Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer (ZIDON)
Primary Purpose
Pain, Neuropathic Pain, Intractable Pain
Status
Active
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
ziconotide
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility 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
Sites / Locations
- Istituto Nazionale dei Tumori , Unita Terapia Antalgica
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Response rate (> 30% reduction in VASPI)
Secondary Outcome Measures
toxicity
duration of analgesic response
Full Information
NCT ID
NCT00996983
First Posted
September 30, 2009
Last Updated
March 23, 2023
Sponsor
National Cancer Institute, Naples
1. Study Identification
Unique Protocol Identification Number
NCT00996983
Brief Title
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
Acronym
ZIDON
Official Title
Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neuropathic Pain, Intractable Pain, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ziconotide
Intervention Description
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
Primary Outcome Measure Information:
Title
Response rate (> 30% reduction in VASPI)
Time Frame
48 hours after completion of titration phase
Secondary Outcome Measure Information:
Title
toxicity
Time Frame
daily during drug titration, weekly thereafter
Title
duration of analgesic response
Time Frame
weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Cuomo, M.D.
Organizational Affiliation
NCI Naples, Division of Pain Therapy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gennaro Russo, M.D.
Organizational Affiliation
NCI Naples, Division of Pain Therapy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alessandro Morabito, M.D.
Organizational Affiliation
NCI Naples, Clinical Trials Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Nazionale dei Tumori , Unita Terapia Antalgica
City
Napoli
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
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