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Safety and Pharmacodynamic Study of a New Formulation, AGI - 101H Vaccine in the Treatment of Advanced Melanoma

NCT00716495 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-04-22

No results posted yet for this study

Summary

In this open-label study of patients with advanced melanoma 20 evaluable patients will be recruited.

The drug substance, AGI-101H, is a whole cell, allogeneic melanoma vaccine, representing a mixture (1:1 ratio) of two therapeutic gene modified human melanoma cell lines, referred to as Mich1H6 and Mich2H6, which has been gamma-irradiated to render the cells non-proliferative

Patients will receive treatment for up to 26 weeks. Progression at any time point requiring systemic treatment with, for example with chemotherapy or cytokines will lead to withdrawal of this patient from the study.

The dose chosen is 5 x 107 viable cells/dose.

Conditions

Interventions

BIOLOGICAL

AGI-101H Vaccine

Each patient will receive one dose of AGI - 101H containing 5 x 107 viable cells, administered s.c. for up to 26 weeks.

Sponsors & Collaborators

  • AGIRx Ltd.

    lead INDUSTRY

Principal Investigators

  • Margaret Gralinska · AGIRx (Active Gene Interventions) Ltd

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT00716495 on ClinicalTrials.gov