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Oesophageal CancerPhase 2ATTACK-OGNCT01795976

NY-ESO-1 T Cells in OG Cancer

A Phase 2 study testing NY-ESO-1 T cells, cyclophosphamide and Fludarabine in people with Oesophageal Cancer, run by Fiona Thistlethwaite at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a trial of adoptive T cell therapy using the patient's own T cells, genetically engineered to target the tumour associated antigen NY-ESO-1 (New York esophageal squamous cell carcinoma 1). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oesophageal Cancer
What is being tested?
NY-ESO-1 T cells, cyclophosphamide and Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2014to Nov 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed oesophagogastric cancer with confirmed evidence of metastatic disease and to have failed or refused standard therapies.
  • There must be measurable disease
  • Patients may have had any previous systemic therapies provided they are otherwise fit for treatment
  • Age equal to or greater than 18 years
  • World Health Organisation (WHO) performance status of 0 or 1
  • Patients must be HLA-A2 positive
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  • Their tumour must stain positive by immunohistochemistry for NY-ESO-1 (either diagnostic or more recent biopsy is acceptable)
  • Life expectancy >3months
  • Left ventricular ejection fraction (LVEF) > 50% as measured by ECHO or Multi Gated Acquisition Scan (MUGA)
  • Haematological and biochemical indices:
  • Haemoglobin (Hb) ≥ 8.0 g/dL
  • Neutrophils ≥ 1.0 x 10*9/L
  • Platelets (Plts) ≥ 100 x 10*9/L
  • Any of the following abnormal baseline liver function tests:
  • serum bilirubin ≤ 20 mmol/l (ULN)
  • alanine aminotransferase (ALT) and/or
  • aspartate aminotransferase (AST) and/or
  • ≤ 3 x ULN unless patient has liver metastases when can be < 5 x ULN.
  • Serum creatinine ≤ 0.15 mmol/L or creatinine clearance > 50 ml/min
  • These measurements must be performed prior to leukaphereses and again prior to commencing preconditioning chemotherapy.
  • The chemotherapy to be used in this trial is non-myeloablative, but where patients have had previous high dose chemotherapy, an autologous haemopoietic stem cell backup harvest, for stem cell rescue, will be obtained prior to commencing therapy in this trial. Similarly, where there is concern about a patient's bone marrow reserves, for example due to multiple previous lines of myelosuppressive chemotherapy a backup stem cell harvest should also be obtained.
  • Female patients of child-bearing potential must have a negative serum or urine pregnancy test prior treatment and agree to use appropriate medically approved contraceptive precautions for four weeks prior to entering the trial, during the trial, and for six months afterwards.
  • Male patients must agree to use barrier method contraception during the treatment and for six months afterwards.
  • Able to provide full written informed consent.

Who cannot join

  • Those receiving radiotherapy, biological therapy, endocrine therapy, immunotherapy, systemic steroids, or chemotherapy during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment.
  • All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities, which an investigator considers should not exclude the patient.
  • Participation in any other clinical trial within the previous 30 days or during the course of this treatment.
  • Previous allogeneic transplant.
  • Clinically significant cardiac disease.
  • Patients who are high medical risks because of non-malignant systemic disease, including those with active infection, uncontrolled cardiac or respiratory disease, or other serious medical or psychiatric disorders which in the lead clinicians opinion would not make the patient a good candidate for adoptive T-cell therapy.
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  • Concurrent serious infections within the 28 days prior to treatment
  • Current malignancies at other 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.
  • Patients known or found to be serologically positive for Hepatitis B, C, HIV or Human T cell lymphotropic Virus (HTLV).
  • History of systemic autoimmune disease which could be life-threatening if reactivation occurred( for example hypothyroidism would be permissible, prior rheumatoid arthritis or systemic lupus erythematosus (SLE0 would not).
  • Evidence of Centra Nervous System (CNS) involvement.
  • Patients who are likely to require systemic steroids or other immunosuppressive therapy.
  • Pregnant and lactating women.
  • Radiotherapy to >25% skeleton.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The Christie NHS Foundation Trust

    Manchester, M20 3EE

Other trials in United Kingdom

About this study

Official title: A Phase II Trial to Assess the Activity of NY-ESO-1 Targeted T Cells in Advanced Oesophagogastric Cancer

This is a trial of adoptive T cell therapy using the patient's own T cells, genetically engineered to target the tumour associated antigen NY-ESO-1 (New York esophageal squamous cell carcinoma 1). Eligible patients will undergo leukapheresis (a process to remove white blood cells) to retrieve sufficient T cells which will be gene modified and expanded in the laboratory. Patients will undergo preconditioning chemotherapy with cyclophosphamide (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5 to day -1. The NY-ESO-1 gene modified cells will be re-infused on day 0 and the patients will receive up to 14 doses of intravenous Interleukin2 (100000 U/kg) from day 0 to day 4.

