Immunotherapy of the Paraneoplastic Syndromes

NCT00378326 | Completed Results DMC

• 1 other identifier: RDA-0572
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Paraneoplastic Syndromes

Keywords

paraneoplastic syndrome

Outcome Measures

Primary Outcomes (1)

• Survival of Patients With Paraneoplastic Disease Who Are Treated With Tacrolimus

  Survival in patients with paraneoplastic disease who are treated with Tacrolimus, from time of tacrolimus treatment

  through study completion, median 3 years of follow up

Secondary Outcomes (1)

• Cerebrospinal Fluid (CSF) Pleocytosis

  White blood cell count in CSF was measured at two time points, pre- and post-treatment

Study Arms (1)

Tacrolimus

EXPERIMENTAL

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

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

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

Also known as: FK506

Tacrolimus

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Paraneoplastic Disorder

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

Related Publications (1)

• Orange D, Frank M, Tian S, Dousmanis A, Marmur R, Buckley N, Parveen S, Graber JJ, Blachere N, Darnell RB. Cellular immune suppression in paraneoplastic neurologic syndromes targeting intracellular antigens. Arch Neurol. 2012 Sep;69(9):1132-40. doi: 10.1001/archneurol.2012.595.

  PMID: 22566506 DERIVED

MeSH Terms

Conditions

Paraneoplastic Syndromes

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Neoplasms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Robert B. Darnell, MD, PhD
• Organization: Rockefeller University

darnelr@rockefeller.edu

212-327-7474

Study Officials

• Robert Darnell, MD, PhD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2006
• First Posted: September 20, 2006
• Study Start: April 1, 2006
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 18, 2023
• Results First Posted: February 23, 2016

Record last verified: 2023-08

Locations

US (1)