Gemcitabine in Treating Patients With Newly Diagnosed, Relapsed, or Chemotherapy-Resistant Mantle Cell Lymphoma
This study has been completed.
Sponsor:
Swiss Group for Clinical Cancer Research
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
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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) |
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
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 | Kantonsspital St. Gallen |
| Principal Investigator: | Lucas Widmer, MD | City Hospital Triemli |
More Information
Publications:
Hitz F, Martinelli G, Zucca E, et al.: A multicentre phase II trial testing gemcitabine in the treatment of patients with newly diagnosed, relapsed or chemotherapy resistant mantle cell lymphoma: SAKK 36/03. [Abstract] Blood 110 (11): A-4454, 2007.
| 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 May 16, 2013