NCT00235482

Brief Summary

The purpose of this study is to determine the safety of an injection of coxsackievirus A21 into a melanoma tumour, and also to see if there is a tumour response.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
29 days until next milestone

Study Start

First participant enrolled

November 8, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2006

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

October 7, 2005

Last Update Submit

June 26, 2019

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

  • Safety profile of treatment, characterisation of adverse events

Secondary Outcomes (1)

  • Efficacy - clinical response of injected and non-injected tumours

Interventions

Coxsackievirus A21DRUG

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stage IV melanoma (AJCC classification)
  • minimum of 2 sc metastases
  • failure or refusal of standard chemotherapy
  • ECOG score of 0 or 1
  • other

You may not qualify if:

  • metastatic CNS disease
  • ocular or mucosal melanoma
  • immunodeficiency
  • splenectomy
  • other

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melanoma Unit, Mater Misericordiae Hospital

Newcastle, New South Wales, 2298, Australia

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: CAVATAK
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 10, 2005

Study Start

November 8, 2005

Primary Completion

April 21, 2006

Study Completion

April 21, 2006

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations

AU(1)