NCT04381806

Phase I Study in Advanced Malignancies With 5-ALA

A Phase I Dose Finding Study Of Low-dose Radiation With Sensitization Using 5-aminolevulinic Acid In Advanced Malignancies

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Based on thus-far unpublished data, this treatment appears to be both safe and well-tolerated.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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	5-ALA	Patients enrolled in this study will receive 3 doses of ALA and fractions of radiation therapy during the course of one 21day cycle. Only one cycle per patient is allowed. Patients are followed through day 56 for adverse event and efficacy measures.

Timeline

• Start date: 2020-07-30
• Primary completion: 2026-02-01
• Completion: 2027-02-01
• First posted: 2020-05-11
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study