Advanced Therapy Access Program (ATAP): a treatment for refractory cancer with oncolytic viruses
| ISRCTN | ISRCTN10141600 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10141600 |
| Secondary identifying numbers | ATAP |
- Submission date
- 08/04/2011
- Registration date
- 04/05/2011
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Akseli Hemminki
Scientific
Scientific
Cancer Gene Therapy Group
University of Helsinki
Haartmaninkatu 8
Biomedicum B506b
Helsinki
00290
Finland
Study information
| Study design | Personalized virus therapy for individual cancer patients with refractory solid tumors |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant 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) |
| Scientific title | Open label oncolytic virus treatment of refractory cancer under the EU hospital exemption, article 28 of Regulation 1394/2007/EC |
| Study acronym | ATAP |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 12/11/2007 |
| Completion date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Ongoing treatment program with no pre-defined limits. Patients recruited from Finland and other countries. |
| Key inclusion criteria | Solid tumor cancer progressing after available routine therapies |
| Key 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 |
| Date of first enrolment | 12/11/2007 |
| Date of final enrolment | 31/03/2012 |
Locations
Countries of recruitment
- Finland
Study participating centre
Cancer Gene Therapy Group
Helsinki
00290
Finland
00290
Finland
Sponsor information
Oncos Therapeutics Ltd (Finland)
Research organisation
Research organisation
Saukonpaadenranta 2
Helsinki
00180
Finland
| Website | http://www.oncos.com |
|---|---|
"ROR" |
https://ror.org/00b8bzq64 |
Funders
Funder type
Research organisation
Oncos Therapeutics (Finland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/02/2022 | 26/10/2022 | Yes | No |
Editorial Notes
26/10/2022: Publication reference added.
