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Phase I Trial of PC 4-PDT (NSC 676418) for Cutaneous Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Head and Neck Cancer, Lymphoma, Metastatic Cancer, Non-melanomatous Skin Cancer, Sarcoma

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Trial Information

Phase I Trial of PC 4-PDT (NSC 676418) for Cutaneous Malignancies


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.

Inclusion Criteria


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)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity as assessed by physical exam and laboratory data.

Outcome Time Frame:

weekly for 4 weeks and in week 6

Safety Issue:

Yes

Principal Investigator

Scot C. Remick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU1Y97

NCT ID:

NCT00023790

Start Date:

August 2001

Completion Date:

February 2006

Related Keywords:

  • Breast Cancer
  • Head and Neck Cancer
  • Lymphoma
  • Metastatic Cancer
  • Non-melanomatous Skin Cancer
  • Sarcoma
  • 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
  • recurrent verrucous carcinoma of the oral cavity
  • recurrent mucoepidermoid carcinoma of the oral cavity
  • recurrent adenoid cystic carcinoma of the oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV inverted papilloma of the paranasal sinus and nasal cavity
  • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent inverted papilloma of the paranasal sinus and nasal cavity
  • recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
  • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • skin metastases
  • stage I mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • recurrent mycosis fungoides/Sezary syndrome
  • male breast cancer
  • Breast Neoplasms
  • Skin Neoplasms
  • Head and Neck Neoplasms
  • Lymphoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Sarcoma

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065