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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


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
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