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Cytokine

TILs + Interleukin-2 + Cyclophosphamide for High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase 1
Waitlist Available
Led By Marcus Butler, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of the study up to 11 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is for patients with ovarian cancer who haven't responded to platinum-based chemotherapy. They'll first receive cyclophosphamide, then an infusion of autologous tumor-infiltrating lymphocytes (TILs). TILs are a type of white blood cell 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.

Who is the study for?
This trial is for adults over 18 with platinum-resistant high grade serous ovarian, fallopian tube, or primary peritoneal cancer. Candidates must have a life expectancy of more than 3 months and be able to produce suitable TILs. They should not have HIV, active hepatitis B/C, syphilis, HTLV, or brain metastases unless treated. Women must use effective birth control.
What is being tested?
The study tests the effectiveness of re-stimulated tumor-infiltrating lymphocytes (TILs) combined with interleukin-2 (IL-2), cyclophosphamide and other agents in patients who haven't responded well to platinum-based chemotherapy. It's an early-phase trial to see how safe and effective this combination therapy is.
What are the potential side effects?
Potential side effects may include reactions from the immune system such as inflammation in various organs due to TILs and IL-2 therapy; nausea and hair loss from cyclophosphamide; fatigue; increased risk of infections; blood disorders; allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of the study up to 11 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of the study up to 11 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of occurrences and severity of side effects
Secondary study objectives
Clinical response to treatment
Number of patients with an immunity and no immunity to the study treatment

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401
88%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Fatigue
38%
Decreased appetite
35%
Confusional state
31%
Tachycardia
31%
Diarrhoea
31%
Hypokalaemia
27%
Constipation
27%
Hypophosphataemia
27%
Back pain
23%
Dizziness
23%
Tremor
23%
B-cell lymphoma
23%
Platelet count decreased
23%
White blood cell count decreased
19%
Cough
19%
Agitation
19%
Hyponatraemia
19%
Neutropenia
19%
Tachypnoea
19%
Hypogammaglobulinaemia
19%
Oedema peripheral
15%
Hypomagnesaemia
15%
Thrombocytopenia
15%
Dysphagia
15%
Alanine aminotransferase increased
15%
Sinus tachycardia
15%
Chills
15%
Dyspnoea
12%
Aspartate aminotransferase increased
12%
Pain
12%
Arthralgia
12%
Myalgia
12%
Hypertension
12%
Hyperglycaemia
12%
Hypoxia
12%
Vomiting
12%
Abdominal pain
12%
Peripheral sensory neuropathy
12%
Covid-19
12%
Malaise
8%
Dysuria
8%
Muscular weakness
8%
Blood creatinine increased
8%
Hyperhidrosis
8%
Insomnia
8%
Acute myeloid leukaemia
8%
Encephalopathy
8%
Sepsis
8%
Pancytopenia
8%
Eye pain
8%
Lymphocyte count decreased
8%
Asthenia
8%
Urinary tract infection
8%
Somnolence
8%
Oral candidiasis
8%
Pneumonia
8%
Gait disturbance
8%
Aphasia
4%
Pleural effusion
4%
Depression
4%
Embolism
4%
Syncope
4%
Respiratory failure
4%
Febrile neutropenia
4%
Covid-19 pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Re-Stimulated Tumor-Infiltrating Lymphocytes and interleukin-2Experimental Treatment3 Interventions
Cyclophosphamide will be given prior to Re-Stimulated Tumor-Infiltrating Lymphocytes, and interleukin-2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interleukin-2
1994
Completed Phase 3
~690
Cyclophosphamide
2010
Completed Phase 4
~2310

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
503,195 Total Patients Enrolled
15 Trials studying Ovarian Cancer
3,033 Patients Enrolled for Ovarian Cancer
Marcus Butler, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
3 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Interleukin-2 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT01883297 — Phase 1
Ovarian Cancer Research Study Groups: Re-Stimulated Tumor-Infiltrating Lymphocytes and interleukin-2
Ovarian Cancer Clinical Trial 2023: Interleukin-2 Highlights & Side Effects. Trial Name: NCT01883297 — Phase 1
Interleukin-2 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01883297 — Phase 1
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