Trial Information
Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate (> 30% reduction in VASPI)
Outcome Time Frame:
48 hours after completion of titration phase
Safety Issue:
No
Principal Investigator
Arturo Cuomo, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
NCI Naples, Division of Pain Therapy
Authority:
Italy: Ethics Committee
Study ID:
ZIDON
NCT ID:
NCT00996983
Start Date:
September 2009
Completion Date:
May 2013
Related Keywords:
- Pain
- Neuropathic Pain
- Intractable Pain
- Cancer
- Neuralgia
- Pain, Intractable