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

• Sponsor: National Cancer Institute, Naples (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00996983
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Duration (Months): 159
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pain; Neuropathic Pain; Intractable Pain; Cancer	Drug: ziconotide	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer
• Study Start Date: Sep 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Response rate (> 30% reduction in VASPI) [48 hours after completion of titration phase]

Secondary Outcome Measures

1. toxicity [daily during drug titration, weekly thereafter]

2. duration of analgesic response [weekly]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute, Naples
• ClinicalTrials.gov Identifier: NCT00996983
• Other Study ID Numbers: ZIDON; EudraCT number: 2008-005307-26
• First Posted: Oct 16, 2009
• Last Update Posted: Mar 5, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Neuralgia; Pain, Intractable; Ziconotide

Study Results

No Results Posted as of Mar 5, 2021