RecurrentPhase 1NCT01883297

"Re-Stimulated" TILs And IL-2 Therapy for Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase 1 study testing Re-stimulated tumor-infiltrating lymphocytes (TILs), Interleukin-2 and Cyclophosphamide in people with Recurrent and Platinum-resistant, run by University Health Network, Toronto at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This is a phase I clinical study for patients with platinum-resistant high grade serous ovarian, fallopian tube, or primary peritoneal cancer, and the response to a combination of cyclophosphamide, autologous tumor-infiltrating lymphocytes (TILs), autologous dendritic cells (DCs), and OKT3 (anti-CD3 antibody), along… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent, Platinum-resistant, High Grade Serous Ovarian Cancer
What is being tested?: Re-stimulated tumor-infiltrating lymphocytes (TILs), Interleukin-2 and Cyclophosphamide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteCanada
Study dates: Jan 2015to Jun 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

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

Platinum resistant high grade serous ovarian, fallopian tube, or primary peritoneal cancer.
Tumor is suitable for harvest (i.e., lesion to be harvested for TIL evaluation has a total volume of ≥1cm3) or patient has previously undergone tumor harvest under other REB approved studies involving clinical evaluation of TILs.
If tumor harvest is required, subject must be a suitable surgical candidate in the opinion of the operating surgeon.
Patient age: ≥ 18 years.
Clinical performance status of ECOG 0 or 1.
Life expectancy > 5 months from the date of consent for TIL evaluation.

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Ability to understand and has signed the Pre-Screening Consent Form.
Patients are willing to be tested for transmissible diseases (active Hepatitis B (HBV) or Hepatitis C (HCV), human immunodeficiency virus (HIV), Human T-Cell Lymphotropic Virus (HTLV), Herpes Simplex Virus (HSV), Cytomegalovirus (CMV), Syphilis (with West Nile Virus only tested between May 1st and November 30th)
Confirmation that the Translational Immunotherapy Lab is able to process the specimen
If there is a history of allergy to penicillin, gentamycin, streptomycin, or anti-fungals, the ability to generate TILs should first be confirmed with the cell manufacturing lab (i.e., Translational Immunotherapy Laboratory).
Prior to the performance of any study-specific procedure, the subject has signed and dated the informed consent form, approved by a Research Ethics Board (REB), after the nature of the study has been explained and the subject has had the opportunity to ask questions.
Recurrent platinum resistant high grade serous ovarian, fallopian tube, or primary peritoneal cancer, with evidence of disease progression from previous line of treatment.
Measurable disease by RECIST 1.1.
Subjects should have no brain metastases. Note if brain metastases are present, these lesions must undergo definitive treatment with surgery and/or radiation at least 30 days prior to the first dose of lymphodepleting chemotherapy. If in the opinion of the PI or his designee the lesion(s) no longer represents active disease, the subject will be considered eligible.
Clinical performance status of ECOG 0 or 1.
Life expectancy > 3 months from the date of consent for TIL treatment.
Laboratory analyses of tumor-infiltrating lymphocytes (TILs) from the subject must demonstrate that the TILs are suitable for use in protocol treatment (performed by the Translational Immunotherapy Laboratory, Princess Margaret Cancer Centre)
More than 30 days has elapsed since any prior systemic therapy at the time of the cell infusion. All subjects' toxicities must have recovered to a CTCAE grade 1 or less; however, patients with residual CTCAE grade 2 neuropathy from previous carboplatin/taxol treatment will not be excluded. Subjects may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to CTCAE grade 1 or less or as specified in the inclusion criteria listed above.
Adequate organ function as defined by the following criteria:
Serum ALT ≤ 2.5 x upper limit of normal (ULN) (for patients with liver metastases, serum ALT ≤ 3 x ULN;
Serum AST ≤ 2.5 x upper limit of normal (ULN) (for patients with liver metastases, serum AST ≤ 3 x ULN;
Total serum bilirubin ≤ 2xULN (patients with Gilbert's Syndrome - direct serum bilirubin ≤ 2 x ULN);
Absolute neutrophil count (ANC) ≥ 1.5x109/L;
Platelets ≥100x109/L;
Hemoglobin ≥ 90 g/L for female;
Alkaline phosphatase ≤ 2 x ULN;
Serum creatinine within normal institutional limits OR serum creatinine clearance ≥ 60 mL/min/1.73m2 for patients with creatinine levels above institutional normal;
Serum lipase≤ 1.5 x ULN;
Serum amylase ≤ 1.5 x ULN
Women of child-bearing potential must have a negative pregnancy test. Acceptable birth control failure rate of less than or equal to 1% when used consistently and correctly such as implants, injectables, combined oral contraceptives, double barrier, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner. Subjects are considered to be not of child bearing potential if they are considered to be post-menopausal or surgically sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy. Women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, ovarian suppression or any other reversible reason.

