Breast CancerPhase 1NCT00023790
Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin
A Phase 1 study testing silicon phthalocyanine 4 in people with Breast Cancer and Head and Neck Cancer, run by Case Comprehensive Cancer Center 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. This may be effective treatment for skin cancer and cancer that is metastatic to the skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Head and Neck Cancer, Lymphoma
- What is being tested?
- silicon phthalocyanine 4
- Type of treatment
- Injection or infusion
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Feb 2006
- 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 tumor for which no potential curative therapy exists (e.g., surgery, radiotherapy, or systemic chemotherapy)
- The following tumor types are eligible:
- Cutaneous nodular metastatic breast carcinoma lesion with loco-regional cutaneous, soft tissue, or chest wall involvement
- No chest wall recurrence without prior radiotherapy
- Other metastatic sites allowed provided patient is concurrently receiving hormonal therapy or trastuzumab (Herceptin) of at least 4 weeks duration
- Cutaneous or superficial subcutaneous nodular metastatic head and neck lesion
- Cutaneous nodular Kaposi's sarcoma lesion
- Stage IA-IIB or IVA cutaneous T-cell lymphoma (CTCL)
- CTCL patches, plaques, or tumors with a surface area of up to 25 cm^2 if other areas of involved skin are blocked from therapy
- Squamous cell or basal cell carcinoma of the skin that is not eligible for standard therapy (e.g., cryosurgery, radiotherapy, electrodesiccation and curettage, or excision)
- Cutaneous and subcutaneous metastasis from any solid tumor (e.g., thoracic, gastrointestinal, or genitourinary cancers or sarcomas)
- Bidimensionally measurable disease
- No more than 2 lesions may be treated
- No single area greater than 36 cm^2 may be treated (maximum of 25 cm^2 tumor mass with a 1 cm margin)
- Tumor treatable by surface (non-contact) light illumination
- Skin type I-III
- No tumors of the eyelids
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Hemoglobin at least 9 g/dL
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST/ALT no greater than 2 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2 times ULN
- No history of hepatic cirrhosis
- No hepatic disease requiring therapy
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 50 mL/min
- No renal disease requiring therapy
Cardiovascular:
- No myocardial infarction within the past 6 months
- No significant congestive heart failure requiring therapy
- No peripheral vascular disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Antinuclear antibody negative
- No sepsis
- No prior allergic or hypersensitivity reaction to paclitaxel vehicle
- No known photosensitivity diseases such as porphyria, systemic lupus erythematosus, xeroderma pigmentosum, or polymorphous light eruption
- No symptomatic collagen vascular disease
- Insulin-dependent or adult-onset diabetes mellitus allowed provided there are no lower extremity lesions
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 4 weeks since prior immunotherapy
- No concurrent immunotherapy
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior systemic chemotherapy
- No concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- No concurrent corticosteroids
Radiotherapy:
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy
- More than 4 weeks since prior ultraviolet B light therapy or psoralen-ultraviolet light therapy to non-study lesions/areas
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 5 days since prior warfarin
- At least 4 weeks since prior investigational drugs
- At least 4 weeks since prior local therapy to study lesions
- At least 6 months since prior photodynamic therapy
- No concurrent aspirin, aspirin-containing medications, or non-steroidal anti-inflammatory drugs (e.g., ibuprofen, indomethacin, or cyclo-oxygenase [COX]-1 and COX-2 inhibitors)
- No other concurrent photosensitizing medications such as tetracyclines, psoralens, nalidixic acid, griseofulvin, sulfa drugs, hydrochlorothiazide, furosemide, phenothiazines, or amiodarone
- No concurrent therapeutic dosages of warfarin (non-therapeutic dosages allowed)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Phase I Trial of PC 4-PDT (NSC 676418) for Cutaneous Malignancies
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for skin cancer and cancer that is metastatic to the skin.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy in treating patients who have either squamous cell or basal cell carcinoma of the skin or solid tumors metastatic to the skin.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of silicon phthalocyanine 4 (Pc 4) when administered with a fixed dose of light in patients with advanced cutaneous malignancies.
- Determine the MTD of the light when administered with a fixed dose of study drug in these patients.
- Determine the pharmacokinetics of Pc 4 in these patients.
