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Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy

This study has been terminated.
(Lack of participations (8 of 25))
Sponsor:
ClinicalTrials.gov Identifier:
NCT00727207
First Posted: August 1, 2008
Last Update Posted: December 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Technische Universität München
  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 older patients with mantle cell lymphoma who received previous first-line or second-line chemotherapy.


Condition Intervention Phase
Lymphoma Drug: everolimus Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Phase II Trial on Efficacy of mTOR Inhibitor RAD001 as Maintenance Therapy for Patients Above 60 Years in Mantle Cell Lymphoma After First and Second Line Chemotherapy

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Progression-free survival

Secondary Outcome Measures:
  • Toxicity and feasibility
  • Efficacy
  • Comparison of duration of remission after first- vs second-line chemotherapy
  • Rate of objective remission

Estimated Enrollment: 35
Study Start Date: May 2008
Estimated Study Completion Date: September 2014
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the progression-free survival of older patients with mantle cell lymphoma receiving everolimus and who were previously treated with first- or second-line chemotherapy.

Secondary

  • Determine the toxicity and feasibility of treatment with this drug.
  • Determine the efficacy of this drug in these patients.
  • Compare the duration of remission after first- vs second-line chemotherapy.
  • Determine the rate of objective remission.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 3 years.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of mantle cell lymphoma
  • Stable disease after first- or second-line chemotherapy
  • No uncontrolled cerebral or leptomeningeal disease

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • Age ≥ 60 years or patients ≥ 40 and < 60 years who are not suitable for high-dose chemotherapy followed by autologous stem cell transplantation or allogeneic stem cell transplantation
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin > 9 g/dL
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • SGPT and SGOT ≤ 3 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • No other malignancies within the past 3 years except treated cervical carcinoma or basal cell cancer
  • No other serious or non-controlled illnesses (e.g., diabetes mellitus, uncontrolled hypertension, serious infections, serious malnutrition, unstable angina pectoris, weak heart, myocardial infarction within the past 6 months, chronic liver illness, active ulceration in the gastrointestinal tract, psychiatric illness)
  • No known HIV infection
  • No gastrointestinal disturbances that could influence the absorption of everolimus and cause short-intestine syndrome (e.g., atrophic gastritis)
  • No coagulation or bleeding diatheses
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Patients must have complied with their previous drug prescription

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • See Patient Characteristics
  • Recovered from all prior therapy
  • At least 2 weeks since prior surgery, radiotherapy, or systemic antitumor therapy
  • More than 4 weeks since prior experimental medication
  • No chronic therapy with systemic steroids or other immunosuppressants except rituximab
  • No prior organ transplantation
  • No therapy with vitamin K antagonist, except low-dose coumarin
  • No prior mTOR inhibitors
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727207


Locations
Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Ulrich Keller, MD Technische Universität München
  More Information

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT00727207     History of Changes
Other Study ID Numbers: CDR0000597004
KRDI-TUM-CRAD001C2428
EUDRACT: 2007-005116-12
EU-20855
First Submitted: July 31, 2008
First Posted: August 1, 2008
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by Technische Universität München:
recurrent mantle cell lymphoma
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage I 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
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents


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