Basal Cell Carcinoma of the SkinPhase 1NCT01292668

Photodynamic Therapy Using Methyl-5-Aminolevulinate Hydrochloride Cream in Determining Pain Threshold in Patients With Skin Cancer

A Phase 1 study testing methyl-5-aminolevulinate hydrochloride cream, photodynamic therapy and laser therapy in people with Basal Cell Carcinoma of the Skin and Pain, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Basal Cell Carcinoma of the Skin, Pain, Recurrent Skin Cancer
What is being tested?: methyl-5-aminolevulinate hydrochloride cream, photodynamic therapy and laser therapy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Mar 2011to Sep 2014
Phase: Phase 1
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

Patients with 1-2 superficial basal cell carcinoma (sBCC), 0.5 to 2 cm in diameter
Primary or recurrent lesions may be treated
Diagnosis must be confirmed by biopsy, at least 2 weeks pre treatment
Each patient with < 8 lesions can contribute a maximum of 2 lesions per treatment session, 1 lesion per light source, which can be treated the same day as permitted by scheduling; the remaining lesions may be treated as soon as scheduling permits with non protocol Photodynamic Therapy
Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Who cannot join

Patients not meeting the above selection criteria
Lesions which are not suitable for diagnostic measurements
Patients with >= 8 lesions to be treated
Carcinomas of types known to have uncertain clinical margins (e.g. morpheaform or infiltrating), or any lesion felt to require Mohs surgery for definitive control
Lesions over boney prominences
Patients with porphyrias or known hypersensitivity to porphyrins

Show all 12Show fewer

Patients with known photosensitivity diseases
Patients with allergies to Metvixia (MAL) cream ingredients (peanut and almond oil)
Patients previously treated with a systemic photo sensitizer within 4 months
Pregnant or nursing female patients
Patients unwilling or unable to follow protocol requirements
Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug

Trial locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Cancer Institute
Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. Photodynamic therapy using methyl-5-aminolevulinate hydrochloride cream may be effective against skin cancer. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy with methyl-5-aminolevulinate hydrochloride cream in determining pain threshold patients with skin cancer

Read the detailed description

PRIMARY OBJECTIVES: I. To determine the "low" initial irradiance that causes no or minimal (pain grade of < 4) during the time period during which 90 +/- 10% photo bleaching of protoporphyrin IX (PplX) in the lesion occurs, and which precedes the "high" irradiance portion of MAL/PDT. II. To determine the effects of preceding "low" irradiance on the pain level of the "high" irradiance portion of MAL-PDT. SECONDARY OBJECTIVES: I. To determine the effects of irradiance on lesion perfusion. II. To determine PpIX and Total Vit D content in blood. TERTIARY OBJECTIVES: I. To monitor the clinical outcomes of the treatments for initial response and recurrences. OUTLINE: Patients are randomized to 1 of 2 treatment arms. GROUP I: Patients apply methyl-5-aminolevulinate hydrochloride (MAL) cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo laser light treatment for 3-5 minutes. GROUP II: Patients apply MAL cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo light-emitting diode treatment for 10-20 minutes. After completion of study treatment, patients are followed up at 5-7 days, at 6-12 months, and at 24 months.

Conditions: Basal Cell Carcinoma of the Skin, Pain, Recurrent Skin Cancer
Being tested: methyl-5-aminolevulinate hydrochloride cream, photodynamic therapy, laser therapy
Medical subject headings: Carcinoma, Basal Cell, Pain, Skin Neoplasms

What participants receive

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

methyl-5-aminolevulinate hydrochloride creamDrug
Also called Metvix cream, Metvixia cream
Applied topically
photodynamic therapyDrug
Also called Light Infusion Therapy™, PDT, therapy, photodynamic
Undergo light-emitting diode photodynamic therapy
laser therapyProcedure or surgery
Also called therapy, laser
Undergo laser light photodynamic therapy