The primary objective of response rate according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria will be assessed by CT scans carried out at week 6, week 12 and at 12 weekly intervals thereafter.

Being tested
NY-ESO-1 T cells, cyclophosphamide, Fludarabine, Interleukin 2
Keywords
Oesophageal cancer
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NY-ESO-1 T cellsGenetic

  • cyclophosphamideDrug

    cyclophosphamide 60mg/kg/day day -7 and day -6

  • FludarabineDrug

    Fludarabine given 25mg/m2 day -5 to day -1

  • Interleukin 2Biological

    Also called IL2

    Interleukin 2 (IL2) immunotherapy given day 0 to day 6

Study groups in NCT01795976
Study groupRoleWhat they receive
NY-ESO-1 T cellsExperimentalNY-ESO-1 T cells are T cells engineered to target the tumour antigen NY-ESO-1. Autologous T cells are obtained from eligible patients who have NY-ESO-1 positive tumours and who are Human Leukocyte Antigen serotype "A" serotype group (HLA2) positive. The T cells undergo lentiviral transduction with NY-ESO-1 specific nucleic acid under Good Manufacturing Practice (GMP) conditions. The patient will then undergo preconditioning chemotherapy with a regime of cyclophosphamide 60mg/kg/day day -7 and -6 followed by fludarabine 25mg/m2 day -5 to -1. They will receive autologous NY-ESO-1 T cells on day 0 and following on from that they will receive up to 14 doses of intravenous IL-2 at a dose of 100000 units per kg..
Receives: Genetic: NY-ESO-1 T cells; Drug: cyclophosphamide; Drug: Fludarabine; Biological: Interleukin 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate to New York esophageal squamous cell carcinoma (NYESO) T cells

    To evaluate the response rate in Oesophagogastric cancer patients who are New York esophageal squamous cell carcinoma 1 (NY-ESO-1)and Human Leukocyte Antigen serotype "A" serotype group (HLA-A2) positive to adoptive cell therapy targeted to NY-ESO-1.

    Measured: 6 weeks post treatment

  2. Response rate to NYESO T cells

    To evaluate the response rate in Oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive to adoptive cell therapy targeted to NY-ESO-1.

    Measured: 12 weeks post treatment

  3. Response rate to NYESO T cells

    To evaluate the response rate in Oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive to adoptive cell therapy targeted to NY-ESO-1.

    Measured: 24 weeks post treatment

  4. Response rate to NYESO T cells

    To evaluate the response rate in Oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive to adoptive cell therapy targeted to NY-ESO-1.

    Measured: 36 weeks post treatment

  5. Response rate to NYESO T cells

    To evaluate the response rate in Oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive to adoptive cell therapy targeted to NY-ESO-1.

    Measured: 48 weeks post treatment

Secondary outcomes (3)

  1. Feasibility and tolerability of NY-ESO-1 targeted cell therapy

    Evaluation of feasibility and tolerability of adoptive cell therapy targeted to NY-ESO-1 in Oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive.

    Measured: Feasibility will be assessed proceed to full therapy (Study day 6).

  2. Evaluation of the progression free survival

    measuring length of time from point of cell infusion until disease progression.

    Measured: Until progression occurs, estimated to be average of 12 months per patient.

  3. Feasibility and tolerability of NY-ESO-1 targeted cell therapy

    Evaluation of feasibility and tolerability of adoptive cell therapy targeted to NY-ESO-1 in Oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive.

    Measured: Tolerability will be assessed for follow-up period, estimated to be average of 12 months per patient.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2013 (estimated)
  2. Study startOct 2014
  3. Primary completionNov 2017
  4. Study completionNov 2017

Why it stopped: Withdrawal of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01795976
Sponsor's protocol ID
12_DOG14_22
Acronym
ATTACK-OG
Status last verified
Aug 2018
First submitted
10 Jan 2013
Last updated
7 Aug 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NY-ESO-1 T cells, cyclophosphamide and Fludarabine in people with Oesophageal Cancer, run by Fiona Thistlethwaite at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Withdrawal of funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate to New York esophageal squamous cell carcinoma (NYESO) T cells (time frame: 6 weeks post treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01795976.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.

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