, United States, 56303
Mayo Clinic Cancer Center    
      Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium    
      Omaha, Nebraska, United States, 68131
United States, North Dakota
Altru Health Systems    
      Grand Forks, North Dakota, United States, 58201
CCOP - Merit Care Hospital    
      Fargo, North Dakota, United States, 58122
Quain & Ramstad Clinic, P.C.    
      Bismarck, North Dakota, United States, 58501
United States, Ohio
CCOP - Toledo Community Hospital Oncology Program    
      Toledo, Ohio, United States, 43623-3456
United States, Pennsylvania
CCOP - Geisinger Clinical and Medical Center    
      Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
CCOP - Sioux Community Cancer Consortium    
      Sioux Falls, South Dakota, United States, 57105-1080
Rapid City Regional Hospital    
      Rapid City, South Dakota, United States, 57709
Canada, Saskatchewan
Saskatchewan Cancer Agency    
      Regina, Saskatchewan, Canada, S4S 6X3

Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)

Investigators
Study Chair:     David J. Inwards, MD     Mayo Clinic    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Inwards D, Brown D, Fonseca R, et al.: NCCTG Phase II trial of 2-chlorodeoxyadenosine (2-CDA) as initial therapy for mantle cell lymphoma. A well-tolerated treatment with promising activity. Blood 94(10 suppl 1): A-2930, 660a, 1999.

Other Publications:

Study ID Numbers:   CDR0000065179, NCCTG-958053
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002879
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Cladribine
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Mantle cell lymphoma
Lymphoma
Recurrence
2-chloro-3'-deoxyadenosine

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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