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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of the study up to 11 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of occurrences and severity of side effects

Secondary outcome measures

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%

Decreased appetite

38%

Fatigue

35%

Confusional state

31%

Hypokalaemia

31%

Diarrhoea

31%

Tachycardia

27%

Constipation

27%

Back pain

27%

Hypophosphataemia

23%

Dizziness

23%

Platelet count decreased

23%

Tremor

23%

B-cell lymphoma

23%

White blood cell count decreased

19%

Oedema peripheral

19%

Neutropenia

19%

Cough

19%

Hypogammaglobulinaemia

19%

Hyponatraemia

19%

Tachypnoea

19%

Agitation

15%

Alanine aminotransferase increased

15%

Thrombocytopenia

15%

Chills

15%

Dyspnoea

15%

Hypomagnesaemia

15%

Sinus tachycardia

15%

Dysphagia

12%

Hypertension

12%

Vomiting

12%

Abdominal pain

12%

Aspartate aminotransferase increased

12%

Pain

12%

Malaise

12%

Myalgia

12%

Hypoxia

12%

Arthralgia

12%

Hyperglycaemia

12%

Covid-19

12%

Peripheral sensory neuropathy

Hyperhidrosis

Aphasia

Pancytopenia

Muscular weakness

Pneumonia

Encephalopathy

Eye pain

Gait disturbance

Oral candidiasis

Urinary tract infection

Sepsis

Blood creatinine increased

Acute myeloid leukaemia

Insomnia

Somnolence

Dysuria

Asthenia

Lymphocyte count decreased

Pleural effusion

Covid-19 pneumonia

Respiratory failure

Febrile neutropenia

Embolism

Depression

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Axicabtagene Ciloleucel and Rituximab Combination

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

~700

Cyclophosphamide

1995

Completed Phase 3

~3780

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,466 Previous Clinical Trials

484,352 Total Patients Enrolled

10 Trials studying Recurrence

600 Patients Enrolled for Recurrence

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

Recurrence Research Study Groups: Re-Stimulated Tumor-Infiltrating Lymphocytes and interleukin-2

Recurrence 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been previous experiments that have centered around Cyclophosphamide?

"Currently, 841 clinical trials are researching the effects of Cyclophosphamide with 156 in Phase 3. Amongst these locations, Philadelphia has a significant presence but there are 28 058 sites worldwide participating in this research endeavour."

Answered by AI

Are there any open enrollment opportunities for this clinical trial?

"Unfortunately, the trial is not currently recruiting. The information was first published on January 1st 2015 and last updated on June 1st 2022. If you are searching for alternative studies, there are 104 trials actively seeking participants with recurrent platinum resistant high grade serous ovarian fallopian tube or primary peritoneal cancer and 841 clinical trials related to cyclophosphamide that are accepting patients."

Answered by AI

In what clinical scenarios is Cyclophosphamide regularly employed?

"Cyclophosphamide can be a successful means of managing metastatic melanoma, multiple sclerosis, and mixed-cell type lymphoma."

Answered by AI

Has Cyclophosphamide been issued the green light from the FDA?

"This is an early stage trial, so there has been limited research conducted to prove its efficacy and safety. As such, this medication was given a score of 1 by our team at Power."

Answered by AI

What is the cap on patients that are taking part in this medical experiment?

"This trial has closed recruitment, as the last edit was made on June 1st 2022. However, there are currently 104 studies actively accepting patients with recurrent cancer and 841 trials for Cyclophosphamide open to participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2015. ""Re-Stimulated" TILs And IL-2 Therapy for Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01883297.

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