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

Swiss Group for Clinical Cancer Research

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: gemcitabine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00234026

SAKK 36/03

EU-20523

Details and patient eligibility

About

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.

Full 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 lymphoma.

Secondary

• Determine the time to progression and time to treatment failure in patients treated with this drug.
• Determine the response duration in patients treated with this drug.
• Determine the adverse reactions in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 2 years.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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