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

NCT ID: NCT00234026

Last Updated: 2012-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2006-03-31

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

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 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.

Conditions

Lymphoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felicitas Hitz, MD

Role: STUDY_CHAIR

Cantonal Hospital of St. Gallen

Lucas Widmer, MD

Role: PRINCIPAL_INVESTIGATOR

City Hospital Triemli

Locations

Kantonspital Aarau

Aarau, , Switzerland

Baden, , Switzerland

Kantonsspital Baden

Baden, , Switzerland

Oncology Institute of Southern Switzerland

Bellinzona, , Switzerland

Spital Buelach

Bülach, , Switzerland

Kantonsspital - St. Gallen

Sankt Gallen, , Switzerland

Spital Limmattal

Schlieren, , Switzerland

Spital Uster

Uster, , Switzerland

Kantonsspital Winterthur

Winterthur, , Switzerland

Zurich, , Switzerland

Onkozentrum - Klinik im Park

Zurich, , Switzerland

City Hospital Triemli

Zurich, , Switzerland

Klinik Hirslanden

Zurich, , Switzerland

Stadtspital Waid

Zurich, , Switzerland

Zurich, , Switzerland

UniversitaetsSpital Zuerich

Zurich, , Switzerland

Countries

Switzerland

References

Hitz F, Martinelli G, Zucca E, von Moos R, Mingrone W, Simcock M, Peterson J, Cogliatti SB, Bertoni F, Zimmermann DR, Ghielmini M; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland. A multicentre phase II trial of gemcitabine for the treatment of patients with newly diagnosed, relapsed or chemotherapy resistant mantle cell lymphoma: SAKK 36/03. Hematol Oncol. 2009 Sep;27(3):154-9. doi: 10.1002/hon.891.

Reference Type: RESULT

PMID: 19274614 (View on PubMed)

Other Identifiers

EU-20523

Identifier Type: -

Identifier Source: secondary_id

SAKK 36/03

Identifier Type: -

Identifier Source: org_study_id