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Immunotherapy of the Paraneoplastic Syndromes

This study is currently recruiting participants.
Verified by Rockefeller University, April 2007

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   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:   Immunotherapy of the Paraneoplastic Syndromes

Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Assessment of immune responses
  • Clinical response in PND patients who are treated with Tacrolimus and Prednisone

Secondary Outcome Measures:
  • Collection and archiving of serum and lymphocytes for future studies on the mechanism of neuronal autoimmunity.

Study Start Date:   April 2006

Detailed Description:

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

Criteria

Inclusion Criteria:

  • Patients diagnosed with Paraneoplastic Disorder

Exclusion Criteria:

  • Metastasis (spread) of cancer to brain, History of additional active malignancy other than non-melanoma skin cancer, History of Hepatitis B, Hepatitis C, HIV or Syphilis.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378326

Contacts
Contact: Noreen Buckley, APN     212-327-7454     nbuckley@rockefeller.edu    

Locations
United States, New York
Rockefeller University Hospital     Recruiting
      New York, New York, United States, 10021
      Principal Investigator: Robert Darnell, MD, PhD            

Sponsors and Collaborators
Rockefeller University

Investigators
Principal Investigator:     Robert Darnell, MD, PhD     Rockefeller University    
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by Rockefeller University:
paraneoplastic syndrome  

Study placed in the following topic categories:
Paraneoplastic Syndromes
Tacrolimus

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on September 05, 2008




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