Safety and Activity Study of Intrathecally Administered Z... | NCT00996983

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

NCT00996983

Sponsor

National Cancer Institute, Naples

Status

Unknown status

Last Update Posted

Mar 24, 2023Actual

Enrollment

16Estimated

Phase

Phase 2

Conditions

Pain
Neuropathic Pain
Intractable Pain
Cancer

Interventions

ziconotide

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT number: 2008-005307-26

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Sep 30, 2009

First Submission Date that Met QC Criteria

Oct 15, 2009

First Posted Date

Oct 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2023

Last Update Posted Date

Mar 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: ziconotide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ziconotide	Drug	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	A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Nazionale dei Tumori , Unita Terapia Antalgica		Naples			Italy

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D009437	Neuralgia
D010148	Pain, Intractable
D009369	Neoplasms

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010523	Peripheral Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C078452	ziconotide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided