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Treatment of Advanced Head and Neck Cancer

Primary Purpose

Carcinoma, Squamous Cell of Head and Neck

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Opioid Growth Factor
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell of Head and Neck focused on measuring head and neck cancer, opioid growth factor

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically and cytologically confirmed diagnosis of squamous cell carcinoma.
  • Patients not amenable to curative treatments with further surgery and/or radiation.
  • Patient has failed treatment with chemotherapy
  • Lesions must be distinct and the minimum measurements must be at least 2.0 cm x 2.0 cm at baseline.
  • Karnofsky performance rating of at lest 50%.

Exclusion Criteria:

  • Patients with severe and unstable cardiovascular disease.
  • Treatment naive subjects will not be included for study.
  • Patients with poorly controlled diabetes, seizure disorder, primary CNS tumors or known brain metastases will be excluded.
  • Pregnant or nursing women.
  • Patients requiring antibiotics in the preceding 2 weeks for a serious infection are not eligible.
  • Patients with a fever > 37.8 degrees C.
  • Pulse < 60 or > 110
  • Systolic blood pressure > 170 or less than 90 are not eligible.
  • Patients with nasopharyngeal squamous cell carcinoma will be excluded
  • Patients with hypercalcemia will be excluded from this study

Sites / Locations

  • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Opioid Growth Factor (OGF)

Outcomes

Primary Outcome Measures

Progression of tumor measured with CT scan

Secondary Outcome Measures

Metastatic development using CT scan

Full Information

First Posted
September 22, 2009
Last Updated
September 18, 2014
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00982696
Brief Title
Treatment of Advanced Head and Neck Cancer
Official Title
Treatment of Advanced Head and Neck Cancer With Opioid Growth Factors: Phase II
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
Deemed ineffective
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will investigate the efficacy of opioid growth factor (OGF) on tumor size and survival in patients with head and neck cancer who have failed standard therapy.
Detailed Description
The major focus of the study will involve assessment of tumor response, patient survival, tolerance to drug, quality of life, depression, pain management and nutrition. During the study we will begin to study the kinetics of opioid growth factor (OGF) exogenous administration and the relationship between plasma OGF levels, stage of disease and length of treatment. Apart from potentially having growth inhibitory action on cancer, OGF may have some psychological and other biological effects which may prove to be beneficial in the patient's treatment. Presently there is no effective therapy or quality of life adjuvants for the 30,000 Americans who develop head and neck cancer yearly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell of Head and Neck
Keywords
head and neck cancer, opioid growth factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Opioid Growth Factor (OGF)
Intervention Type
Biological
Intervention Name(s)
Opioid Growth Factor
Other Intervention Name(s)
endogenous opioid peptide, Met-enkephalin
Intervention Description
250ug per kilogram weekly IV infusions
Primary Outcome Measure Information:
Title
Progression of tumor measured with CT scan
Time Frame
every 3 months
Secondary Outcome Measure Information:
Title
Metastatic development using CT scan
Time Frame
every 3 months
Other Pre-specified Outcome Measures:
Title
Pharmacokinetics of OGF
Time Frame
every 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically and cytologically confirmed diagnosis of squamous cell carcinoma. Patients not amenable to curative treatments with further surgery and/or radiation. Patient has failed treatment with chemotherapy Lesions must be distinct and the minimum measurements must be at least 2.0 cm x 2.0 cm at baseline. Karnofsky performance rating of at lest 50%. Exclusion Criteria: Patients with severe and unstable cardiovascular disease. Treatment naive subjects will not be included for study. Patients with poorly controlled diabetes, seizure disorder, primary CNS tumors or known brain metastases will be excluded. Pregnant or nursing women. Patients requiring antibiotics in the preceding 2 weeks for a serious infection are not eligible. Patients with a fever > 37.8 degrees C. Pulse < 60 or > 110 Systolic blood pressure > 170 or less than 90 are not eligible. Patients with nasopharyngeal squamous cell carcinoma will be excluded Patients with hypercalcemia will be excluded from this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Goldenberg, MD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2758319
Citation
Zagon IS, McLaughlin PJ. Endogenous opioid systems regulate growth of neural tumor cells in culture. Brain Res. 1989 Jun 19;490(1):14-25. doi: 10.1016/0006-8993(89)90425-3. Erratum In: Brain Res 1989 Oct 2;498(2):405.
Results Reference
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PubMed Identifier
3496822
Citation
Wybran J, Schandene L, Van Vooren JP, Vandermoten G, Latinne D, Sonnet J, De Bruyere M, Taelman H, Plotnikoff NP. Immunologic properties of methionine-enkephalin, and therapeutic implications in AIDS, ARC, and cancer. Ann N Y Acad Sci. 1987;496:108-14. doi: 10.1111/j.1749-6632.1987.tb35753.x. No abstract available.
Results Reference
background
PubMed Identifier
6640516
Citation
Zagon IS, McLaughlin PJ. Opioid antagonists inhibit the growth of metastatic murine neuroblastoma. Cancer Lett. 1983 Nov;21(1):89-94. doi: 10.1016/0304-3835(83)90087-3.
Results Reference
background
PubMed Identifier
19014324
Citation
Goldenberg D, Zagon IS, Fedok F, Crist HS, McLaughlin PJ. Expression of opioid growth factor (OGF)-OGF receptor (OGFr) axis in human nonmedullary thyroid cancer. Thyroid. 2008 Nov;18(11):1165-70. doi: 10.1089/thy.2008.0112.
Results Reference
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Links:
URL
http://www.pennstatehershey.org/web/cancer/research
Description
Penn State Hershey Cancer Institute

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Treatment of Advanced Head and Neck Cancer

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