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

March 23, 2023 updated by: National Cancer Institute, Naples

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy
        • Istituto Nazionale dei Tumori , Unita Terapia Antalgica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate (> 30% reduction in VASPI)
Time Frame: 48 hours after completion of titration phase
48 hours after completion of titration phase

Secondary Outcome Measures

Outcome Measure
Time Frame
toxicity
Time Frame: daily during drug titration, weekly thereafter
daily during drug titration, weekly thereafter
duration of analgesic response
Time Frame: weekly
weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZIDON
  • EudraCT number: 2008-005307-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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