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A Phase I Trial of Continuous Low-Irradiance Photodynamic Therapy (CLIPT) for Patients Failing Radiation Therapy


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Skin Cancer

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Trial Information

A Phase I Trial of Continuous Low-Irradiance Photodynamic Therapy (CLIPT) for Patients Failing Radiation Therapy


The goal of this research is to conduct a Phase I clinical study to assess the toxicity,
safety and feasibility of a novel cancer treatment, Continuous Low Irradiance Photodynamic
Therapy (CLIPT). This research will provide translation of recent promising preclinical work
to human subjects with recurrent breast cancer.

BACKGROUND: Patients who develop post-mastectomy chest wall skin recurrence and fail
conventional radiation therapy have few therapeutic options that can result in durable
control. High-irradiance photodynamic therapy (PDT) has shown efficacy in patients with
chest-wall progression of breast cancer that have failed radiation, surgery, and
chemotherapy. However its clinical application has been severely limited as currently
employed methods of PDT result in virtually 100% of patients develop skin necrosis, large
areas of full-thickness ulceration, slow healing and chronic wound pain. In the rat and
rabbit-brain tumor models, reducing the laser irradiance and increasing the exposure time to
achieve a similar total fluence (fluence = irradiance x time) to standard PDT, avoids tissue
necrosis while inducing apoptosis in the tumor but not normal tissue.

HYPOTHESIS: Low dose-rate (low irradiance) PDT may reduce or eliminate skin toxicity and
enables treatment of skin/subcutaneous chest wall metastases in skin previously subjected to
ionizing radiation.

SPECIFIC AIMS:

1) determine the fluence of CLIPT resulting in toxicity (maximum tolerated dose), defined as
ulceration or necrosis of previously irradiated skin (non-tumor bearing skin within the
prior ionizing radiation field) or normal skin, 2) evaluate the feasibility, ergonomics and
safety of performing CLIPT via a proprietary electronically targetable fiber-optic "patch"
placed directly on tumor-bearing, surrounding uninvolved previously irradiated skin and
normal integument 3) study the tumor-bearing integument for clinical response to therapy by
measuring complete, partial and no response to CLIPT.

STUDY DESIGN: We will perform a standard dose (laser fluence) escalation trial (holding drug
level constant) in human subjects with post-mastectomy skin recurrences that have failed
ionizing radiation therapy and assess toxicity in previously irradiated and normal
integument.

POTENTIAL OUTCOMES & BENEFITS: Therapeutic options for post-mastectomy cutaneous recurrences
failing conventional radiotherapy are limited. If the pre-clinical results are replicated in
human subjects, Phase II studies to evaluate CLIPT would be warranted. The long-term goal is
to develop an unobtrusive, large-area CLIPT system in the form of a fiber-optically woven
"garment" that can be worn by the patient outside the hospital setting for repeated and
extended periods without causing skin breakdown or pain.


Inclusion Criteria:



- Patients > 18 years of age, with primary or metastatic cutaneous tumors that have
been previously irradiated.

- Patients must have a target lesion and normal peri-umbilical skin that can be covered
by the fiber-optic mesh used to deliver CLIPT (10 x 10 cm for Target lesion, and 1 x
1 cm for Control site).

- Patients must have a target lesion in a location other than the hands, feet,
genitals, or face. Lesions in those locations will be excluded.

- Patients must sign informed consent.

Exclusion Criteria:

- Patients must not have received any systemic anti-cancer therapy within 30 days prior
to enrolling in this study.

- Patients must not have received radiation therapy to the target site within 60 days
of enrolling on this study.

- Patients with medical conditions associated with photosensitivity, such as cutaneous
porphyria or a collagen vascular disease, or with known allergies to porphyrins will
be excluded.

- Pregnant and nursing patients will be excluded. Women of child-bearing potential
must have a negative serum or urine pregnancy test prior to enrollment.

- Patients taking medications known to cause photosensitivity (tetracyclines,
sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics,
griseofulvin, and fluoroquinolones) will be excluded.

- Laboratory values (Note: these are provided by the potential patient):

- Absolute neutrophil count > 1000.

- Patients with severe hepatic dysfunction (total bilirubin, AST, or ALT > five times
upper limit of normal) will be excluded.

- Adequate coagulation status as indicated by platelet count > 50,000, PT and PTT < 1.5
time the upper limit of normal.

- Negative Urine or Serum Pregnancy Test

Note: No cost to patient, and no compensation provided.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicity (full thickness ulceration and/or necrosis of the skin)

Outcome Time Frame:

48 hours to 7 days after treatment

Safety Issue:

Yes

Principal Investigator

Roger Graham, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tufts Medical Center, Department of Surgery

Authority:

United States: Federal Government

Study ID:

Komen Award ID# -BCTR0707871

NCT ID:

NCT00862901

Start Date:

January 2009

Completion Date:

April 2011

Related Keywords:

  • Breast Cancer
  • Skin Cancer
  • cancer
  • skin metastases
  • chest wall progression of breast cancer
  • malignant melanoma
  • photodynamic therapy
  • photophrin
  • satellite and in-transit metastases of malignant melanoma
  • skin cancer
  • Breast Neoplasms
  • Skin Neoplasms
  • Neoplasm Metastasis

Name

Location

Tufts Medical Center Boston, Massachusetts  02111