Clinical trial · Interventional
Treatment of Advanced Head and Neck Cancer
Treatment of Advanced Head and Neck Cancer With Opioid Growth Factors: Phase II
NCT00982696CI-TRIAL-00015732terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Deemed ineffective
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell of Head and Neck | Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Opioid Growth Factor | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Opioid Growth Factor (OGF)
- interventionNames
- Biological: Opioid Growth Factor
Primary outcomes (1)
- measure
- Progression of tumor measured with CT scan
- timeFrame
- every 3 months
Secondary outcomes (1)
- measure
- Metastatic development using CT scan
- timeFrame
- every 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDZagon 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. PMID 2758319
- BACKGROUNDWybran 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. PMID 3496822
- BACKGROUNDZagon 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. PMID 6640516
- BACKGROUNDGoldenberg 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. PMID 19014324