Status:
COMPLETED
Gemcitabine in Treating Patients With Newly Diagnosed, Relapsed, or Chemotherapy-Resistant Mantle Cell Lymphoma
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This pha...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of gemcitabine, in terms of objective response and tolerability, in patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lympho...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed mantle cell lymphoma meeting 1 of the following criteria:
- Newly diagnosed
- Chemotherapy resistant
- Relapsed disease after no more than 2 prior lines of chemotherapy
- Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 11 mm by CT scan
- No prior or current CNS lymphoma or lymphomatous meningosis
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- WHO 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Neutrophil count ≥ 1,500/mm\^3 (1,000/mm\^3 in case of bone marrow infiltration)
- Platelet count ≥ 100,000/mm\^3 (75,000/mm\^3 in case of bone marrow infiltration)
- Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2 times ULN
- AST and ALT ≤ 2 times ULN
- No active hepatitis
- Renal
- Creatinine clearance ≥ 50 mL/min
- Cardiovascular
- No congestive heart failure
- No New York Heart Association class III or IV heart disease
- No unstable angina pectoris
- No significant cardiac arrhythmia or arrhythmia requiring chronic treatment
- No myocardial infarction within the past 3 months
- Immunologic
- No active autoimmune disease
- No ongoing infection (e.g., HIV)
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after study participation
- No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
- No uncontrolled diabetes mellitus
- No gastric ulcers
- No other uncontrolled medical condition that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent thalidomide
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- Not specified
- Radiotherapy
- Prior radiotherapy allowed provided indicator lesions were not in the irradiated field
- No concurrent radiotherapy to the lungs or mediastinum
- Surgery
- Not specified
- Other
- More than 30 days since prior systemic anticancer treatment
- More than 30 days since prior clinical trial participation
- No other concurrent anticancer drugs
- No other concurrent experimental drugs
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00234026
Start Date
June 1 2005
End Date
March 1 2006
Last Update
June 5 2012
Active Locations (16)
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1
Kantonspital Aarau
Aarau, Switzerland, 5001
2
Baden, Switzerland, 5404
3
Kantonsspital Baden
Baden, Switzerland, CH-5404
4
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, 6500