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

NCT00727207 | Terminated Phase 2

• 4 other identifiers: CDR0000597004KRDI-TUM-CRAD001C2428EUDRACT: 2007-005116-12EU-20855
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (4)

• Toxicity and feasibility

• Efficacy

• Comparison of duration of remission after first- vs second-line chemotherapy

• Rate of objective remission

Interventions

everolimus DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Mantle-Cell

Interventions

Everolimus

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)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Ulrich Keller, MD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 1, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: September 1, 2014
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

DE (1)