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.

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