N/A
N=26
Immunotherapy of the Paraneoplastic Syndromes
Paraneoplastic Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00378326 ↗Enrolled (actual)
26
Serious AEs
11.5%
Results posted
Feb 2016
Primary outcome: Primary: Survival of Patients With Paraneoplastic Disease Who Are Treated With Tacrolimus — 48 months
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tacrolimus (Drug)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- Rockefeller University
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival of Patients With Paraneoplastic Disease Who Are Treated With Tacrolimus |
48 | — |
| SECONDARY Cerebrospinal Fluid (CSF) Pleocytosis |
3; 3 | — |
Summary
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. 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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00378326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.