5-aminolevulinic Acid In Advanced Malignancies

Status Recruiting

Clinical Trial Summary

This is a phase 1, open label, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study to determine the maximum tolerated doses (MTD) or recommended phase 2 doses (RP2D) of both ALA and RT. Once the MTDs are identified, the cohort providing the highest dose intensity at or below the MTD (if supported by emerging PK and biomarker data) will be selected for an expansion phase for the purpose of refining the safety assessment and assessing preliminary efficacy. The initial dose escalation phase will enroll at least 20 patients across a variety of tumor types, after which concurrent disease site-specific expansion cohorts will accrue, each consisting of 20 patients. Anatomic site-specific cohorts will include patients with symptomatic metastatic disease to specific anatomic regions, where varying toxicity may be expected (Head and Neck, Thorax and Abdomen/Pelvis).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04443686
Study type	Interventional
Source	Fox Chase Cancer Center
Contact	Anthony Olszanski, MD
Phone	2152141676
Email	anthony.olsanski@fccc.edu
Status	Recruiting
Phase	Phase 1
Start date	July 30, 2020
Completion date	February 2027

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