Phase I Study in Advanced Malignancies With 5-ALA
- Registration Number
- NCT04381806
- Lead Sponsor
- Fox Chase Cancer Center
- Brief Summary
RDT aims to take advantage of the relatively safer toxicity profiles of both lower dose radiation therapy and systemic ALA to treat non-superficial lesions in a manner similar to photodynamic therapy. The doses of radiation administered in this study will be lower than those typically used to treat cancer. However, with administration of ALA, which has been shown to be selectively concentrated in neoplastic cells, it is reasonable to expect responses in the target lesion(s) with relative sparing of nearby normal structures. A similar therapy is currently being used in a single institution in China. Members of the Fox Chase Cancer Center have visited the Chinese medical site multiple times and have gained first-hand experience with this therapy. Based on thus-far unpublished data, this treatment appears to be both safe and well-tolerated. There have been marked responses seen in some of these patients, but this therapy has not yet been investigated in a more formalized clinical trial setting, nor has it been used on Western patients. Thus, while these findings are encouraging, much work is necessary to determine the efficacy and role of this intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 5-ALA 5-ALA orally-administered 5-aminolevulinic acid (ALA) given as a radiosensitizer prior to low-dose radiation therapy (RT)
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose 45 Days Determine the Maximum Tolerated Dose (MTD) of ALA and radiotherapy (RT) when administered concurrently.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States