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Everolimus in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsored by: Swiss Group for Clinical Cancer Research
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00516412
  Purpose

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory mantle cell lymphoma.


Condition Intervention Phase
Lymphoma
Drug: everolimus
Procedure: molecular diagnostic method
Procedure: polymerase chain reaction
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Everolimus
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Everolimus (RAD001) for the Treatment of Patients With Relapsed or Therapy Resistant Mantle Cell Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse reactions [ Designated as safety issue: Yes ]
  • Time to progression [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Molecular response (PCR status after courses 3 and 6) in patients who test PCR-positive at baseline [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: August 2007
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Evaluation of the efficacy and tolerability of everolimus in patients with relapsed or therapy-resistant mantle cell lymphoma.

Secondary

  • Evaluation of the efficacy of everolimus to induce molecular remission in patients treated with this regimen.
  • Investigation of immunoglobulin heavy chain variable gene somatic hypermutations (Ig-V_H) in classical mantle cell lymphoma as compared to blastoid mantle cell lymphoma, in particular in regard to their frequency, mutation distribution pattern (antigen selected vs. at random), and the individually involved Ig-V_H families.
  • Evaluation of a putative impact of Ig-V_H on clinical outcome.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Bone marrow and peripheral blood samples are collected periodically and analyzed for molecular response by PCR. Molecular studies are also performed on DNA level formalin-fixed paraffin-embedded tissue samples.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Histologically or cytologically confirmed relapsed or chemotherapy/immunotherapy-resistant mantle cell lymphoma

    • No more than 3 lines of prior systemic treatment
  • At least one measurable lesion ≥ 15 mm in its greatest transverse diameter by CT scan

Exclusion criteria:

  • Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningeosis)
  • Newly diagnosed mantle cell lymphoma
  • Patients suitable for intensive treatment (e.g., hyperfractionated cyclophosphamide, vincristine, doxorubicin hydrochloride and dexamethasone with high-dose methotrexate and cytarabine [HyperCVAD])

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • WHO performance status ≤ 2
  • Creatinine clearance ≥ 30mL/min
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN
  • AST and ALT ≤ 2 times ULN
  • Neutrophils ≥ 1,500/mm³ (≥ 1,000/mm³ with marrow infiltration)
  • Thrombocytes ≥ 100,000/mm³ (≥ 75,000/mm³ in case of bone marrow infiltration)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after study participation

Exclusion criteria:

  • Prior or concurrent hematological malignancies

    • Patients with prior solid organ tumors that required no treatment over the last 5 years and are currently free of disease are eligible
  • Cardiovascular disease including any of the following:

    • NYHA class III or IV congestive heart failure
    • Unstable angina pectoris
    • Significant arrhythmia or arrhythmia requiring chronic treatment
    • Myocardial infarction in the last 3 months
  • Serious underlying medical condition which could impair the ability of the patient to participate in the trial including any of the following:

    • Uncontrolled diabetes mellitus
    • Gastric ulcers
    • Active autoimmune disease
    • Ongoing infection (e.g., HIV or hepatitis)

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

  • Prior radiation where the indicator lesion(s) are in the irradiated field
  • Prior organ transplantation
  • Participation in another clinical trial within 30 days prior to study entry
  • Concurrent anticancer drugs/treatments or experimental medications
  • Other concurrent investigational therapy
  • Other concurrent chemotherapy, immunotherapy, or radiotherapy (including palliative radiotherapy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516412

Locations
France
Centre Hospitalier Universitaire Bretonneau de Tours Recruiting
Tours, France, 37044
Contact: Contact Person     32-24-747-3712        
CHU de Grenoble - Hopital de la Tronche Recruiting
Grenoble, France, 38043
Contact: Contact Person     33-47-676-7575        
Hopital Haut Leveque Recruiting
Pessac, France, 33604
Contact: Contact Person     33-55-765-6511        
Institut Gustave Roussy Recruiting
Villejuif, France, F-94805
Contact: Contact Person     33-14-211-4321        
Italy
European Institute of Oncology Recruiting
Milan, Italy, 20141
Contact: Contact Person     39-02-5748-9538        
University of Bologna Medical School Recruiting
Bologna, Italy, 40138
Contact: Contact Person     39-51-636-3680        
Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland, CH-1011
Contact: Contact Person     41-21-314-0166        
City Hospital Triemli Recruiting
Zurich, Switzerland, CH-8063
Contact: Contact Person     41-44-466-1268        
Hirslanden Klinik Aarau Recruiting
Aarau, Switzerland, CH-5001
Contact: Contact Person     41-62-836-7833        
Hopitaux Universitaires de Geneve Recruiting
Thonex-Geneve, Switzerland, CH-1226
Contact: Contact Person     41-22-372-9862        
Universitaetsspital-Basel Recruiting
Basel, Switzerland, CH-4031
Contact: Contact Person     41-61-925-2710        
Kantonspital Aarau Recruiting
Aarau, Switzerland, CH-5001
Contact: Contact Person     41-62-838-6053        
Kantonsspital - St. Gallen Recruiting
St. Gallen, Switzerland, CH-9007
Contact: Contact Person     41-71-494-1066        
Kantonsspital Baden Recruiting
Baden, Switzerland, CH-5404
Contact: Contact Person     41-56-486-2511        
Kantonsspital Graubuenden Recruiting
Chur, Switzerland, CH-7000
Contact: Contact Person     41-81-256-7170        
Kantonsspital Olten Recruiting
Olten, Switzerland, CH-4600
Contact: Contact Person     41-62-311-4241        
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, CH-8400
Contact: Contact Person     41-52-266-3640        
Klinik Hirslanden Recruiting
Zurich, Switzerland, CH-8032
Contact: Contact Person     41-44-387-3780        
UniversitaetsSpital Zuerich Recruiting
Zurich, Switzerland, CH-8091
Contact: Contact Person     41-44-255-8902        
Inselspital Bern Recruiting
Bern, Switzerland, CH-3010
Contact: Contact Person     41-31-632-8430        
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Principal Investigator: Christoph Renner, MD UniversitaetsSpital Zuerich
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000560438, SWS-SAKK-36/06, EU-20749, EUDRACT-2007-001108-19
Study First Received: August 14, 2007
Last Updated: December 2, 2008
ClinicalTrials.gov Identifier: NCT00516412  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
recurrent mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Study placed in the following topic categories:
Everolimus
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Mantle cell lymphoma
Lymphoma
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 05, 2009