Immunotherapy of the Paraneoplastic Syndromes
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ClinicalTrials.gov Identifier: NCT00378326 |
Recruitment Status
:
Completed
First Posted
: September 20, 2006
Results First Posted
: February 23, 2016
Last Update Posted
: February 23, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Paraneoplastic Syndromes | Drug: Tacrolimus | Not Applicable |
Patients may stay either in-hospital while being treated with Tacrolimus, receive treatment as an outpatient, or a combination of the two. Additionally, patients who are too sick to be treated at Rockefeller University (RU) (eg. patients actively seizing), but are in need of urgent treatment, may be treated at either Memorial Sloan-Kettering Cancer Center or New York-Presbyterian Hospital. During treatment, patients will undergo blood draws, at set intervals (see section g below), clinical evaluation, possibly repeat leukapheresis or large volume blood draw, and lumbar puncture (see below). Since many patients live far away from New York, some of these procedures may be performed by RU staff or in conjunction with their local MDs.
Patients who are terminated from Tacrolimus treatment after 7-21 days will be followed up as outpatients for evaluation of their neurologic and medical status. Wherever possible, these patients will be seen on days 3 and 10 post treatment termination, and then on a biweekly basis for two months. Since many patients live far away from New York, they may instead be monitored in conjunction with their local MDs. Patients who show a definite clinical response to Tacrolimus may be maintained on a therapeutic dose for up to one year, and will be followed as outpatients. For patients receiving retreatment, they may be treated as inpatients or on an outpatient basis, at the discretion of the PI, on the same schedule as patients being treated initially. Long term improvement or decline in neurologic function will be objectively assessed by neurologic exam, which will be quantified by use of the Karnofsky scale (a measure of functional neurologic status). Since the vast majority of Hu patients decline over a 6-12 month period following diagnosis, a stable or improved Karnofsky score over such a time period will be taken as a measure of successful treatment. Repeat lumbar puncture (up to eight per year) and leukapheresis or large volume blood draw (approx. 100 cc) may be performed (up to four of each per year), especially in the setting of neurologic change, to assess the immune responses to the medications.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Immunotherapy of the Paraneoplastic Syndromes |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Tacrolimus
Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
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Drug: Tacrolimus
Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
Other Name: FK506
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- Survival of Patients With Paraneoplastic Disease Who Are Treated With Tacrolimus [ Time Frame: through study completion, median 3 years of follow up ]Survival in patients with paraneoplastic disease who are treated with Tacrolimus, from time of tacrolimus treatment
- Cerebrospinal Fluid (CSF) Pleocytosis [ Time Frame: White blood cell count in CSF was measured at two time points, pre- and post-treatment ]

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Ages Eligible for Study: | 14 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378326
United States, New York | |
Rockefeller University Hospital | |
New York, New York, United States, 10021 |
Principal Investigator: | Robert Darnell, MD, PhD | Rockefeller University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Rockefeller University |
ClinicalTrials.gov Identifier: | NCT00378326 History of Changes |
Other Study ID Numbers: |
RDA-0572 |
First Posted: | September 20, 2006 Key Record Dates |
Results First Posted: | February 23, 2016 |
Last Update Posted: | February 23, 2016 |
Last Verified: | January 2016 |
Keywords provided by Rockefeller University:
paraneoplastic syndrome |
Additional relevant MeSH terms:
Syndrome Paraneoplastic Syndromes Disease Pathologic Processes Neoplasms Tacrolimus |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Calcineurin Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |