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

National Cancer Institute, Naples

Status and phase

Active, not recruiting

Phase 2

Conditions

Intractable Pain

Neuropathic Pain

Cancer

Pain

Treatments

Drug: ziconotide

Study type

Interventional

Funder types

Other

Identifiers

NCT00996983

ZIDON

EudraCT number: 2008-005307-26

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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