Study Stopped
The patient was "lost to follow-up" and the PI left the institution.
Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers
1 other identifier
interventional
1
1 country
1
Brief Summary
Presently, there is no effective treatment for patients with advanced head and neck cancer (AHNC) that failed to respond to the standard therapy (radiation, chemotherapy and surgery) in the US. These patients are deemed incurable AHNC. In the European Union (EU), interstitial photodynamic therapy (I-PDT) with Temoporfin is approved for the treatment of patients with incurable AHNC. Well designed EU studies have shown that I-PDT with Temoporfin can provide worthwhile palliation by reducing tumor size, bleeding and pain in 53% - 60% of patients with incurable AHNC. This is a significantly higher rate in comparison to the reported response rate of palliative chemotherapy (6-30%). However, the EU studies did not correlate quantitative tumor response with clinical outcome. In addition, quality of life (QoL) improvements associated with I-PDT of AHNC using Temoporfin were also not evaluated. The objective of this study is to quantify the tumor response and patient's QoL to I-PDT with Temoporfin. Successfully meeting this objective will give us the tools the investigators need to design larger studies to significantly improve the management and QoL of patients with AHNC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 10, 2011
CompletedFirst Posted
Study publicly available on registry
August 12, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
December 3, 2012
CompletedDecember 3, 2012
November 1, 2012
9 months
August 10, 2011
May 11, 2012
November 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local Tumor Response to Interstitial Photodynamic Therapy (I-PDT) With Temoporfin
Longitudinal changes in tumor size (cm) and standardized uptake value (SUV) measured with Positron Emission Tomography - Computed Tomography (PET- CT).
Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment
Secondary Outcomes (1)
Changes in the Quality of Life (QoL)
Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment.
Study Arms (1)
Subjects receiving Temoporfin
EXPERIMENTALInterventions
A single dose of 0.15 mg of Temoporfin per kilogram of body weight will be administered by slow intravenous injection into a deep vein (such as the antecubital vein) in not less than 6 minutes.
Light dose of 20 J/cm, at a rate of 100 mW/cm, will be delivered to the target tumor and margins, within 200 seconds.
Eligibility Criteria
You may qualify if:
- years of age and older, male or female, of all races and ethnicities.
- Prior histologically confirmed advanced squamous cell carcinoma of the head and neck that failed standard therapy (radiation, chemotherapy, surgery).
- Must have a Karnofsky performance status higher than 70%.
- Measurable disease by PET-CT, defined as maximum SUV ≥4 in FDG for the tumor.
- Must have a discrete tumor that is accessible for unrestricted illumination of interstitial photodynamic therapy (I-PDT).
- Deemed unsuitable, by multidisciplinary tumor board, for curative treatment options such as radiotherapy, surgery, chemotherapy or a combination of these modalities. This will include patients who have exceeded the maximum radiation dose and are not candidates for re-irradiation.
- Deemed likely to survive for at least 6 months.
- Able and willing to provide written informed consent to participate in the study.
- If a female of childbearing potential, the subject is willing to take a pregnancy test and practice strict birth control (estrogen-containing oral contraceptives or an intrauterine device) throughout the study and for 3 months after Temoporfin administration. Women who have had a hysterectomy are exempt from these requirements.
- Must have blood glucose level below 250 (and preferably below 200) before FDG injection, required for PET-CT.
- Willing to remain in a light-avoidance environment for a time period of at least 15 days.
- Laboratory criteria:
- Hematocrit \>= 33%, hemoglobin \>= 11 g/dl
- Platelet count \>70.000 per microliter
- BUN: 7 to 20 mg/dL
- +9 more criteria
You may not qualify if:
- A tumor that is too close to a major blood vessel (such as the carotid artery).
- A tumor invading the skull base.
- The tumor is not clearly shown on the CT image.
- The location and extension of the tumor precludes an effective I-PDT.
- Pregnant or has uncontrolled hyperglycemia.
- Has porphyria or other diseases exacerbated by light.
- With hypersensitivity to Temoporfin or to any of its excipients.
- Has known allergies/hypersensitivity to porphyrins.
- Has known sensitivity to the CT contrast agent. (Omnipaque)
- Has poor renal function as demonstrated by serum creatinine and EGFR \<40, which would preclude the using of the CT contrast agent.
- Patient with a planned surgical procedure within the next 30 days.
- Has a coexisting ophthalmic disease likely to require slit-lamp examination within the next 30 days.
- Patient with existing therapy with a photosensitizing agent (Temoporfin, protoporphyrin or derivatives of porphyrin).
- Has received prior photodynamic therapy to the proposed treatment site within the prior 3 months.
- Has distant metastasis (with the exception of single stable distant metastasis that does not decrease life expectancy to less than 6 months).
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arkansaslead
- Erasmus Medical Centercollaborator
- The Netherlands Cancer Institutecollaborator
- Biolitec Pharma Ltd.collaborator
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Related Publications (1)
Lou PJ, Jager HR, Jones L, Theodossy T, Bown SG, Hopper C. Interstitial photodynamic therapy as salvage treatment for recurrent head and neck cancer. Br J Cancer. 2004 Aug 2;91(3):441-6. doi: 10.1038/sj.bjc.6601993.
PMID: 15238981BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small numbers of subjects analyzed.
Results Point of Contact
- Title
- Gal Shafirstein, D.Sc.
- Organization
- Roswell Park Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2011
First Posted
August 12, 2011
Study Start
November 1, 2010
Primary Completion
August 1, 2011
Study Completion
March 1, 2012
Last Updated
December 3, 2012
Results First Posted
December 3, 2012
Record last verified: 2012-11