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AzTrials

Metastatic Ovarian CancerPhase 1NCT02482090

TIL Therapy for Metastatic Ovarian Cancer

A Phase 1 study testing Cyclophosphamide, Fludarabine and TIL infusion in people with Metastatic Ovarian Cancer, run by Inge Marie Svane at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Metastatic Ovarian Cancer
What is being tested?
Cyclophosphamide, Fludarabine and TIL infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteDenmark
Study dates
Jul 2015to Apr 2017
Phase
Phase 1
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed high grade serous adenokarcinoma ovarian cancer metastasis available for surgical resection (more than 1 cm3) and residual measurable disease after resection
  • Progression/reccurence of ovarian cancer after 1. line platin based chemotherapy or progression/reccurence after 2. line or additional chemotherapy
  • ECOG performance status 0-1
  • Life expectancy > 6 months
  • No significant toxicity from prior treatments, except sensoric- and motoric neuropathia and/or alopecia
  • Adequate renal, hepatic and hematological function
  • Women of childbearing potentil (WOCBP) must be using an effective method of contraception during treatment and for at least 6 months after completion of treatment
  • Able to comprehend the information given and willing to sign informed consent

Who cannot join

  • Other malignancies, unless followed for ≥ 5 years with no sign of disease
  • Severe allergies, history of anaphylaxis or known allergies to the administered drugs.
  • Serious medical or psychiatric comorbidity
  • Creatinine clearance < 70 ml/min
  • Acute or chronic infection with e.g. HIV, hepatitis, tuberculosis
  • Severe and active autoimmune disease
Show all 11Show fewer
  • Pregnant and nursing women
  • Need for immunosuppressive treatment, e.g. corticosteroids or methotrexate
  • Concomitant treatment with other experimental drugs
  • Patients with uncontrolled hypercalcemia
  • Less than four weeks since prior systemic antineoplastic treatment at the time of treatment

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Center for Cancer Immune Therapy Dept. of Hematology/oncology

    Copenhagen, Herlev, 2730

Other trials in Denmark

About this study

Official title: T Cell Therapy for Patients With Metastatic Ovarian Cancer

Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion Interleukin-2 is administered to support T cell acitivation and proliferation in vivo.

Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma, including Ovarian Cancer. In this study TIL therapy is administered to patients with metastatic Ovarian Cancer.

Read the detailed description

Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion Interleukin-2 is administered to support T cell acitivation and proliferation in vivo.

Objectives:

To evaluate safety and feasibility when treating patients with metastatic ovarian cancer with ACT with TILs.

To evaluate treatment related immune responses To evaluate clinical efficacy

Design:

Patients will be screened with a physical exam, medical history, blood samples and ECG.

Patients will undergo surgery to harvest tumor material for TIL production. Patients is admitted day -8 in order to undergo lymphodepleting chemotherapy with cyclophosphamide and fludara starting day -7.

On day 0 patients receive TIL infusion and shortly after starts IL-2 infusion continually following the decrescendo regimen.

The patients will followed until progression or up to 5 years

Being tested
Cyclophosphamide, Fludarabine, TIL infusion, Interleukin-2
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • CyclophosphamideDrug

    Also called Cyclophospamide

    Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.

  • FludarabineDrug

    Also called Fludarabinephosphate, Fludara

    Fludarabine 25 mg/m2 is administered on day -5 to day -1.

  • TIL infusionBiological

    Also called T Cell infusion

    The maximum number of expanded TILs are infused over 30-45 minutes on day 0.

  • Interleukin-2Drug

    Also called IL-2, Proleukin

    Interleukin-2 is administered as a continous i.v. infusion in a decrescendo regimen (18 MIU/m3 IL-2 over 6 hours, 18 MIU/m2 IL-2 over 12 hours, 18 MIU/m2 IL-2 over 24 hours followed by 4,5 MIU/m2 IL-2 over another 24 hours for three days).

Study groups in NCT02482090
Study groupRoleWhat they receive
Patient groupExperimentalAll patients receive the same treatment. Alle patients are hospitalized during treatment (approximately 3 weeks) and receive treatment only once. Stem Cells are harvested a minimum of 3 weeks before treatment for potential later use if the patients are having difficulties recovering from the lymphodepleting chemotherapy. The patients are admitted to hospital day -8 and receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine= on day -7 to day -1. The TILs are infused on day 0 and Interleukin-2 therapy is administered on day 0 to day 5. Interleukin-2 is administered in an i.v. continous decrescendo regimen starting approximately 6 hours after TIL infusion with a duration of approximately 5 days. Stem Cells can be administered after treatment if needed.
Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: TIL infusion; Drug: Interleukin-2

What is being measured

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

  1. Number and type of reported adverse events

    Determine the safety of the administration of TIL therapy including lymphodepleting chemotherapy and Interleukin-2 for patients with metastatic Ovarian Cancer by reporting adverse events according to CTCAE v. 4.0.

    Measured: 0-24 weeks

Secondary outcomes (4)

  1. Treatment related immune responses

    To evaluate the immunological impact of TIL therapy for patients with metastatic Ovarian Cancer

    Measured: Up to 12 months

  2. Objective response rate

    Clinical responses will be evaluated by RECIST 1.1.

    Measured: Up to 12 months

  3. Overall Survival

    Overall Survival (OS), defined as time from treatment initiation to death, will be described with use of Kaplan Meier curve.

    Measured: Up to 12 months

  4. Progression free survival

    Progression free survival (PFS), defined as the time from treatment initiation to disease progression, relapse or death due to any cause, which ever comes first, will be described with Kaplan Meier curve.

    Measured: Up to 12 months

Timeline

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

  1. First posted25 Jun 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionDec 2016
  4. Study completionApr 2017

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02482090
Sponsor's protocol ID
GY1508
Status last verified
Aug 2017
First submitted
23 Jun 2015
Last updated
16 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Westergaard MCW, Andersen R, Chong C, Kjeldsen JW, Pedersen M, Friese C, Hasselager T, Lajer H, Coukos G, Bassani-Sternberg M, Donia M, Svane IM. Tumour-reactive T cell subsets in the microenvironment of ovarian cancer. Br J Cancer. 2019 Feb;120(4):424-434. doi: 10.1038/s41416-019-0384-y. Epub 2019 Feb 5.

    PubMed 30718808

  • Andersen R, Donia M, Westergaard MC, Pedersen M, Hansen M, Svane IM. Tumor infiltrating lymphocyte therapy for ovarian cancer and renal cell carcinoma. Hum Vaccin Immunother. 2015;11(12):2790-5. doi: 10.1080/21645515.2015.1075106.

    PubMed 26308285

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cyclophosphamide, Fludarabine and TIL infusion in people with Metastatic Ovarian Cancer, run by Inge Marie Svane at 1 site in Denmark.

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 8 inclusion and 11 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: finished, as of the sponsor's last update on 16 Aug 2017. 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 Denmark. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number and type of reported adverse events (time frame: 0-24 weeks). 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 NCT02482090, which also lists 2 linked publications.

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 16 Aug 2017.

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