- Determine the clinical antitumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive silicon phthalocyanine 4 (Pc 4) IV over 2 hours on day 1 followed by light therapy over 30-60 minutes on day 2. Treatment repeats in 6 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of Pc 4 and a fixed dose of light until the maximum tolerated dose (MTD) of Pc 4 is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD for Pc 4 is determined, additional patients are treated with a fixed dose of Pc 4 (2 dose levels below the MTD) and escalating doses of light until the MTD is determined. The MTD of light is defined as above.
Patients are followed at 6 weeks (or 8 weeks if treated lesion on lower extremity has not healed) and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study annually.
- Conditions
- Breast Cancer, Head and Neck Cancer, Lymphoma, Metastatic Cancer, Non-melanomatous Skin Cancer, Sarcoma
- Being tested
- silicon phthalocyanine 4
- Keywords
- stage IV breast cancer, recurrent breast cancer, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, recurrent skin cancer, classic Kaposi sarcoma, immunosuppressive treatment related Kaposi sarcoma, AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV verrucous carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Lymphoma, Neoplasm Metastasis, Sarcoma, Lymphoma, T-Cell, Cutaneous, Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silicon phthalocyanine 4Drug
Also called Pc-4 (Silicone phthalocyanine)
Patients receive silicon phthalocyanine 4 (Pc 4) IV over 2 hours on day 1 followed by light therapy over 30-60 minutes on day 2. Treatment repeats in 6 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of Pc 4.
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity as assessed by physical exam and laboratory data.
Measured: weekly for 4 weeks and in week 6
Disease response as measured by skin assessment and photography
Measured: weekly for 4 weeks and in week 6
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 startAug 2001
- Primary completionDec 2005
- Study completionFeb 2006
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Scot C. Remick, MD, Study chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023790
- Sponsor's protocol ID
- CWRU1Y97
- Other IDs
- U01CA062502, P30CA043703, CWRU-1Y97, NCI-T99-0007, CASE-1Y97
- Status last verified
- Aug 2011
- First submitted
- 13 Sep 2001
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of PC 4-PDT (NSC 676418) for Cutaneous Malignancies
- ClinicalTrials.gov ID
- NCT00023790
- Acronym / sponsor ID
- CWRU1Y97
- Conditions
- Breast Cancer, Head and Neck Cancer, Lymphoma, Metastatic Cancer, Non-melanomatous Skin Cancer, Sarcoma
- Keywords
- stage IV breast cancer, recurrent breast cancer, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2001
- Primary completion
- Dec 2005 (actual)
- Study completion
- Feb 2006 (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. This may be effective treatment for skin cancer and cancer that is metastatic to the skin.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy in treating patients who have either squamous cell or basal cell carcinoma of the skin or solid tumors metastatic to the skin.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of silicon phthalocyanine 4 (Pc 4) when administered with a fixed dose of light in patients with advanced cutaneous malignancies.
- Determine the MTD of the light when administered with a fixed dose of study drug in these patients.
- Determine the pharmacokinetics of Pc 4 in these patients.
- Determine the clinical antitumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive silicon phthalocyanine 4 (Pc 4) IV over 2 hours on day 1 followed by light therapy over 30-60 minutes on day 2. Treatment repeats in 6 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of Pc 4 and a fixed dose of light until the maximum tolerated dose (MTD) of Pc 4 is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD for Pc 4 is determined, additional patients are treated with a fixed dose of Pc 4 (2 dose levels below the MTD) and escalating doses of light until the MTD is determined. The MTD of light is defined as above.
Patients are followed at 6 weeks (or 8 weeks if treated lesion on lower extremity has not healed) and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study annually.
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 |
|---|---|---|
| silicon phthalocyanine 4Also: Pc-4 (Silicone phthalocyanine)Patients receive silicon phthalocyanine 4 (Pc 4) IV over 2 hours on day 1 followed by light therapy over 30-60 minutes on day 2. Treatment repeats in 6 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of Pc 4. | Drug | – |
Primary outcome
Toxicity as assessed by physical exam and laboratory data.
Time frame: weekly for 4 weeks and in week 6
Disease response as measured by skin assessment and photography
Time frame: weekly for 4 weeks and in week 6
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2011.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink 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.
Scot C. Remick, MD study chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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 silicon phthalocyanine 4 in people with Breast Cancer and Head and Neck Cancer, run by Case Comprehensive Cancer 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?
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 24 Aug 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 was stopped early (reason given: slow accrual). 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?
Toxicity as assessed by physical exam and laboratory data. (time frame: weekly for 4 weeks and in week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 24 Aug 2011.