Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer (ZIDON)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Cancer Institute, Naples
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00996983
First received: September 30, 2009
Last updated: January 3, 2014
Last verified: January 2014

September 30, 2009
January 3, 2014
September 2009
April 2014   (final data collection date for primary outcome measure)
Response rate (> 30% reduction in VASPI) [ Time Frame: 48 hours after completion of titration phase ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00996983 on ClinicalTrials.gov Archive Site
  • toxicity [ Time Frame: daily during drug titration, weekly thereafter ] [ Designated as safety issue: Yes ]
  • duration of analgesic response [ Time Frame: weekly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer

Neuropathic pain is difficult to control because it is only partially sensitive to opioid analgesics, and requires the addition of other therapies such as antidepressants and epileptics. Ziconotide is a drug that is used to treat neuropathic pain in patients who have had inadequate pain control with prior combination of medicines.

The purpose of this study is to evaluate the effects and the tolerability of intrathecal ziconotide in cancer patients suffering from severe neuropathic pain not controlled by previous therapies.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pain
  • Neuropathic Pain
  • Intractable Pain
  • Cancer
Drug: ziconotide
intrathecal ziconotide starting at 2.4 micrograms/day, with titration daily to achieve adequate pain control up to maximum dose of 21.6 micrograms/day
Experimental: A
Intervention: Drug: ziconotide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
September 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of neoplasm
  • Neuropathic pain level VASPI > or = 6 (0-10 scale)
  • Inadequate pain relief with opioid analgesics and adjuvants
  • Age > or = 18 years
  • Performance status ECOG 0-2
  • Life expectancy at least one month
  • Adequate contraception in women of child-bearing potential
  • Signed Informed Consent

Exclusion Criteria:

  • Use of experimental drugs within previous 30 days
  • Pregnancy or lactation
  • Contraindication to the use of intrathecal analgesics, including active infection or conditions that could alter the circulation of cerebrospinal fluid
  • Presence of cerebral metastasis
  • INR > 2
  • Contraindication to the use of ziconotide
  • Unable or unwilling to provide informed consent
Both
18 Years and older
No
Contact: Francesco Perrone, M.D., Ph.D. +390815903571 francesco.perrone@usc-intnapoli.net
Contact: Massimo Di Maio, M.D. +390815903631 massimo.dimaio@usc-intnapoli.lnet
Italy
 
NCT00996983
ZIDON, EudraCT number: 2008-005307-26
No
National Cancer Institute, Naples
National Cancer Institute, Naples
Not Provided
Principal Investigator: Arturo Cuomo, M.D. NCI Naples, Division of Pain Therapy
Principal Investigator: Gennaro Russo, M.D. NCI Naples, Division of Pain Therapy
Principal Investigator: Alessandro Morabito, M.D. NCI Naples, Clinical Trials Unit
National Cancer Institute, Naples
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP