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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00234026
First received: October 5, 2005
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Objective response at end of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse reactions at end of study treatment [ Designated as safety issue: Yes ]
  • Time to progression [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]
  • Time to treatment failure at end of study treatment [ Designated as safety issue: No ]

Study Start Date: June 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234026

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

Publications:
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00234026     History of Changes
Other Study ID Numbers: SAKK 36/03, EU-20523
Study First Received: October 5, 2005
Last Updated: June 4, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
recurrent mantle cell lymphoma
stage I mantle cell lymphoma
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 20, 2014