NCT01212367

Brief Summary

This research will study how to activate the immune system by using gene transfer. Gene transfer involves inserting a specially designed gene into cancer cells. A gene is a part of the genetic code that instructs the cells of our bodies to produce specific compounds (proteins) important for the makeup or function of the cell. The study hypothesis is that repeated doses of SCH 721015 given over a three day interval would result in gene transfer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

6.2 years

First QC Date

September 29, 2010

Last Update Submit

September 21, 2015

Conditions

Malignant Pleural Mesothelioma

Keywords

Gene transferImmunologyCancer

Outcome Measures

Primary Outcomes (1)

  • To analyze gene transfer with two does separated by three-day interval

    After the first dose and at each visit until day 94

Study Arms (2)

Dose Level 1

EXPERIMENTAL
Biological: SCH 721015

Dose Level 2

EXPERIMENTAL

This is a dose de escalation.

Biological: SCH 721015

Interventions

SCH 721015BIOLOGICAL

1.0 x 10e12 viral particles on Days 1 and 4

Also known as: Adenoviral-mediated Interferon-alpha, Ad.IFN-alpha
Dose Level 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • evidence of progressive disease after standard first line treatment of mesothelioma; OR patient has refused standard first line treatment of mesothelioma
  • evaluable disease
  • No radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic agents within 14 days prior to infusion of the IFN-α vector
  • Must have a pleural space involved with tumor accessible for pleural catheter insertion
  • FEV1\> 1 liter or 40% of predicted value
  • Must have an anti-adenoviral neutralizing antibody titer equal to or less than 1:1000. This will be measured by the Penn Vector Core

You may not qualify if:

  • Presence of HIV or Hepatitis B infection
  • Use of concurrent systemic steroids, immunosuppressives, or any other medications that can directly or indirectly suppress the immune system
  • Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependence, significant chronic obstructive pulmonary disease (COPD), end stage liver or renal disease
  • Presence of untreated brain metastases
  • Prior bone marrow or stem cell transplants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Sterman DH, Haas A, Moon E, Recio A, Schwed D, Vachani A, Katz SI, Gillespie CT, Cheng G, Sun J, Papasavvas E, Montaner LJ, Heitjan DF, Litzky L, Friedberg J, Culligan M, June CH, Carroll RG, Albelda SM. A trial of intrapleural adenoviral-mediated Interferon-alpha2b gene transfer for malignant pleural mesothelioma. Am J Respir Crit Care Med. 2011 Dec 15;184(12):1395-9. doi: 10.1164/rccm.201103-0554CR. Epub 2011 Jun 3.

    PMID: 21642245DERIVED

MeSH Terms

Conditions

Mesothelioma, MalignantNeoplasms

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Daniel Sterman

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2010

First Posted

September 30, 2010

Study Start

February 1, 2009

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

US(1)