Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00996983
First received: September 30, 2009
Last updated: November 27, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Pain
Neuropathic Pain
Intractable Pain
Cancer
Drug: ziconotide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • Response rate (> 30% reduction in VASPI) [ Time Frame: 48 hours after completion of titration phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16
Study Start Date: September 2009
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996983

Locations
Italy
Istituto Nazionale dei Tumori , Unita Terapia Antalgica
Napoli, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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
  More Information

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00996983     History of Changes
Other Study ID Numbers: ZIDON  EudraCT number: 2008-005307-26 
Study First Received: September 30, 2009
Last Updated: November 27, 2015
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Neuralgia
Pain, Intractable
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Ziconotide
omega-Conotoxins
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on December 09, 2016