Treatment of Advanced Head and Neck Cancer

This study has been terminated.
(Deemed ineffective)
Sponsor:
Information provided by (Responsible Party):
David Goldenberg, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00982696
First received: September 22, 2009
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Carcinoma, Squamous Cell of Head and Neck
Biological: Opioid Growth Factor
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Advanced Head and Neck Cancer With Opioid Growth Factors: Phase II

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Progression of tumor measured with CT scan [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Metastatic development using CT scan [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Pharmacokinetics of OGF [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: February 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Opioid Growth Factor (OGF)
Biological: Opioid Growth Factor
250ug per kilogram weekly IV infusions
Other Names:
  • endogenous opioid peptide
  • Met-enkephalin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982696

Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: David Goldenberg, MD Penn State College of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: David Goldenberg, Associate Professor of Medicine and Surgery, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00982696     History of Changes
Obsolete Identifiers: NCT00905099
Other Study ID Numbers: PSU 23429
Study First Received: September 22, 2009
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Milton S. Hershey Medical Center:
head and neck cancer
opioid growth factor

Additional relevant MeSH terms:
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Neoplasms by Site
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014