Condition category
Cancer
Date applied
08/04/2011
Date assigned
04/05/2011
Last edited
24/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Akseli Hemminki

ORCID ID

Contact details

Cancer Gene Therapy Group
University of Helsinki
Haartmaninkatu 8
Biomedicum B506b
Helsinki
00290
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ATAP

Study information

Scientific title

Open label oncolytic virus treatment of refractory cancer under the EU hospital exemption, article 28 of Regulation 1394/2007/EC

Acronym

ATAP

Study hypothesis

Oncolytic viruses as monotherapy and/or in combination with selected virus sensitizers or other cancer therapies are a safe treatment modality and may improve the quality of life and survival of patients with advanced cancer

As of 24/04/2012, anticipated end date of trial has been updated from 31/12/2019 to 31/03/2012.

Ethics approval

University of Helsinki Central Hospital Surgical Ethics Committee decided that since ATAP is a virus treatment program under EU hospital exemption and in that regard not a formal clinical trial, Ethics committee's approval is not required.

Study design

Personalized virus therapy for individual cancer patients with refractory solid tumors

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.docrates.com/images/stories/pdf/Potilasinformaatio_ja_suostumuslomake_30_Aug_2010.pdf (Finnish)
Not available in web format, please use the contact details below to request a patient information sheet (English)

Condition

Advanced solid tumors

Intervention

Personalized treatment with oncolytic viruses where the virus type, dose, dosing regimen, virus sensitizers, combination therapies and route of injection is optimized for each individual

Intervention type

Other

Phase

Phase II/III

Drug names

Primary outcome measures

1. Timepoints: Measured at baseline and at 3 months. However there is certain variability since each patient treatment is personalized and follow-up may be adjusted accordingly.
2. Methods:
2.1. RECIST 1.1
2.2. Modified PET Response Criteria in Solid Tumors
2.3. Applicable tumor markers from serum, depending on cancer type
2.4. Overall survival as days from first treatment

Secondary outcome measures

1. Safety
2. Adverse events
3. Overall Survival
4. Progression Free Survival
5. Imaging (PET, CT, MRI) based responses
6. Tumor marker responses
7. Symptomatic responses
8. Quality of life
9. Correlative biological data

Overall trial start date

12/11/2007

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Solid tumor cancer progressing after available routine therapies

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Ongoing treatment program with no pre-defined limits. Patients recruited from Finland and other countries.

Participant exclusion criteria

1. Known brain metastases
2. Recent thromboembolic event
3. Clinically significant active infection
4. Clinically significant medical condition considered high risk for experimental therapy (e.g. pulmonary, neurological, cardiovascular)
5. Severe or unstable cardiac disease
6. History of hepatic dysfunction
7. Cirrhosis or hepatitis
8. Women who are pregnant or nursing an infant
9. Previous organ transplant

Recruitment start date

12/11/2007

Recruitment end date

31/03/2012

Locations

Countries of recruitment

Finland

Trial participating centre

Cancer Gene Therapy Group
Helsinki
00290
Finland

Sponsor information

Organisation

Oncos Therapeutics Ltd (Finland)

Sponsor details

Saukonpaadenranta 2
Helsinki
00180
Finland

Sponsor type

Research organisation

Website

http://www.oncos.com

Funders

Funder type

Research organisation

Funder name

Oncos Therapeutics (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes