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

September 22, 2009
March 28, 2014
February 2008
November 2011   (final data collection date for primary outcome measure)
Progression of tumor measured with CT scan [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
Evaluate the growth inhibitory effects of OGF by treating patients with advanced head and neck cancer who have failed prior therapy (surgery, radiation, or chemotherapy) in a prospective study. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00982696 on ClinicalTrials.gov Archive Site
Metastatic development using CT scan [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
To study the pharmacokinetics of OGF when given chronically by examining blood OGF levels before and during the infusions. Elucidate the effects of OGF on the quality of life, pain control and depression in patients with advanced head and neck cancer by [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Pharmacokinetics of OGF [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
Not Provided
 
Treatment of Advanced Head and Neck Cancer
Treatment of Advanced Head and Neck Cancer With Opioid Growth Factors: Phase II

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Squamous Cell of Head and Neck
Biological: Opioid Growth Factor
250ug per kilogram weekly IV infusions
Other Names:
  • endogenous opioid peptide
  • Met-enkephalin
Experimental: Single Arm
Opioid Growth Factor (OGF)
Intervention: Biological: Opioid Growth Factor

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00982696
PSU 23429
Yes
David Goldenberg, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Not Provided
Principal Investigator: David Goldenberg, MD Penn State College of Medicine
Milton S. Hershey Medical Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP