Intratecal Ziconotide in the treatment of neuropatic pain in cancer patients.A phase II study. - ZIDO

Phase 1

Conditions: europatic pain in cancer patients.
MedDRA version: 9.1Level: SOCClassification code 10029104

Registration Number: EUCTR2008-005307-26-IT

Lead Sponsor: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 16

Inclusion Criteria

1.Diagnosis of malignant tumors; 2. Severe neuropatic pain (VASPI 6 or greater); 3.Pain not responsive to opioids and adjuvant drugs; 4. Age 18 or greater; 5.Performance Status 0-2; Life expectancy greater than 1 month; effective contraception in female patients if the risk of conception exists; 8. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Exposure to experimental drugs in the previous 30 days; 2.Nursing and/or pregnant women; 3. Contraindication of intratecal analgesia (including active infections or disorders in liquor circulation); 4.Brain metastases; 5.INR greater than 2; 6.Contraindication of ziconotide use; 7.Incapacity or refusal to sign the informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the activity of intratecal ziconotide in terms of control of severe neuropatic pain not responsive to opioids and adjuvant drugs in cancer patients;Secondary Objective: To evaluate the tolerability of intratecal ziconotide in terms of short and long term adverse events. To describe duration of analgesic effect of ziconotide.;Primary end point(s): Analgesic response to ziconotide, defined as an absolute reduction of 30% or greater in median VASPI scale 48 hours after the last dose increasing as compared to initial value (end of tritation), without modifing current systemic analgesic therapy.

Secondary Outcome Measures