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A Multicenter Phase I Safety and Tolerability Study of the Oncolux System for Intratumoral Delivery of Non-Coherent Light for the Photoactivation of LS 11 in Patients With Refractory Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Liver Metastasis, Pelvic Cancer, Head and Neck Cancer, Sarcoma, Rectal Cancer, Breast Cancer, Colorectal Cancer, Mouth Cancer

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Trial Information

A Multicenter Phase I Safety and Tolerability Study of the Oncolux System for Intratumoral Delivery of Non-Coherent Light for the Photoactivation of LS 11 in Patients With Refractory Solid Tumors


In this Phase I photodynamic therapy study, patients will undergo a standard CT scan to
determine the suitability of the treatment. In those patients that qualify the entry
criteria, a light delivery catheter will be directly inserted in the tumor through a minor
surgical procedure. The patients will then be injected with the photosensitive drug, LS11.
One hour following the drug injection, light energy will be delivered from the light
delivery catheter for a period of 1-24 hours. The duration of the light treatment for a
given patient may be based on various factors including when a given patient enters the
study. Following the delivery of light energy, the light delivery catheter will be removed
from the tumor. The insertion and removal of the catheter will be carried out under the
guidance of CT scan. The patients will be asked to take precautions from external light
exposure for a period of time. The patients will undergo CT scan and other tests on days 7,
14 and 42 to evaluate safety of the treatment, tumor cell death and treatment response.
Blood samples will be taken at different time points to examine the clearance of the drug
from the body.


Primary

Inclusion Criteria:



- Target tumors accessible for percutaneous implantation under CT (and ultrasound if
needed) guidance in any superficial location, sarcoma, tumors of oral/oro-pharyngeal
cavity, tumors with extensive pelvic involvement, or liver metastasis.

- Patient has failed prior surgery or chemotherapy or radiation therapy and the tumor
is refractory.

- Tumor mass is not immediately adjacent to, or directly invading a major vessel or
hollow viscus such that tumor necrosis could result in hemorrhage or perforation.

- Patient has not received prior chemotherapy for at least 4 weeks and patient has
recovered from toxicity.

- Patient has an ECOG performance status of 0-3 (Karnofsky 30 or higher).

- If patients have received radiotherapy to sites of disease other than the one planned
for insertion of the light delivery catheter, then the patient must have no current
local or systemic toxicity from the prior radiation.

- Patient has recovered from all previous surgery in the judgment of the Principal
Investigator.

- Patient has not been treated with any biologics (excluding hormones) at least 4 weeks
prior to the screening and patient has recovered from any toxicity.

- Age 18 or older.

- Minimum life expectancy of 12 weeks.

- Ability to provide informed consent.

- All tumors must:

- have a minimum dimension that exceeds 4 x 2.8 cm;

- have a shape and location such that the mid-point on the light delivery catheter
will be greater than 2.0 cm from any structure which, if damaged by PDT
treatment, would result in pain or injury to the patient.

Exclusion Criteria:

- History of cardiovascular abnormalities, including, myocardial infarction in the last
6 months, arrhythmias, uncontrolled congestive heart failure;

- History of ongoing, significant active medical illness that might create a risk for
the patient, in the opinion of the Investigator;

- History of known or suspected porphyria;

- Concomitant use of other drugs known to produce skin photosensitivity;

- Women who are pregnant or lactating;

- Hematopoietic abnormalities from the baseline examination, as evidenced by the
following laboratory values (US Units):Hemoglobin <10 g/dL; White blood cell (WBC)
count <2500/mm3;Neutrophil count < or = 1500/uL;Platelet count < or = 100,000/mm3;

- Renal or liver function abnormalities from the baseline examination, as evidenced by
the following laboratory values(US Units):Serum Creatinine >2.0 mg/dL;Total bilirubin
> 2.0 mg/dL; SGOT (AST) > 3x the ULN;SGPT (ALT) > 3x the ULN; GGT> 3x the ULN

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jay Winship, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sr. Vice President of R & D and Chief Medical Officer

Authority:

United States: Food and Drug Administration

Study ID:

LSC-OL001

NCT ID:

NCT00028405

Start Date:

November 2001

Completion Date:

December 2002

Related Keywords:

  • Liver Metastasis
  • Pelvic Cancer
  • Head and Neck Cancer
  • Sarcoma
  • Rectal Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Mouth Cancer
  • Photodynamic Therapy
  • Bulky Tumor
  • Refractory Tumor
  • Head and Neck Cancer
  • Breast Cancer
  • Pelvic Tumors
  • Liver Metastasis
  • Colorectal Cancer
  • Sarcoma
  • Anal Cancer
  • Oral Cancer
  • Recurrent
  • Lymphadenopathy
  • Ovarian Cancer
  • Cervical Cancer
  • Breast Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Mouth Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms
  • Pelvic Neoplasms
  • Sarcoma

Name

Location

Virginia Mason Medical CenterSeattle, Washington  98111
University of Arizona, VA Medical CenterTucson, Arizona  85723
Detroit Medical Center, Wayne State UniversityDetroit, Michigan  48201
East Carolina State University, Brody School of MedicineGreenville, North Carolina  27858
Albert Einstein Medical CenterPhiladelphia, Pennsylvania  19141
University of Pennsylvania School of MedicinePhiladelphia, Pennsylvania  19104