Clinical trial NCT00982696: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Squamous Cell of Head and Neck
Keywords: head and neck cancer
opioid growth factor
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression of tumor measured with CT scan
timeFrame: every 3 months
Secondary outcomes:
measure: Metastatic development using CT scan
timeFrame: every 3 months
Other outcomes:
measure: Pharmacokinetics of OGF
timeFrame: every 4 weeks
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: David Goldenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.