Who cannot join

Subjects with ongoing or prior use systemic steroid therapy within 4 weeks before the TILs infusion will be excluded. Use of topical, intranasal and inhaled corticosteroids, or systemic corticosteroids at physiologic doses are allowed. Oral steroid use as premedication to prevent allergic reactions to radiologic contrast is allowed.
Subjects cannot be HIV positive.
Subjects cannot have active hepatitis B or hepatitis C, syphilis, or Human T-Cell Lymphotropic Virus (HTLV).
The number of prior lines of chemotherapy is not limited. However, if the subject has had ≥3 lines of prior chemotherapy for platinum refractory or platinum resistant disease, documentation of a response to one of these lines is required. Response can be defined by RECIST 1.1 or CA125 as defined by the modified GCIG criteria (See Section 11).
The subject cannot have any active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, uncontrolled psychiatric disorders, or other conditions that may affect compliance with the trial.
The subject must have no active underlying cardiac illnesses defined by positive stress test, LVEF<40% or ongoing life-threatening arrhythmias (i.e., for patients older than 60 years of age or otherwise clinically indicated).
Subjects who have a prolonged history of cigarette smoking or symptoms of respiratory dysfunction will be excluded if they have an abnormal pulmonary function test as evidenced by a FEV1 < 60% predicted.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Phase I Study Evaluating the Feasibility and Safety of Infusion of "Re-Stimulated" Autologous TILs Followed by Low-Dose IL-2 Therapy in Patients With Platinum Resistant High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Read the detailed description

This is a phase I clinical study for patients with platinum-resistant (does not respond to platinum-based chemotherapy) high grade serous ovarian, fallopian tube, or primary peritoneal cancer. Prior to the main treatment, patients will receive cyclophosphamide by vein. Patients will then receive an infusion (given by vein) of autologous tumor-infiltrating lymphocytes (TILs) which will first be taken from the patient, then be stimulated with certain substances called autologous dendritic cells (DCs) and OKT3 (anti-CD3 antibody), and then given back to the patient as an infusion. This is believed to make the TILs work better. TILs are a type of white blood cells that recognizes tumor cells and enter them which causes the tumor cells to break down. After infusion of TILs, low-dose interleukin-2 (IL-2) therapy will be given.

Conditions: Recurrent, Platinum-resistant, High Grade Serous Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Being tested: Re-stimulated tumor-infiltrating lymphocytes (TILs), Interleukin-2, Cyclophosphamide
Keywords: Measurable, Recurrent, Platinum resistant, Tumor-Infiltrating Lymphocytes, Low-Dose Interleukin-2, Autologous dendritic cells, Anti-CD3 monoclonal antibody, High grade serous ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer, Cyclophosphamide
Medical subject headings: Recurrence, Fallopian Tube Neoplasms

What participants receive

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

Re-stimulated tumor-infiltrating lymphocytes (TILs)Biological
Intravenous infusions: Dose level 1 (3 patients): 3x10^7 TILs (with maximum 3x10^6 autologous dendritic cells); Dose level 2 (3 patients): 1x10^8 TILs (with maximum 1x10^7 autologous dendritic cells); Dose level 3 (3 patients): 3x10^8 TILs (with maximum 3x10^8 autologous dendritic cells)
Interleukin-2Biological
Also called Aldesleukin, Proleukin, Recombinant Human Interleukin 2
Subcutaneous injections of IL-2 x 4 days during the first week and x 5 days the second week with 2 days of rest in between each week of dosing
CyclophosphamideDrug
Also called Procytox
Intravenous infusion: 30 mg/kg/day for 2 days (Day -3 and -2 prior to infusion of TILs)

Study groups in NCT01883297
Study group	Role	What they receive
Re-Stimulated Tumor-Infiltrating Lymphocytes and interleukin-2	Experimental	Cyclophosphamide will be given prior to Re-Stimulated Tumor-Infiltrating Lymphocytes, and interleukin-2. Receives: Biological: Re-stimulated tumor-infiltrating lymphocytes (TILs); Biological: Interleukin-2; Drug: Cyclophosphamide

What is being measured

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

Number of occurrences and severity of side effects
Toxicities will be monitored on an ongoing basis by the investigators. Toxic effects will be categorized using the CTCAE v4.0 and will be reported using summary statistics. The highest toxicity for each patient in each category or subcategory will be described. Both events related and unrelated to treatment will be captured. The total number of episodes for each event reported, the severity and attribution to study therapy of each episode reported will also be displayed.
Measured: Starting at first dose of study treatment up to 10 years

Secondary outcomes (2)

Clinical response to treatment
Evaluation of the clinical response (clinical tumor regression), which will be monitored and reported according to RECIST v1.1 criteria and Immune-Related Response Criteria.
Measured: 6 weeks after treatment
Number of patients with an immunity and no immunity to the study treatment
Immunological assessments of peripheral blood mononuclear cells, serum and tissue biopsies (if any) will be reported using units appropriate to each particular assay. Results from immunohistochemical evaluations of tissue biopsies will be reported descriptively. Descriptive statistics will be used to summarize immunological findings. Any correlation with clinical response rate will be reported descriptively.
Measured: From start of the study up to 11 years

