Know Cancer

forgot password

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

Phase 1
18 Years
Not Enrolling
Breast Cancer, Skin Cancer

Thank you

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.


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

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:


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:


Principal Investigator

Roger Graham, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tufts Medical Center, Department of Surgery


United States: Federal Government

Study ID:

Komen Award ID# -BCTR0707871



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



Tufts Medical Center Boston, Massachusetts  02111