Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT00028405
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00028405
Study Brief:
Protocol Section:
NCT00028405