Carcinoma, Squamous Cell of Head and NeckPhase 2NCT00982696
Treatment of Advanced Head and Neck Cancer
A Phase 2 study testing Opioid Growth Factor in people with Carcinoma, Squamous Cell of Head and Neck, run by Milton S. Hershey Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell of Head and Neck
- What is being tested?
- Opioid Growth Factor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
Read the 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.
- Being tested
- Opioid Growth Factor
- Keywords
- head and neck cancer, opioid growth factor
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Growth FactorBiological
Also called endogenous opioid peptide, Met-enkephalin
250ug per kilogram weekly IV infusions
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Opioid Growth Factor (OGF) Receives: Biological: Opioid Growth Factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of tumor measured with CT scan
Measured: every 3 months
Secondary outcomes (1)
Metastatic development using CT scan
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startFeb 2008
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Deemed ineffective
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Squamous Cell of Head and NeckStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Goldenberg, Milton S. Hershey Medical Center
- Investigators
- David Goldenberg, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982696
- Sponsor's protocol ID
- PSU 23429
- Status last verified
- Sep 2014
- First submitted
- 22 Sep 2009
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 2758319Wybran 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.
PubMed 3496822Zagon 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.
PubMed 6640516Goldenberg 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.
PubMed 19014324
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Advanced Head and Neck Cancer With Opioid Growth Factors: Phase II
- ClinicalTrials.gov ID
- NCT00982696
- Acronym / sponsor ID
- PSU 23429
- Keywords
- head and neck cancer, opioid growth factor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Deemed ineffective
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Biological: Opioid Growth FactorOpioid Growth Factor (OGF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid Growth FactorAlso: endogenous opioid peptide, Met-enkephalin250ug per kilogram weekly IV infusions | Biological | Single Arm |
Primary outcome
Progression of tumor measured with CT scan
Time frame: every 3 months
1 secondary outcome
Metastatic development using CT scan
Time frame: every 3 months
Results and safety
The study was stopped early (reason given: Deemed ineffective). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
- Background: PubMed 2758319Zagon 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.
- Background: PubMed 3496822Wybran 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.
- Background: PubMed 6640516Zagon 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.
- Background: PubMed 19014324Goldenberg 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.
- Penn State Hershey Cancer InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Goldenberg, MD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Opioid Growth Factor in people with Carcinoma, Squamous Cell of Head and Neck, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Deemed ineffective). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of tumor measured with CT scan (time frame: every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00982696, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014.