Study Summary

This study is being conducted to determine the dose of investigational agent aminolevulinic acid (ALA) that could be safely administered concurrently with radiation therapy. This is known as Radiodynamic Therapy (RDT). ALA is approved by the FDA for treatment of other cancers. The radiation in this study is generated by a device called a Microtron, and the radiation administered in this study is lower than doses typically used to treat cancer. It is being used to activate the ALA inside the tumor to damage it. We do not know if you will benefit from this research study. It is possible that your condition will get better, but it is also possible that there will be no effect on your condition or that your condition will get worse.

Up to 130 people will take part in this research study. The sponsor-investigator of this study is Anthony J Olszanski, MD, RPh, at Fox Chase Cancer Center. The study is supported by Fox Chase Cancer Center.

The study drug ALA is administrated orally on day 1, 8 and 15 followed directly by radiation treatment and admission to the hospital overnight, to minimize the risk of exposure to strong light (light can activate ALA and cause a sunburn-like reaction). Patients are discharged after each overnight stay.

Protocol: 20-1009 / IRB20-1009
Phase: I
Investigator: Anthony Olszanski, MD, RPh
Disease(s): Any solid tumor with the exception of CNS tumors or those in or abutting the spine

Full Title: A Phase I Dose Finding Study of Low-dose Radiation with Sensitization Using 5-aminolevulinic Acid in Advanced Malignancies Phase I Study with 5-aminolevulinic Acid in Advanced Malignancies

ClinicalTrials.gov
Visit ClinicalTrials.gov for a full clinical trial description.

Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Diagnosis: a. Patients must have a histologically and/or cytologically confirmed primary solid tumors b. Lesion(s) (target or non-target) must be evaluable by PET or MRI c. Radiographic or clinical evidence of advanced/metastatic disease that is: i. Resistant to standard therapy or for which no standard therapy is available.
• Patient must be a candidate for, and be able to undergo PET/MRI imaging a. Patients who refuse MRI imaging are not eligible b. Patients who cannot undergo PET/MRI imaging will be deemed screen failures. Rescreening once is permissible if the investigator feels that appropriate premedications may allow successful imaging.
• Patients must be able to take enterally-administered medications. Patients must not have any clinical evidence of impaired gastrointestinal function or any gastrointestinal disease that may significantly alter the absorption of ALA, in the opinion of the treating investigator.
• Patients must not be undergoing phototherapy for another, non-oncologic or oncologic disease (e.g. PUVA therapy or photodynamic therapy for skin diseases).

For more information about this and other studies and to inquire about eligibility, please call 215-214-1515.