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

NCT00234026 | Completed Phase 2 DMC

• 2 other identifiers: SAKK 36/03EU-20523
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 16

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 phase II trial is studying how well gemcitabine works in treating patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lymphoma.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Objective response at end of study treatment

Secondary Outcomes (4)

• Adverse reactions at end of study treatment

• Time to progression

• Response duration

• Time to treatment failure at end of study treatment

Interventions

gemcitabine hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (16)

Kantonspital Aarau

Aarau, 5001, Switzerland

Location

Unknown Facility

Baden, 5404, Switzerland

Location

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

Oncology Institute of Southern Switzerland

Bellinzona, 6500, Switzerland

Location

Spital Buelach

Bülach, CH-8180, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Spital Limmattal

Schlieren, 8952, Switzerland

Location

Spital Uster

Uster, 8610, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8400, Switzerland

Location

Unknown Facility

Zurich, 8001, Switzerland

Location

Onkozentrum - Klinik im Park

Zurich, 8002, Switzerland

Location

City Hospital Triemli

Zurich, 8063, Switzerland

Location

Klinik Hirslanden

Zurich, CH-8008, Switzerland

Location

Stadtspital Waid

Zurich, CH-8037, Switzerland

Location

Unknown Facility

Zurich, CH-8044, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Related 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 treatment of patients with newly diagnosed, relapsed or chemotherapy resistant mantle cell lymphoma: SAKK 36/03. Hematol Oncol. 2009 Sep;27(3):154-9. doi: 10.1002/hon.891.

  PMID: 19274614 RESULT

MeSH Terms

Conditions

Lymphoma; Lymphoma, Mantle-Cell

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Felicitas Hitz, MD

  Cantonal Hospital of St. Gallen

  STUDY CHAIR

• Lucas Widmer, MD

  City Hospital Triemli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 6, 2005
• Study Start: June 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

CH (16)