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

NCT00996983 | Unknown Phase 2

• 2 other identifiers: ZIDONEudraCT number: 2008-005307-26
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Neuropathic Pain; Intractable Pain; Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate (> 30% reduction in VASPI)

  48 hours after completion of titration phase

Secondary Outcomes (2)

• toxicity

  daily during drug titration, weekly thereafter

• duration of analgesic response

  weekly

Study Arms (1)

A

EXPERIMENTAL

Drug: ziconotide

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Istituto Nazionale dei Tumori , Unita Terapia Antalgica

Napoli, Italy

Location

MeSH Terms

Conditions

Pain; Neuralgia; Pain, Intractable; Neoplasms

Interventions

ziconotide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2009
• First Posted: October 16, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (1)