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Squamous Cell Carcinoma of the Head and NeckPhase 2NCT01415986

Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers

A Phase 2 study testing Temoporfin and Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH) in people with Squamous Cell Carcinoma of the Head and Neck, run by University of Arkansas at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 95 years
What is being tested?
Temoporfin and Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Nov 2010to Mar 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 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.
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  • 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
  • CO2 (carbon dioxide): 20 to 29 mmol/L
  • Creatinine: 0.8 to 1.4 mg/dL
  • Glucose: 64 to 128 mg/dL
  • Serum chloride: 101 to 111 mmol/L
  • Serum potassium: 3.7 to 5.2 mEq/L
  • Serum sodium: 136 to 144 mEq/L
  • Liver function test: albumin, bilirrubin (direct/conjugated), ALT (alanine transaminase), AST (aspartate transaminade), GGT (gamma glutamyl transferase), ALP (alkaline phosphatase) within normal limits
  • White blood count > 3,000 per microliter or ANC > 1500 per microliter
  • Serum calcium within normal limits.

Who cannot join

  • 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.
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  • 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).
  • Has a childbearing potential and will not use adequate contraceptive protection.
  • A female that is breastfeeding.
  • Patient of childbearing potential who has a positive (+) urine pregnancy test.
  • Received treatment with an experimental drug or entered another clinical trial within the prior 30 days.
  • Received radiotherapy to the head and neck region within the prior 3 months.
  • Any disease, which is caused or exacerbated by light, including systemic lupus erythematosus, psoriasis, porphyria, actinic reticuloid or xeroderma pigmentosum.
  • Has been treated within the prior 30 days with a light-activated therapy or other medication that may render the subject photosensitive (e.g., psoralen ultraviolet A-range [PUVA], Accutane, 5-Fluorouracil, tetracycline's ).
  • Not willing or able to complete the visit requirements of this protocol or adhere to the instructions regarding light exposure.
  • Any other condition that the PI staff feels will be an endangerment to the subject.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers - PHASE II PILOT STUDY

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.

Read the detailed description

This is a non-randomize, open label, Pilot phase II study with 5 consenting subjects. The specific aims of this study are:

Aim 1: Quantitate local tumor response in patients with incurable AHNC treated with I-PDT with Temoporfin.

Aim 2: Evaluate the changes in QoL in patients with incurable AHNC treated with I-PDT with Temoporfin.

Being tested
Temoporfin, Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH)
Keywords
Advanced head and neck cancer, Squamous cell carcinoma, SCC, HNSCC
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TemoporfinDrug

    Also called Foscan

    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.

  • Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH)Device

    Also called Ceralas PDT 652, CeramOptec GmbH

    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.

Study groups in NCT01415986
Study groupRoleWhat they receive
Subjects receiving TemoporfinExperimentalNot described
Receives: Drug: Temoporfin; Device: Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment

Secondary outcomes (1)

  1. Changes in the Quality of Life (QoL)

    The change in the overall score of the University of Washington quality of life questionnaire (UW-QOL). Each of the domain-specific items is scored from 0 (worst quality of life (QOL) to 100 (Best QOL). The composite score is created by averaging the scores.

    Measured: Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2011 (estimated)
  2. Study startNov 2010
  3. Primary completionAug 2011
  4. Study completionMar 2012

Why it stopped: The patient was "lost to follow-up" and the PI left the institution.

Resources

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01415986
Sponsor's protocol ID
UAMS IRB 114294
Status last verified
Nov 2012
First submitted
10 Aug 2011
Last updated
3 Dec 2012
Data monitoring committee
No

Publications

  • 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.

    PubMed 15238981

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temoporfin and Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH) in people with Squamous Cell Carcinoma of the Head and Neck, run by University of Arkansas 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 24 inclusion and 24 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 3 Dec 2012. 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?

Yes. Results are posted in the registry (first posted 3 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Local Tumor Response to Interstitial Photodynamic Therapy (I-PDT) With Temoporfin (time frame: Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment). 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 NCT01415986, which also lists 1 linked publication.

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 3 Dec 2012.

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