Study groups in NCT01292668
Study group	Role	What they receive
Group I	Experimental	Patients apply methyl-5-aminolevulinate hydrochloride (MAL) cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo laser light treatment for 3-5 minutes. Receives: Drug: methyl-5-aminolevulinate hydrochloride cream; Procedure: laser therapy
Group II	Experimental	Patients apply MAL cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo light emitting diode treatment for 5-10 minutes. Receives: Drug: methyl-5-aminolevulinate hydrochloride cream; Drug: photodynamic therapy

What is being measured

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

Irradiance-dependent pain threshold
Measured: 30-60 sec after the initial "low" irradiance treatment, every 3-5 min until irradiance increase, 30-60 sec after the "high" irradiance increase, and every 3-5 min until end of treatment

Secondary outcomes (1)

Efficacy of treatment in terms of clinical response
Measured: At 5-7 days, at 6-12 months, and at 24 months

Timeline

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

Mar 2011Sep 2014

First posted9 Feb 2011 (estimated)
Study startMar 2011
Primary completionJul 2012
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Basal Cell Carcinoma of the SkinStudies of the same condition, open and under way.
More trials run by Roswell Park Cancer InstituteThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01292668
Sponsor's protocol ID: I 175410
Other IDs: NCI-2010-02319
Status last verified: Sep 2014
First submitted: 8 Feb 2011
Last updated: 29 Sep 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Basal Cell Carcinoma of the Skin trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.
ClinicalTrials.gov ID: NCT01292668
Acronym / sponsor ID: I 175410
Conditions: Basal Cell Carcinoma of the Skin, Pain, Recurrent Skin Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Roswell Park Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Mar 2011
Primary completion: Jul 2012 (actual)
Study completion: Sep 2014 (actual)
First posted: 9 Feb 2011 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group I	Experimental	Drug: methyl-5-aminolevulinate hydrochloride cream, Procedure: laser therapyPatients apply methyl-5-aminolevulinate hydrochloride (MAL) cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo laser light treatment for 3-5 minutes.
Group II	Experimental	Drug: methyl-5-aminolevulinate hydrochloride cream, Drug: photodynamic therapyPatients apply MAL cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo light emitting diode treatment for 5-10 minutes.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients with 1-2 superficial basal cell carcinoma (sBCC), 0.5 to 2 cm in diameter
Primary or recurrent lesions may be treated
Diagnosis must be confirmed by biopsy, at least 2 weeks pre treatment
Each patient with < 8 lesions can contribute a maximum of 2 lesions per treatment session, 1 lesion per light source, which can be treated the same day as permitted by scheduling; the remaining lesions may be treated as soon as scheduling permits with non protocol Photodynamic Therapy
Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Key exclusion criteria (12 listed)

Patients not meeting the above selection criteria
Lesions which are not suitable for diagnostic measurements
Patients with >= 8 lesions to be treated
Carcinomas of types known to have uncertain clinical margins (e.g. morpheaform or infiltrating), or any lesion felt to require Mohs surgery for definitive control
Lesions over boney prominences

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
methyl-5-aminolevulinate hydrochloride creamAlso: Metvix cream, Metvixia creamApplied topically	Drug	Group I, Group II
photodynamic therapyAlso: Light Infusion Therapy™, PDT, therapy, photodynamicUndergo light-emitting diode photodynamic therapy	Drug	Group II
laser therapyAlso: therapy, laserUndergo laser light photodynamic therapy	Procedure or surgery	Group I

Primary outcome

Irradiance-dependent pain threshold
Time frame: 30-60 sec after the initial "low" irradiance treatment, every 3-5 min until irradiance increase, 30-60 sec after the "high" irradiance increase, and every 3-5 min until end of treatment

1 secondary outcome

Efficacy of treatment in terms of clinical response
Time frame: At 5-7 days, at 6-12 months, and at 24 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2014.

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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.

Ilene L Rothman, MD principal investigator

Roswell Park Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 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: finished, as of the sponsor's last update on 29 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Irradiance-dependent pain threshold (time frame: 30-60 sec after the initial "low" irradiance treatment, every 3-5 min until irradiance increase, 30-60 sec after the "high" irradiance increase, and every 3-5 min until end of 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 NCT01292668.

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 29 Sep 2014.