Treatment of Advanced Head and Neck Cancer

Carcinoma, Squamous Cell of Head and Neck Clinical Trial

Official title:

Treatment of Advanced Head and Neck Cancer With Opioid Growth Factors: Phase II

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00982696
• Other study ID #: PSU 23429
• Status: Terminated
• Phase: Phase 2
• First received: September 22, 2009
• Last updated: September 18, 2014
• Start date: February 2008
• Est. completion date: November 2011

Study information

• Verified date: September 2014
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00905099

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Carcinoma, Squamous Cell of Head and Neck
• Head and Neck Neoplasms

Intervention

Biological:
• Opioid Growth Factor
250ug per kilogram weekly IV infusions

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Wybran J, Schandené L, Van Vooren JP, Vandermoten G, Latinne D, Sonnet J, De Bruyère 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. — View 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. Erratum in: Brain Res 1989 Oct 2;498(2):405. — View Citation

Zagon IS, McLaughlin PJ. Opioid antagonists inhibit the growth of metastatic murine neuroblastoma. Cancer Lett. 1983 Nov;21(1):89-94. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetics of OGF		every 4 weeks	No
Primary	Progression of tumor measured with CT scan		every 3 months	Yes
Secondary	Metastatic development using CT scan		every 3 months	Yes

External Links

•   Penn State Hershey Cancer Institute