Non-melanomatous Skin CancerPhase 1NCT00017485
Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer
A Phase 1 study testing HPPH in people with Non-melanomatous Skin Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-melanomatous Skin Cancer
- What is being tested?
- HPPH
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Jan 2007
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed non-morpheaform basal cell skin cancer
- Primary disease OR
- Recurrent disease after prior therapy (e.g., surgical excision, electrodesiccation, cryosurgery, or radiotherapy)
- At least 4 lesions, no greater than 2 cm in diameter and no greater than 5 mm in depth
- No lesions located on the eyelid, nose, ear, periauricular area, genitals, or digits, or any other lesions thought to be deep and/or aggressive
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 2,000/mm^3
- Platelet count at least 120,000/mm^3
Hepatic:
- PT/PTT no greater than 1.5 times upper limit of normal (ULN)
- Bilirubin no greater than 3.0 mg/dL
- Liver enzymes no greater than 2 times ULN
- No impaired hepatic function
Renal:
- No impaired renal function
Cardiovascular:
- No myocardial infarction within the past 6 months
Other:
- No porphyria
- No known hypersensitivity to porphyrins
- No systemic lupus erythematosus
- No history of positive antinuclear antibody
- No history of degenerative disease of the retina
- No xeroderma pigmentosum
- No pancreatic disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 months since prior combination doxorubicin and radiotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- See Chemotherapy
Surgery:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: A Phase I Study Of Photodynamic Therapy (PDT) For The Treatment Of Basal Cell Carcinoma (BCC): A Drug/Light Dose Finding Study Utilizing 2-(1-HEXYLOXYETHYL)-2-DEVINYL PYROPHEOPHORBIDE-A (HPPH-PHOTOCLOR)
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have basal cell skin cancer.
Read the detailed description
OBJECTIVES:
- Determine the safety of HPPH used in photodynamic therapy in patients with basal cell skin cancer.
- Determine the drug dose, light dose, and treatment interval combinations that do not produce excessive toxicity to normal skin but effect tumor response in these patients treated with this regimen.
- Determine the length of time for cutaneous photosensitivity in these patients treated with this regimen.
- Determine the plasma clearance rates for HPPH in these patients.
- Determine the best combination of treatment parameters for a phase II study.
OUTLINE: This is a dose-escalation study.
Patients receive HPPH IV on day 1. Patients undergo phototherapy on days 2-3.
Cohorts of 2-6 patients receive escalating doses of HPPH and phototherapy to determine the minimum erythemal dose (MED). The MED is defined as the dose combination of HPPH and laser light preceding that at which at least 1 patient experiences grade 3 or worse toxicity or at which at least 2 patients experience grade 1 or worse toxicity.
Patients are followed daily for 4 days, at week 1, and at months 1, 3, 6, 12, and 24.
PROJECTED ACCRUAL: A total of 4-25 patients will be accrued for this study.
- Conditions
- Non-melanomatous Skin Cancer
- Being tested
- HPPH
- Keywords
- basal cell carcinoma of the skin, recurrent skin cancer
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPPHDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2000
- Primary completionDec 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanomatous Skin CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Allan R. Oseroff, MD, PhD, Study chair, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017485
- Sponsor's protocol ID
- CDR0000068696
- Other IDs
- P30CA016056, RPCI-DS-95-34, NCI-G01-1953
- Status last verified
- Mar 2011
- First submitted
- 6 Jun 2001
- Last updated
- 7 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Of Photodynamic Therapy (PDT) For The Treatment Of Basal Cell Carcinoma (BCC): A Drug/Light Dose Finding Study Utilizing 2-(1-HEXYLOXYETHYL)-2-DEVINYL PYROPHEOPHORBIDE-A (HPPH-PHOTOCLOR)
- ClinicalTrials.gov ID
- NCT00017485
- Acronym / sponsor ID
- CDR0000068696
- Conditions
- Non-melanomatous Skin Cancer
- Keywords
- basal cell carcinoma of the skin, recurrent skin cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2000
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have basal cell skin cancer.
Detailed description
OBJECTIVES:
- Determine the safety of HPPH used in photodynamic therapy in patients with basal cell skin cancer.
- Determine the drug dose, light dose, and treatment interval combinations that do not produce excessive toxicity to normal skin but effect tumor response in these patients treated with this regimen.
- Determine the length of time for cutaneous photosensitivity in these patients treated with this regimen.
- Determine the plasma clearance rates for HPPH in these patients.
- Determine the best combination of treatment parameters for a phase II study.
OUTLINE: This is a dose-escalation study.
Patients receive HPPH IV on day 1. Patients undergo phototherapy on days 2-3.
Cohorts of 2-6 patients receive escalating doses of HPPH and phototherapy to determine the minimum erythemal dose (MED). The MED is defined as the dose combination of HPPH and laser light preceding that at which at least 1 patient experiences grade 3 or worse toxicity or at which at least 2 patients experience grade 1 or worse toxicity.
Patients are followed daily for 4 days, at week 1, and at months 1, 3, 6, 12, and 24.
PROJECTED ACCRUAL: A total of 4-25 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HPPH | Drug | – |
Primary outcome
Not reported in the source record.
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 7 Mar 2011.
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.
Allan R. Oseroff, MD, PhD study chair
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?
A Phase 1 study testing HPPH in people with Non-melanomatous Skin Cancer, run by Roswell Park Cancer Institute 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?
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 7 Mar 2011. 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.
Where can I read the original study information?
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 7 Mar 2011.