A Cancer Research UK phase I trial of adoptive transfer of autologous tumour antigen specific T-cells with pre-conditioning chemotherapy and intravenous interleukin-2 (IL2) in patients with advanced carcinoembryonic antigen (CEA) positive tumours
| ISRCTN | ISRCTN65902492 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65902492 |
| EudraCT/CTIS number | 2005-004085-16 |
| ClinicalTrials.gov number | NCT01212887 |
| Secondary identifying numbers | 6499 |
- Submission date
- 30/06/2010
- Registration date
- 30/06/2010
- Last edited
- 06/03/2018
- 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
Contact information
Ms Anvi Wadke
Scientific
Scientific
Department of Medical Oncology
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
| Phone | +44 161 446 8107 |
|---|---|
| anvi.wadke@christie.nhs.uk |
Study information
| Study design | Single centre non-randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A Cancer Research UK phase I trial of adoptive transfer of autologous tumour antigen specific T-cells with pre-conditioning chemotherapy and intravenous interleukin-2 (IL2) in patients with advanced carcinoembryonic antigen (CEA) positive tumours |
| Study acronym | MFEz Study |
| Study hypothesis | This trial proposes to use engineered T cells (MFEz T cells) comprising polyclonal CD4 and CD8 populations in place of the selected, specific TILs and combines these with 'supportive therapies' of pre-conditioning chemotherapy and high dose intravenous IL2. |
| Ethics approval(s) | MREC approved (ref: GTAC096) |
| Condition | Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: All |
| Intervention | Patients will receive pre-conditioning chemotherapy followed by MFEz T cells and then intravenous IL2. The pre-conditioning chemotherapy regime and the dose of MFEz T cells will be determined by the dose escalation scheme. Chemotherapy will only be commenced if adequate transduction and expansion of MFEz T cells has occurred. One cycle only of chemotherapy and MFEz T cells will be given. Further cycles of IL2 may be considered if specified criteria are met. Study entry: registration only |
| Intervention type | Other |
| Primary outcome measure | To evaluate the feasibility of using MFEz T cells |
| Secondary outcome measures | 1. To determine dose of MFEz T cells that gives the highest frequency in the circulation as measured 2. Adverse event assessment for as long as the patient is able to attend clinic according to CTCAE |
| Overall study start date | 29/11/2007 |
| Overall study end date | 17/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 22; UK sample size: 22 |
| Participant inclusion criteria | 1. Have histologically confirmed malignancy that is CEA positive that is metastatic or unresectable and for which standard curative or palliative measures: 1.1. Do not exist 1.2. Are no longer effective 1.3. Have been completed 1.4. Have been refused 2. Provide written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up 3. Be 18 years or over, either sex 4. Have a life expectancy of at least 3 months 5. Have a World Health Organization (WHO) performance status of 0 or 1 6. Female patients of child-bearing potential are eligible, provided they have a negative serum or urine pregnancy test prior to enrolment and agree to use appropriate medically approved contraceptive precautions for four weeks prior to leukapheresis, during the trial, and for six months afterwards 7. Male patients must agree to use barrier method contraception during the trial and for six months afterwards 8. Patients receiving cyclophosphamide must have a left ventricular ejection fraction (LVEF) of greater than or equal to 50% on multiple gated acquisition (MUGA) scan (within 4 weeks prior to leukapheresis) 9. Patients must have haematological and biochemical indices within the following ranges at screening. These measurements must be repeated to confirm eligibility between leukapheresis and commencing chemotherapy. |
| Participant exclusion criteria | 1. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosureas and Mitomycin-C) prior to treatment with chemotherapy in the trial or during the course of the trial. 2. Toxic manifestations of previous treatments. Exceptions to this are alopecia or certain grade 1 toxicities which in the opinion of the Investigator and CRUK should not exclude the patient (grade 1 neuropathy or grade 1 fatigue). 3. Primary brain tumours or brain metastases 4. Major thoracic and/or abdominal surgery from which the patient has not yet recovered 5. At high medical risk because of non-malignant systemic disease including active uncontrolled infection 6. Known to be serologically positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or human T cell lymphotropic virus (HTLV) 7. History of autoimmune disease 8. Inflammatory bowel disease 9. Concurrent congestive heart failure or prior history of class III - IV cardiac disease (New York Heart Association [NYHA]) 10. Prior bone marrow transplant or have had extensive radiotherapy to greater than 25% of bone marrow 11. Patients who are taking, or likely to require systemic steroids or other immunosuppressive therapy 12. Current malignancies originating from other primary sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin 13. Participation in any other clinical trial within the previous 30 days prior to leukapheresis or during the course of this trial 14. Concurrent serious infections within the 28 days prior to leukapheresis 15. Any other condition which in the Investigator's opinion would not make the patient a suitable candidate for the clinical trial |
| Recruitment start date | 29/11/2007 |
| Recruitment end date | 17/05/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Medical Oncology
Manchester
M20 4BX
United Kingdom
M20 4BX
United Kingdom
Sponsor information
Christie Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Wilmslow Road
Manchester
M20 4BX
England
United Kingdom
| Website | http://www.christie.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/03v9efr22 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2017 | Yes | No |
Editorial Notes
06/03/2018: Publication reference added.
