NP2 Enkephalin For Treatment of Intractable Cancer Pain

Neoplasms Clinical Trial

Official title:

A Phase II, Randomized, Double Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of NP2 in Subjects With Intractable Pain Due to Malignancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291901
• Other study ID #: NP2/P2/10/2
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2011
• Last updated: July 28, 2014
• Start date: January 2011
• Est. completion date: November 2013

Study information

• Verified date: July 2014
• Source: Diamyd Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease. A second purpose is to confirm safety and secondary efficacy measurements.

Description:

Chronic severe pain remains a significant unmet medical need in patients that have progressive cancer. Existing treatments have limited efficacy and also suffer significant side effects. This is a multi-center, randomized, double blind, placebo-controlled clinical trial designed to evaluate the impact of intradermal injection of NP2 in subjects who have intractable pain due to malignant disease. NP2 is a gene transfer vector engineered to express human preproenkephalin, a gene naturally involved in pain control. Delivery of NP2 directly to the site of pain caused by cancer is intended to provide increased Enkephalin peptides, which bind to opioid receptors, that may allow better pain control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

• Histologically confirmed malignant disease.

• Intractable pain related to malignancy.

• Females must be postmenopausal or practicing birth control.

• Able to provide appropriate written consent.

Main Exclusion Criteria:

• Positive pregnancy test prior to receiving study treatment.

• Serious uncontrolled medical condition other than malignancy (e.g. congestive heart failure, coagulopathy, uncontrolled diabetes).

• Evidence of active Hepatitis B, Hepatitis C, or HIV infection.

• Evidence of viral, bacterial, or fungal infection in the planned treatment area.

Related Conditions & MeSH terms

• Intractable Pain
• Neoplasms
• Pain, Intractable

Intervention

Biological:
• NP2
NP2 is a replication defective HSV-1 based gene transfer vector engineered to express human preproenkephalin. The drug will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.
• Placebo
The placebo (vehicle) will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.

Locations

Country	Name	City	State
United States	Christie Clinic	Champaign	Illinois
United States	Compassionate Cancer Care Medical Group, Inc.	Corona	California
United States	Hematology Oncology Associatesof Rhode Island	Cranston	Rhode Island
United States	Pain Research of Oregon	Eugene	Oregon
United States	Global Scientific Innovations	Evansville	Indiana
United States	Cancer Care Associates	Fresno	California
United States	TriWest Research Associates	La Mesa	California
United States	White Memorial Medical Center	Los Angeles	California
United States	Advanced Pharma CR	Miami	Florida
United States	Signal Point Clinical research Center	Middletown	Ohio
United States	Montana Cancer Institute Foundation	Missoula	Montana
United States	Better Health Clinical Research Inc	Newnan	Georgia
United States	Hematology Oncology Associates	Oakland	California
United States	HOPE Research Institute	Phoenix	Arizona
United States	Medical Therapy and Research	San Antonio	Texas
United States	Medical Oncology Associates	Spokane	Washington
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Diamyd Inc	invivodata, Inc., Paragon Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Measured by the Numerical Rating Scale (NRS)	• Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts.	Days -5 to -1 predosing and days 3 to 14 postdosing
Secondary	Opioid Pain Medication Usage Morphine Equivalent Units (MEU)	•Change from baseline of use of opioid pain medication average daily MEU of Placebo compared to Active NP2 cohorts	Days -5 to -1 predosing and 3 to 14 postdosing
Secondary	Quality of Life ECOG	•Quality of Life measured by Eastern Cooperative Oncology Group Performance Status (ECOG) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts.	Baseline and Week 1, 2 and 4
Secondary	Quality of Life SF-12	•Quality of Life measured by the 12-Item Short Form Health Survey (SF-12v2) at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts.	Baseline and Week 1, 2 and 4
Secondary	Pain SF-MPQ	•Short Form McGill Pain Questionnaire (SF-MPQ-2) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts	Baseline and Week 1, 2 and 4