Clinical trial NCT00727207: Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2008-08-01
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Progression-free survival
Secondary outcomes:
measure: Toxicity and feasibility
measure: Efficacy
measure: Comparison of duration of remission after first- vs second-line chemotherapy
measure: Rate of objective remission
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Study officials:
affiliation: Technical University of Munich
name: Ulrich Keller, MD
role: PRINCIPAL_INVESTIGATOR
References: