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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.

Terminated

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

Official record
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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

Other trials in United States

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.

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.

  1. Toxicity as assessed by physical exam and laboratory data.

    Measured: weekly for 4 weeks and in week 6

  2. 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.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2001
  3. Primary completionDec 2005
  4. Study completionFeb 2006

Why it stopped: slow accrual

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
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

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.

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