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NP2 Enkephalin For Treatment of Intractable Cancer Pain

Primary Purpose

Intractable Pain, Neoplasms

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

NP2

Placebo

About this trial

This is an interventional treatment trial for Intractable Pain focused on measuring pain, cancer, malignancy, intractable, gene therapy, enkephalin, opioid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active NP2

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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.

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

Full Information

NCT ID

NCT01291901

First Posted

February 4, 2011

Last Updated

July 28, 2014

Sponsor

Diamyd Inc

Collaborators

Paragon Biomedical, invivodata, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01291901

Brief Title

NP2 Enkephalin For Treatment of Intractable Cancer Pain

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 Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Diamyd Inc

Collaborators

Paragon Biomedical, invivodata, Inc.

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intractable Pain, Neoplasms

Keywords

pain, cancer, malignancy, intractable, gene therapy, enkephalin, opioid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active NP2

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

NP2

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain Measured by the Numerical Rating Scale (NRS)

Description

• Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts.

Time Frame

Days -5 to -1 predosing and days 3 to 14 postdosing

Secondary Outcome Measure Information:

Title

Opioid Pain Medication Usage Morphine Equivalent Units (MEU)

Description

•Change from baseline of use of opioid pain medication average daily MEU of Placebo compared to Active NP2 cohorts

Time Frame

Days -5 to -1 predosing and 3 to 14 postdosing

Title

Quality of Life ECOG

Description

•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.

Time Frame

Baseline and Week 1, 2 and 4

Title

Quality of Life SF-12

Description

•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.

Time Frame

Baseline and Week 1, 2 and 4

Title

Pain SF-MPQ

Description

•Short Form McGill Pain Questionnaire (SF-MPQ-2) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts

Time Frame

Baseline and Week 1, 2 and 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Darren Wolfe, Ph.D.

Organizational Affiliation

Diamyd Inc

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

David Fink, M.D.

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

HOPE Research Institute

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85050

Country

United States

Facility Name

Arizona Clinical Research Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85715

Country

United States

Facility Name

Compassionate Cancer Care Medical Group, Inc.

City

Corona

State/Province

California

ZIP/Postal Code

92879

Country

United States

Facility Name

Cancer Care Associates

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

TriWest Research Associates

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

White Memorial Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Hematology Oncology Associates

City

Oakland

State/Province

California

ZIP/Postal Code

94609

Country

United States

Facility Name

Advanced Pharma CR

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Better Health Clinical Research Inc

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30265

Country

United States

Facility Name

Christie Clinic

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61820

Country

United States

Facility Name

Global Scientific Innovations

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Montana Cancer Institute Foundation

City

Missoula

State/Province

Montana

ZIP/Postal Code

59802

Country

United States

Facility Name

Center for Clinical Research

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Signal Point Clinical research Center

City

Middletown

State/Province

Ohio

ZIP/Postal Code

45042

Country

United States

Facility Name

Pain Research of Oregon

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Hematology Oncology Associatesof Rhode Island

City

Cranston

State/Province

Rhode Island

ZIP/Postal Code

02920

Country

United States

Facility Name

Medical Therapy and Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

Medical Oncology Associates

City

Spokane

State/Province

Washington

ZIP/Postal Code

99208

Country

United States

12. IPD Sharing Statement

Learn more about this trial

NP2 Enkephalin For Treatment of Intractable Cancer Pain

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NP2 Enkephalin For Treatment of Intractable Cancer Pain

Intractable Pain, Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial