Trial of Mistletoe Extract in Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: Helixor® M

• Registration Number: NCT03051477
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

This study will seek to determine the safety and toxicity profile as well as the maximum tolerated dose of Helixor® M in patients with advanced solid tumors.

Detailed Description

This study is a Phase I study that consists of two phases: a dose escalation phase and an expansion phase. The dose escalation phase will be used to evaluate the safety and toxicity of Helixor® M (mistletoe extract). An accelerated titration design (ATD) will be utilized to determine the MTD. The expansion phase will be used to obtain preliminary efficacy data about Helixor® M.

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-13
• Study Start: 2017-03-01
• Primary Completion: 2021-01-29
• Study Completion: 2022-08-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Helixor® M	Helixor® M	Advanced solid tumors

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing toxicities	3 years	Number of participants who experience side effects
Maximum tolerated dose (MTD)	2 years	The highest dose that does not cause unacceptable side effects

Secondary Outcome Measures

Name	Time	Method
Tumor marker kinetics	3 years	Changes in disease specific bio markers: analyzed as percent change and presented in a waterfall plot of response.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States