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

Lymphoma Clinical Trial

Official title:

Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Gemcitabine for the Treatment of Patients With Newly Diagnosed, Relapsed or Chemotherapy Resistant Mantle Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234026
• Other study ID #: SAKK 36/03
• Secondary ID: EU-20523
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2005
• Last updated: June 4, 2012
• Start date: June 2005
• Est. completion date: March 2006

Study information

• Verified date: June 2012
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Drug:
• gemcitabine hydrochloride

Locations

Country	Name	City	State
Switzerland	Kantonspital Aarau	Aarau
Switzerland	Kantonsspital Baden	Baden
Switzerland	Oncology Institute of Southern Switzerland	Bellinzona
Switzerland	Spital Buelach	Bulach
Switzerland	Spital Limmattal	Schlieren
Switzerland	Kantonsspital - St. Gallen	St. Gallen
Switzerland	Spital Uster	Uster
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	City Hospital Triemli	Zurich
Switzerland	Klinik Hirslanden	Zurich
Switzerland	Onkozentrum - Klinik im Park	Zurich
Switzerland	Stadtspital Waid	Zurich
Switzerland	UniversitaetsSpital Zuerich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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 trea — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response at end of study treatment			No
Secondary	Adverse reactions at end of study treatment			Yes
Secondary	Time to progression			No
Secondary	Response duration			No
Secondary	Time to treatment failure at end of study treatment			No