Gemcitabine in Treating Patients With Newly Diagnosed, Relapsed, or Chemotherapy-Resistant Mantle Cell Lymphoma

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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 phase II trial is studying how well gemcitabine works in treating patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Gemcitabine

Criteria

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