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| Sponsored by: |
Rockefeller University |
| Information provided by: | Rockefeller University |
| ClinicalTrials.gov Identifier: | NCT00378326 |
Purpose
We treat a subset of patients with paraneoplastic neurologic disorders, including those with Yo-mediated paraneoplastic cerebellar degeneration (PCD), the Hu syndrome, which is most commonly associated with small cell lung cancer (SCLC) - paraneoplastic subacute sensory neuropathy, encephalomyelitis, limbic encephalopathy, autonomic neuropathy - and the Ri Syndrome (a.k.a. POMA - Paraneoplastic Opsoclonus-Myoclonus Ataxia), as well as those patients suspected to have a paraneoplastic neurologic disorder but in whom a characteristic antibody has not yet been identified. Our treatment protocol consists of immune suppression therapy using tacrolimus (FK506), a potent inhibitor of lymphocyte proliferation that is commonly used to prevent organ transplant rejection.
| Condition | Intervention |
|
Paraneoplastic Syndromes |
Drug: Treatment of paraneoplastic syndrome with immune suppression using tacrolimus (FK506) |
| ChemIDplus related topics: | Tacrolimus Tacrolimus anhydrous |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Immunotherapy of the Paraneoplastic Syndromes |
| Study Start Date: | April 2006 |
Patients typically spend two to three weeks as in-patients at the Rockefeller University Hospital. Patients will have a complete history as well as complete general and neurologic examinations, and will be assessed for baseline neurologic, hepatic, hematopoietic, cardiovascular, pulmonary, and renal function (including 24 hour creatinine clearance). Eligible patients will then have a lumbar puncture (spinal tap) and a leukapheresis, a procedure like blood donation during which white blood cells are removed but red blood cells are returned. Tacrolimus will be given in two divided oral doses, in conjunction with oral prednisone. Patients will be treated for up to three weeks, at which time they will be discontinued from treatment with tacrolimus and prednisone unless they have shown definite signs of a beneficial clinical response. Patients will have electrolyte, metabolic, and hematologic measurements, peak and trough serum tacrolimus levels, renal function, and neurologic status serially monitored, requiring approximately one tablespoon of blood per assay. Patients who cannot tolerate tacrolimus without renal dysfunction will be terminated from protocol. Repeat leukapheresis and/or large volume blood draw, and lumbar puncture may be performed either during or after the in-patient stay, with the patient's consent. Patients will be followed after leaving the hospital to monitor for clinical changes and for drug side-effects.
Eligibility
| Ages Eligible for Study: | 16 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Noreen Buckley, APN | 212-327-7454 | nbuckley@rockefeller.edu |
| United States, New York | |||||
| Rockefeller University Hospital | Recruiting | ||||
| New York, New York, United States, 10021 | |||||
| Principal Investigator: Robert Darnell, MD, PhD | |||||
| Rockefeller University |
| Principal Investigator: | Robert Darnell, MD, PhD | Rockefeller University |
More Information
Related Info 
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| Study ID Numbers: | RDA-0572-0406 |
| First Received: | September 18, 2006 |
| Last Updated: | October 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00378326 |
| Health Authority: | United States: Institutional Review Board |
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