Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia

Not Recruiting

Trial ID: NCT00976248


The purpose of this research study is to determine the safety of RAD001(Everolimus) and the highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug that works by preventing cells in the body from growing and dividing. Information from basic and Phase I clinical research studies suggests that RAD001 also may help to prevent tumor growth in people with relapsed or refractory lymphoma.

Official Title

Phase II Study of Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia

Stanford Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology


Inclusion Criteria:

   - 18 years of age or older

   - Adequate liver and renal function as outlined in the protocol

   - Fasting serum cholesterol 300mg/dl or less OR 7.75mmol/L or less AND fasting
   triglycerides 2.5 x institutional ULN or less.

   - Clinicopathological diagnosis of Waldenstrom's macroglobulinemia as defined by
   consensus panel of the Second International Workshop on Waldenstrom's

   - No previous therapy for WM

   - Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a
   minimum IgM level of 2 times the upper limit of each institution's normal value or
   greater is required

   - ECOG Performance status of 0-2

   - Patients must have a life expectancy of at least 3 months

   - Baseline platelet and absolute neutrophil as outlined in the protocol

   - INR and PTT 1.5 x normalized ratio or less

   - A male subject agrees to use an acceptable method for contraception for the duration
   of study and for 8 weeks after the last dose of the study drug

   - Female subject either post-menopausal or surgically sterilized or willing to use
   acceptable methods of birth control for the duration of the study and for 8 weeks
   after the last dose of study drug

Exclusion Criteria:

   - Patients experiencing symptomatic hyperviscosity and requiring plasmapheresis. This
   includes any patient who, in the judgement of the investigator requires urgent
   response and will not be eligible. These patients have hyperviscosity which includes
   serum IgM levels of 5000 mg/dL or greater. Symptoms may include nosebleeds, visual
   complications, fatigue, headaches, confusion, etc.

   - Patients, who have had a major surgery or significant traumatic injury within 4 weeks
   of start of study drug, patients who have not recovered from the side effects of any
   major surgery or patients that may require major surgery during the course of the

   - Patients receiving chronic, systemic treatment with corticosteroids or another
   immunosuppressive agent. Topical or inhaled corticosteroids are allowed.

   - Patients should not receive any immunization with attenuated live vaccines within one
   week of study entry or during study period.

   - Patients who have had any severe and/or uncontrolled medical conditions or other
   conditions that would affect their participation in the study.

   - Impairment of gastrointestinal function or gastrointestinal disease that may
   significantly alter the absorption of RAD001.

   - Female patients that are pregnant or breast feeding, or adults of reproductive
   potential who are not using effective birth control methods.

   - Patients with known hypersensitivity to RAD001 or other rapamycins or to its

   - Patients with other malignancies within the past 3 years except for adequately treated
   carcinoma of the cervix or basal or squamous cell of the skin

   - Patients with known history of HIV seropositivity

   - History of noncompliance to medical regimens

   - Patients unwilling to or unable to comply with the protocol


drug: RAD001

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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