Safety and Efficacy Study of DCVax-Direct in Solid Tumors

Phase 1

• Conditions: Colorectal Cancer; Pancreatic Cancer; Locally Advanced Tumor; Metastatic Solid Tissue Tumors; Liver Cancer; Melanoma
• Interventions: Biological: DCVax-Direct

• Registration Number: NCT01882946
• Lead Sponsor: Northwest Biotherapeutics

Brief Summary

The study comprises a Phase I component during which the optimal dose of DCVax-Direct for the treatment of solid tissue tumors will be identified, followed by a Phase II component to determine if the injection of DCVax-Direct into selected solid tissue tumors has the ability to reduce tumor growth.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-21
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-07
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCVax-Direct	DCVax-Direct	DCVax-Direct: autologous, activated dendritic cells for intratumoral injection

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	6 months

Secondary Outcome Measures

Name	Time	Method
Number of patients with tumor response	18 months

Trial Locations

Locations (2)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Orlando Health; 🇺🇸 Orlando, Florida, United States