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
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