Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Waldenstrom's Macroglobulinemia
NCT ID: NCT01125293 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-280

 

The purpose of this research study is to test the safety of the combination of everolimus, rituximab and bortezomib. Everolimus is a drug that works by preventing cells in your body from growing and dividing. Information from basic and other clinical research suggests that everolimus may also inhibit tumor growth in people with relapsed or refractory lymphoma. The FDA has approved everolimus for the treatment of multiple myeloma, a cancer that is closely related to Waldenstrom's Macroglobulinemia. Rituximab is approved by the FDA for the treatment of non-Hodgkin's lymphoma, which included Waldenstrom's Macroglobulinemia. Funding Source - FDA OOPD

 

Conducting Institutions:
Dana-Farber Cancer Institute

Overall PI:
Irene Ghobrial, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Meghan Rourke, 617-632-5933, meghan_rourke@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - 18 years of age or older - Patients must have received prior therapies for their WM and have relapsed or refractory WM requiring therapy. Any number of prior therapies is acceptable. Patients must not have been refractory to rituximab. The last rituximab must be at least 3 months prior to the start of treatment. Prior treatment with bortezomib and/or everolimus is permitted. - Measurable monoclonal IgM protein in the serum and lymphoplasmacytic cells in the bone marrow during any previous bone marrow biopsy. - CD30 positive disease based on any previous bone marrow immuno-histochemistry or flow cytometric analysis performed prior to enrollment. - ECOG Performance Status 0, 1 or 2 - Laboratory values as outlined in the protocol - Capable of swallowing intact study medication tablets - Life expectancy of 12 weeks or greater Exclusion Criteria: - Uncontrolled infection - Other active malignancies - Cytotoxic chemotherapy 3 weeks or less, or biologic or targeted novel therapy 2 weeks or less, or corticosteroids 2 weeks or less, or radiation therapy 2 weeks or less, or any ancillary treatment considered investigation 2 weeks or less, prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than WM. - Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception throughout the trial and for 8 weeks after the last dose of study treatment. - Known to be HIV positive, or Hepatitis B positive - Patient has Grade 2 or higher peripheral neuropathy within 14 days of enrollment - Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection fo basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy. - Severely impaired lung function - Uncontrolled diabetes - Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis - Impairment of gastrointestinal function or gastrointestinal disease - Patients with active, bleeding diathesis - Myocardial infarction within 6 months prior to enrollment or had NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. - Hypersensitivity to everolimus or other rapamycins or to is excipients - Patients who may need or are receiving live vaccines for immunization - Serious medical or psychiatric illness likely to interfere with participation in this clinical study
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