Clinical trial NCT00234026: Gemcitabine in Treating Patients With Newly Diagnosed, Relapsed, or Chemotherapy-Resistant Mantle Cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Swiss Group for Clinical Cancer Research
Sponsor class: OTHER
First posted: 2005-10-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Objective response at end of study treatment
Secondary outcomes:
measure: Adverse reactions at end of study treatment
measure: Time to progression
measure: Response duration
measure: Time to treatment failure at end of study treatment
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonspital Aarau
city: Baden
country: Switzerland
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland
city: Bulach
country: Switzerland
facility: Spital Buelach
city: Schlieren
country: Switzerland
facility: Spital Limmattal
city: St. Gallen
country: Switzerland
facility: Kantonsspital - St. Gallen
city: Uster
country: Switzerland
facility: Spital Uster
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
city: Zurich
country: Switzerland
facility: Onkozentrum - Klinik im Park
city: Zurich
country: Switzerland
facility: City Hospital Triemli
city: Zurich
country: Switzerland
facility: Klinik Hirslanden
city: Zurich
country: Switzerland
facility: Stadtspital Waid
city: Zurich
country: Switzerland
city: Zurich
country: Switzerland
facility: UniversitaetsSpital Zuerich
Study officials:
affiliation: Cantonal Hospital of St. Gallen
name: Felicitas Hitz, MD
role: STUDY_CHAIR
affiliation: City Hospital Triemli
name: Lucas Widmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.