Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

Swiss Cancer Institute

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 pha...

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 lympho...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 1 2005

    Trial Type :

    INTERVENTIONAL

    End Date :

    March 1 2006

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00234026

    Start Date

    June 1 2005

    End Date

    March 1 2006

    Last Update

    June 5 2012

    Active Locations (16)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (16 locations)

    1

    Kantonspital Aarau

    Aarau, Switzerland, 5001

    2

    Baden, Switzerland, 5404

    3

    Kantonsspital Baden

    Baden, Switzerland, CH-5404

    4

    Oncology Institute of Southern Switzerland

    Bellinzona, Switzerland, 6500