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:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00727207
First received: July 31, 2008
Last updated: December 13, 2012
Last verified: December 2012
  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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity and feasibility [ Designated as safety issue: Yes ]
  • Efficacy [ Designated as safety issue: No ]
  • Comparison of duration of remission after first- vs second-line chemotherapy [ Designated as safety issue: No ]
  • Rate of objective remission [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 31, 2008
Last Updated: December 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014