AzTrials
AzTrials

Metastatic MelanomaPhase 2METILDANCT01995344

TIL Therapy in Metastatic Melanoma and IL2 Dose Assessment

A Phase 2 study testing Cyclophosphamide, Fludarabine and Tumour Infiltrating Lymphocytes in people with Metastatic Melanoma, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.

Terminated

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

Official record
Search all trials

Trial summary

This is a two arm, open-labelled phase II randomised trial of Tumour Infiltrating Lymphocytes (TIL) in metastatic melanoma patients given with preconditioning chemotherapy and Interleukin-2 (IL2). Eligible patients will undergo surgical tumour excision from which TIL will be derived, cultured and expanded. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
Cyclophosphamide, Fludarabine and Tumour Infiltrating Lymphocytes
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
1 Mar 2014to 24 Jul 2015
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 malignant melanoma with confirmed evidence of progressive metastatic disease and to have failed / refused standard therapies.
  • They must have resectable metastatic lesion(s) of at least 2cm in diameter.
  • There must be measurable / evaluable disease after the surgical resection.
  • Patients may have had any previous systemic therapies including anti-CTLA4 (Ipilimumab) agent provided they are otherwise fit for treatment.
  • Tumour samples may be taken prior to other systemic therapy if patients wish to store the sample for possible future use.
  • Age equal to or greater than 18 years.
Show all 20Show fewer
  • World Health Organisation (WHO) performance status of 0 or 1.
  • Life expectancy >3months.
  • LVEF > 50% as measured by ECHO/MUGA and satisfactory stress ECHO (if over 60 or had previous cardiotoxic therapy).
  • Haemoglobin (Hb) ≥ 9.0 g/dL
  • Neutrophils ≥ 1.0 x 109/L
  • Platelets (Plts) ≥ 100 x 109/L
  • serum bilirubin ≤ 1.5 x ULN
  • alanine aminotransferase (ALT) ≤ 5 x ULN
  • aspartate aminotransferase (AST) ≤ 5 x ULN
  • alkaline phosphatase (ALP) ≤ 5 x ULN
  • Serum creatinine ≤ 0.15 mmol/L
  • 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 TIL treatment and for six months afterwards.
  • Full written informed consent

Who cannot join

  • Those receiving radiotherapy, targeted 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.
  • Previous radiotherapy treatment to the resectable metastatic site(s) within 1 year and no other suitable metastatic sites.
  • Participation in any other clinical trial within the previous 30 days or during the course of this treatment.
  • Previous allogeneic transplant.
  • Patient with ocular melanoma.
Show all 17Show fewer
  • Clinically significant cardiac disease. Examples would include unstable coronary artery disease, myocardial infarction within 6 months or Class III or IV AHA criteria for heart disease (see Appendix 6)
  • Patients who are high medical risks because of non-malignant systemic disease, including those with, 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 this therapy.
  • Concurrent systemic infections (CTCAE Grade 3 or more) within the 28 days prior to treatment.
  • Prior history of 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 HTLV.
  • History of systemic autoimmune disease which could be life-threatening if reactivation occurred (for example hypothyroidism would be permissible, prior rheumatoid arthritis or SLE would not).
  • Patients with more than 3 brain metastases.
  • Patients with symptomatic brain metastasis measuring more than 10mm in diameter or evidence of significant surrounding oedema on MRI will not be eligible until after treatment demonstrating no clinical or radiologic CNS progression for at least 2 months. Patient must be able to wean off any steroid use 3 weeks before treatment commencement.
  • Patients who are likely to require long-term 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, Greater Manchester, M20 4BX

Other trials in United Kingdom

About this study

Official title: A Randomised Phase II Study in Metastatic Melanoma to Evaluate the Efficacy of Adoptive Cellular Therapy With Tumour Infiltrating Lymphocytes (TIL) and Assessment of High Versus Low Dose Interleukin-2

This is a two arm, open-labelled phase II randomised trial of Tumour Infiltrating Lymphocytes (TIL) in metastatic melanoma patients given with preconditioning chemotherapy and Interleukin-2 (IL2). Eligible patients will undergo surgical tumour excision from which TIL will be derived, cultured and expanded. Patients will receive preconditioning chemotherapy with cyclophosphamide (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5 to day -1. The autologous TILs will be re-infused on day 0 and the patients will receive up to 12 doses of intravenous High Dose Interleukin-2 (HD-IL2) or Low Dose Interleukin-2 (LD-IL2) depending on the randomised arm.

The primary objectives are response rate assessed and compared by CT scans carried out at week 6, week 12 and at 12 weekly intervals thereafter and the evaluation of feasibility and tolerability of TIL therapy with HD-IL2 versus LD-IL2.

Being tested
Cyclophosphamide, Fludarabine, Tumour Infiltrating Lymphocytes, Interleukin-2
Medical subject headings
Melanoma

What participants receive

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

Study groups in NCT01995344
Study groupRoleWhat they receive
ARM A: High Dose Interleukin-2 (HD IL2)Active comparatorEligible participants will undergo surgical tumour excision from which TIL will be derived, cultured and expanded. Participants will receive preconditioning chemotherapy with cyclophosphamide (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5 to day -1. The autologous TILs will be re-infused on day 0 and the patients will receive up to 12 doses of intravenous HD IL2
Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Genetic: Tumour Infiltrating Lymphocytes; Drug: Interleukin-2
ARM B: Low Dose Interleukin-2 (LD IL2)Active comparatorEligible participants will undergo surgical tumour excision from which TIL will be derived, cultured and expanded. Participants will receive preconditioning chemotherapy with cyclophosphamide (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5 to day -1. The autologous TILs will be re-infused on day 0 and the patients will receive up to 12 doses of intravenous LD-IL2
Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Genetic: Tumour Infiltrating Lymphocytes; Drug: Interleukin-2

What is being measured

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

  1. Disease response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria

    Subject will have CT scan at 6,12,24 weeks post treatment to compare with baseline CT scan in order to assess disease response to therapy

    Measured: Best response

Timeline

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

  1. First posted26 Nov 2013 (estimated)
  2. Study start1 Mar 2014
  3. Primary completion24 Jul 2015
  4. Study completion24 Jul 2015

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01995344
Sponsor's protocol ID
11_DOG14_12
Other IDs
2013-001071-20
Acronym
METILDA
Status last verified
Apr 2023
First submitted
21 Nov 2013
Last updated
20 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide, Fludarabine and Tumour Infiltrating Lymphocytes in people with Metastatic Melanoma, run by The Christie NHS Foundation Trust 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 20 inclusion and 17 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 20 Apr 2023. 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?

Disease response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (time frame: Best response). 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 NCT01995344.

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 20 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in