Timeline

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

Jan 2015Jun 2027

First posted21 Jun 2013 (estimated)
Study startJan 2015
Primary completionJun 2027 (estimated)
Study completionJun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for RecurrentStudies of the same condition, open and under way.
More trials run by University Health Network, TorontoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01883297
Sponsor's protocol ID: TILs-001-DC
Status last verified: Jul 2026
First submitted: 11 Jun 2013
Last updated: 7 Jul 2026
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Study Evaluating the Feasibility and Safety of Infusion of "Re-Stimulated" Autologous TILs Followed by Low-Dose IL-2 Therapy in Patients With Platinum Resistant High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
ClinicalTrials.gov ID: NCT01883297
Acronym / sponsor ID: TILs-001-DC
Conditions: Recurrent, Platinum-resistant, High Grade Serous Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Keywords: Measurable, Recurrent, Platinum resistant, Tumor-Infiltrating Lymphocytes, Low-Dose Interleukin-2, Autologous dendritic cells, Anti-CD3 monoclonal antibody, High grade serous ovarian cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 3 participants (actual)
Lead sponsor: University Health Network, TorontoUniversity, hospital or other
Study start: Jan 2015
Primary completion: Jun 2027 (estimated)
Study completion: Jun 2027 (estimated)
First posted: 21 Jun 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Re-Stimulated Tumor-Infiltrating Lymphocytes and interleukin-2	Experimental	Biological: Re-stimulated tumor-infiltrating lymphocytes (TILs), Biological: Interleukin-2, Drug: CyclophosphamideCyclophosphamide will be given prior to Re-Stimulated Tumor-Infiltrating Lymphocytes, and interleukin-2.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (30 listed)

Platinum resistant high grade serous ovarian, fallopian tube, or primary peritoneal cancer.
Tumor is suitable for harvest (i.e., lesion to be harvested for TIL evaluation has a total volume of ≥1cm3) or patient has previously undergone tumor harvest under other REB approved studies involving clinical evaluation of TILs.
If tumor harvest is required, subject must be a suitable surgical candidate in the opinion of the operating surgeon.
Patient age: ≥ 18 years.
Clinical performance status of ECOG 0 or 1.

Key exclusion criteria (7 listed)

Subjects with ongoing or prior use systemic steroid therapy within 4 weeks before the TILs infusion will be excluded. Use of topical, intranasal and inhaled corticosteroids, or systemic corticosteroids at physiologic doses are allowed. Oral steroid use as premedication to prevent allergic reactions to radiologic contrast is allowed.
Subjects cannot be HIV positive.
Subjects cannot have active hepatitis B or hepatitis C, syphilis, or Human T-Cell Lymphotropic Virus (HTLV).
The number of prior lines of chemotherapy is not limited. However, if the subject has had ≥3 lines of prior chemotherapy for platinum refractory or platinum resistant disease, documentation of a response to one of these lines is required. Response can be defined by RECIST 1.1 or CA125 as defined by the modified GCIG criteria (See Section 11).
The subject cannot have any active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, uncontrolled psychiatric disorders, or other conditions that may affect compliance with the trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Re-stimulated tumor-infiltrating lymphocytes (TILs)Intravenous infusions: Dose level 1 (3 patients): 3x10^7 TILs (with maximum 3x10^6 autologous dendritic cells); Dose level 2 (3 patients): 1x10^8 TILs (with maximum 1x10^7 autologous dendritic cells); Dose level 3 (3 patients): 3x10^8 TILs (with maximum 3x10^8 autologous dendritic cells)	Biological	Re-Stimulated Tumor-Infiltrating Lymphocytes and interleukin-2
Interleukin-2Also: Aldesleukin, Proleukin, Recombinant Human Interleukin 2Subcutaneous injections of IL-2 x 4 days during the first week and x 5 days the second week with 2 days of rest in between each week of dosing	Biological	Re-Stimulated Tumor-Infiltrating Lymphocytes and interleukin-2
CyclophosphamideAlso: ProcytoxIntravenous infusion: 30 mg/kg/day for 2 days (Day -3 and -2 prior to infusion of TILs)	Drug	Re-Stimulated Tumor-Infiltrating Lymphocytes and interleukin-2

Primary outcome

Number of occurrences and severity of side effects
Time frame: Starting at first dose of study treatment up to 10 years
Toxicities will be monitored on an ongoing basis by the investigators. Toxic effects will be categorized using the CTCAE v4.0 and will be reported using summary statistics. The highest toxicity for each patient in each category or subcategory will be described. Both events related and unrelated to treatment will be captured. The total number of episodes for each event reported, the severity and attribution to study therapy of each episode reported will also be displayed.

2 secondary outcomes

Clinical response to treatment
Time frame: 6 weeks after treatment
Number of patients with an immunity and no immunity to the study treatment
Time frame: From start of the study up to 11 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marcus Butler, M.D. principal investigator

Princess Margaret Cancer Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 30 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

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 of occurrences and severity of side effects (time frame: Starting at first dose of study treatment up to 10 years). 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 NCT01883297.

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 Jul 2026.