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Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors

NCT01455259 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-02-17

No results posted yet for this study

Summary

In this phase I/II trial, immunostimulatory gene therapy (AdCD40L) will be investigated. In Part 1 patients with melanoma will receive AdCD40L as mono therapy. In Part 2A, patients with melanoma and patients with other solid tumors will receive AdCD40L in combination with low dose cyclophosphamide. In Part 2B, patients with melanoma will receive AdCD40L in combination with one local radiotherapy and cyclophosphamide.

Conditions

  • Malignant Melanoma

Interventions

BIOLOGICAL

AdCD40L

Adenoviral serotype 5 vector, E1/E3 deleted. Human CD40L gene insert driven by RSV promoter. Vector diluted in infusion solution, 500uL solution containing 2.5x10e11 VP is intratumorally injected/treatment.

Sponsors & Collaborators

  • Uppsala University Hospital

    collaborator OTHER

  • Uppsala University

    lead OTHER

Principal Investigators

  • Thomas H Tötterman, MD, PhD · Uppsala University

  • Gustav Ullenhag, MD, PhD · Uppsala University Hospital

  • Angelica SI Loskog, PhD · Uppsala University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01455259 on ClinicalTrials.gov