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

June 4, 2012 updated by: Swiss Group for Clinical Cancer Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonspital Aarau
      • Baden, Switzerland, CH-5404
        • Kantonsspital Baden
      • Baden, Switzerland, 5404
      • Bellinzona, Switzerland, 6500
        • Oncology Institute of Southern Switzerland
      • Bulach, Switzerland, CH-8180
        • Spital Buelach
      • Schlieren, Switzerland, 8952
        • Spital Limmattal
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen
      • Uster, Switzerland, 8610
        • Spital Uster
      • Winterthur, Switzerland, CH-8400
        • Kantonsspital Winterthur
      • Zurich, Switzerland, CH-8091
        • Universitaetsspital Zuerich
      • Zurich, Switzerland, 8002
        • Onkozentrum - Klinik im Park
      • Zurich, Switzerland, 8001
      • Zurich, Switzerland, 8063
        • City Hospital Triemli
      • Zurich, Switzerland, CH-8008
        • Klinik Hirslanden
      • Zurich, Switzerland, CH-8037
        • Stadtspital Waid
      • Zurich, Switzerland, CH-8044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective response at end of study treatment

Secondary Outcome Measures

Outcome Measure
Time to progression
Response duration
Adverse reactions at end of study treatment
Time to treatment failure at end of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Group for Clinical Cancer Research

Investigators

  • Study Chair: Felicitas Hitz, MD, Cantonal Hospital of St. Gallen
  • Principal Investigator: Lucas Widmer, MD, City Hospital Triemli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

October 5, 2005

First Submitted That Met QC Criteria

October 5, 2005

First Posted (Estimate)

October 6, 2005

Study Record Updates

Last Update Posted (Estimate)

June 5, 2012

Last Update Submitted That Met QC Criteria

June 4, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAKK 36/03
  • EU-20523

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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