Clinical Trial NCI UC12H05
- Phase I/II Investigation of Temsirolimus Plus Lenalidomide in Relapsed Non-Hodgkin Lymphomas
- Principal Investigator
- Adam M Petrich
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.NCI UC12H05
- The purpose of this study is threefold; first (phase I portion) to determine the safe dose of lenalidomide to be used with temsirolimus for the treatment of relapsed lymphomas (disease has come back or did not respond to treatment); second (phase II portion) to determine disease response (good and/or bad) to the study drugs; and third to determine the toxicity and safety of the treatment.
- Treatment for lymphoma can include chemotherapy or radiation. In some cases the disease comes back (recurs) or does not respond (is refractory) to treatment. Relapsed lymphomas are hard to treat with current drugs. Temsirolimus and lenalidomide are approved for use in other cancers but are experimental in their use for treating lymphomas. Both have antitumor effects. Temsirolimus interferes with a protein (mTOR) in the cell that transmits a signal to stimulate cell growth and survival. Temsirolimus may inhibit (stop the function of) the mTOR protein. Lenalidomide is an anti-angiogenesis medicine. Anti-angiogenesis medicines fight cancer by cutting off a tumor’s blood supply, stopping the blood and nutrients it needs to grow. Both drugs may cause the cancer cells to stop growing or die.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must have Hodgkin or non-Hodgkin lymphoma that has been previously treated.
- Description of Treatment
- Participants will receive temsirolimus weekly intravenously (in the vein) through a small needle. This will take about 30 minutes. In addition, participants will receive lenalidomide, which is a capsule taken by mouth. Participants will continue on the study for up to 52 weeks as long as the treatment is effective (shrinks the lymphoma) or until the doctor decides it is in the participant’s best interest to be taken off the study drugs.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
- An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumor and Lymphoma Malignancies
- A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma
- Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma
- A Phase I-II Trial of Brentuximab Vedotin Plus Rituximab as Frontline Therapy for Patients with CD30+ and/or EBV+ Lymphomas
- A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
last updated: 22-Oct-14 10:21 AM
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