NP2 Enkephalin For Treatment of Intractable Cancer Pain

Sponsor

Diamyd Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01291901

Collaborator

Paragon Biomedical (Industry), invivodata, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

1.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intractable Pain Neoplasms	Biological: NP2 Biological: Placebo	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active NP2 Single intradermal dose of active NP2. An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.	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 Comparator: Placebo Single intradermal dose of placebo (vehicle). An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.	Biological: 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.

Arm

Intervention/Treatment

Experimental: Active NP2

Single intradermal dose of active NP2. An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.

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 Comparator: Placebo

Single intradermal dose of placebo (vehicle). An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.

Biological: 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.

Outcome Measures

Primary Outcome Measures

Pain Measured by the Numerical Rating Scale (NRS) [Days -5 to -1 predosing and days 3 to 14 postdosing]
• Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts.

Secondary Outcome Measures

Opioid Pain Medication Usage Morphine Equivalent Units (MEU) [Days -5 to -1 predosing and 3 to 14 postdosing]
•Change from baseline of use of opioid pain medication average daily MEU of Placebo compared to Active NP2 cohorts
Quality of Life ECOG [Baseline and Week 1, 2 and 4]
•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.
Quality of Life SF-12 [Baseline and Week 1, 2 and 4]
•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.
Pain SF-MPQ [Baseline and Week 1, 2 and 4]
•Short Form McGill Pain Questionnaire (SF-MPQ-2) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HOPE Research Institute	Phoenix	Arizona	United States	85050
2	Arizona Clinical Research Center	Tucson	Arizona	United States	85715
3	Compassionate Cancer Care Medical Group, Inc.	Corona	California	United States	92879
4	Cancer Care Associates	Fresno	California	United States	93720
5	TriWest Research Associates	La Mesa	California	United States	91942
6	White Memorial Medical Center	Los Angeles	California	United States	90033
7	Hematology Oncology Associates	Oakland	California	United States	94609
8	Advanced Pharma CR	Miami	Florida	United States	33175
9	Better Health Clinical Research Inc	Newnan	Georgia	United States	30265
10	Christie Clinic	Champaign	Illinois	United States	61820
11	Global Scientific Innovations	Evansville	Indiana	United States	47714
12	Montana Cancer Institute Foundation	Missoula	Montana	United States	59802
13	Center for Clinical Research	Winston-Salem	North Carolina	United States	27103
14	Signal Point Clinical research Center	Middletown	Ohio	United States	45042
15	Pain Research of Oregon	Eugene	Oregon	United States	97401
16	Hematology Oncology Associatesof Rhode Island	Cranston	Rhode Island	United States	02920
17	Medical Therapy and Research	San Antonio	Texas	United States	78217
18	Medical Oncology Associates	Spokane	Washington	United States	99208