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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00727207
• Other study ID #: CDR0000597004
• Secondary ID: KRDI-TUM-CRAD001
• Status: Terminated
• Phase: Phase 2
• First received: July 31, 2008
• Last updated: December 13, 2012
• Start date: May 2008
• Est. completion date: September 2014

Study information

• Verified date: December 2012
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: September 2014
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Drug:
• everolimus

Locations

Country	Name	City	State
Germany	Klinikum Rechts Der Isar - Technische Universitaet Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival			No
Secondary	Toxicity and feasibility			Yes
Secondary	Efficacy			No
Secondary	Comparison of duration of remission after first- vs second-line chemotherapy			No
Secondary	Rate of objective remission			No