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Cell Transfer Therapy

Cell Therapy + Chemo + TBI for Skin Cancer

Phase 2
Waitlist Available
Led By Steven A Rosenberg, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical performance status of ECOG 0 or 1.
More than four weeks must have elapsed since any prior systemic therapy at the time of randomization, and patients toxicities must have recovered to a grade 1 or less (except for alopecia or vitiligo). Patients must have stable or progressing disease after prior treatment.
Must not have
Prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after end of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether an experimental treatment for metastatic melanoma, which involves cell therapy, is more effective when given with chemotherapy and total body irradiation, or just with chemotherapy.

Who is the study for?
Adults aged 18-66 with metastatic melanoma, able to consent, and have a life expectancy over three months. They must be in good health otherwise, not HIV or hepatitis positive, and have a tumor suitable for cell extraction. Women can't be pregnant/breastfeeding; participants must use birth control during/after the trial.
What is being tested?
The study is testing if adding total body irradiation (TBI) to chemotherapy before cell therapy improves outcomes in metastatic melanoma patients. Participants are split into two groups: one receives just chemo while the other gets chemo plus TBI before their own grown white blood cells are reintroduced.
What are the potential side effects?
Possible side effects include reactions from high-dose aldesleukin like fatigue and heart issues, immune system suppression from chemotherapy leading to infection risk, potential complications from radiation exposure including nausea and organ damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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It's been over 4 weeks since my last treatment, and I've mostly recovered.
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I am between 18 and 66 years old.
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I have a melanoma tumor larger than 1cm that can be surgically removed.
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My liver and kidney functions are within safe ranges for the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have undergone cell transfer therapy with intense chemotherapy.
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I do not have any active major illnesses or infections affecting my heart, lungs, or immune system.
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I have had heart surgery or symptoms of reduced blood flow to my heart.
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I am over 60 and my heart's pumping ability is reduced.
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I have a condition that significantly weakens my immune system.
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I need to take steroid medication regularly.
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I am not pregnant or breastfeeding.
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My lung function is reduced, I've smoked heavily, and I have breathing problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after end of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival
Response rate
Secondary study objectives
Frequency and severity of treatment-related adverse events
Progression-free survival

Side effects data

From 2014 Phase 2 trial • 28 Patients • NCT01350245
93%
Fatigue
89%
Diarrhea
86%
Mucositis
86%
Fever
82%
Rash
71%
Tachycardia
68%
Anxiety
68%
Hypotension
64%
Insomnia
64%
Headache
61%
Abdominal pain
54%
Dyspnea
46%
Constipation
46%
Back pain
43%
Hypertension
43%
Dizziness/lightheaded
39%
Nausea
39%
Congestion
39%
Lethargic
39%
Dry mouth
36%
Cough
36%
Itching
36%
Dry skin
36%
Dysuria
32%
Epigastric pain/heartburn
32%
Nocturia
32%
Electrolyte imbalance
29%
Anorexia
29%
Chills
29%
Muscle pain
29%
Chest pain
25%
Neuropathy
25%
Decreased appetite
25%
Rigors
25%
Hyperbilirubinemia
25%
Gastroesophageal reflux disease
25%
Depression
25%
Decreased urine output
25%
Trouble sleeping
25%
Fluid overload
25%
Increased creatinine
21%
Tremors
21%
Hypoxia
21%
Leg pain
21%
Clostridium difficile
21%
Pericardial effusion
18%
Numbness/tingling
18%
Cytomegalovirus reactivation
18%
Hyponatremia
14%
Shoulder pain
14%
Hip pain
14%
CMV reactivation
14%
Blurry vision
14%
Tachypnea
14%
Edema
14%
Ear pain
14%
Arm swelling
14%
Increased LFTs
11%
Arm pain
11%
Hiccups
11%
Sweats
11%
Visual acuity change/weakness
11%
Flatulence
11%
Sore throat
11%
General pain
11%
Dysphagia
11%
Jaw pain
11%
Rhinorrhea
11%
Abdominal cramps
11%
Hypokalemia
11%
Knee pain
11%
Hemorrhoids
11%
Ventricular systolic dysfunction
11%
Pericather thrombus
11%
Photophobia
11%
Urinary incontinence
11%
Neck stiffness
11%
Dry eyes
11%
Feet pain
7%
Infection
7%
HHV-6 reactivation
7%
Hematuria
7%
Urinary frequency
7%
Malaise
7%
Pain at PICC site
7%
Agitation
7%
HHV-6 infection
7%
Rectal pain
7%
Hallucinations
7%
Parasthesia of foot
7%
Erythema
7%
Hand pain
7%
Cold-like symptoms
7%
Flushing/erythema
7%
Vomiting
7%
Hyperpigmentation
7%
Vasovagal syncope
7%
Upper respiratory infection
7%
Wheezing
7%
Heel/ankle pain
7%
Atrial fibrillation
7%
Dry cough
7%
Bloated feeling
7%
Pleural effusion
7%
Retinal hemorrhage
7%
Neck pain
7%
Bradycardia
7%
Orthostatic hypotension
7%
Hyperglycemia
7%
Altered mental status
7%
Hives
7%
Hyperlipidemia
7%
Bone pain
7%
Dehydration
7%
Thrush
4%
Muscle weakness
4%
Mouth ulceration
4%
Altered taste
4%
Low TSH
4%
Hypomagnesemia
4%
Joint aches
4%
Skin irritation
4%
Swollen ankles
4%
Urinary retention
4%
Sinusitis
4%
Night sweats
4%
Eye pain
4%
Paresthesia
4%
Indigestion
4%
Bone marrow cellularity
4%
Colitis
4%
BK cystitis
4%
Subdural hematoma
4%
Brain injury from subdural hematoma
4%
Sepsis
4%
Cholecystitis
4%
Acute infusion reaction
4%
Oral discomfort
4%
Ulcer
4%
Palpitations
4%
Tongue sores
4%
Odynophagia
4%
Alopecia
4%
Clubbing of extremities
4%
Gum pain at site of tooth extraction
4%
Cheek pain
4%
Vision - flashing lights
4%
Mild desquamation on fingers
4%
Knee - decreased range of motion
4%
Plaque on tongue
4%
Decreased sense of well-being
4%
Puffy face
4%
Leg cramping
4%
Perinephric fluid
4%
Head cold
4%
Hearing problems
4%
Diminished breath sounds
4%
BK viremia
4%
Papules
4%
Groin pain
4%
Nose dryness
4%
Burning of soles of hands and feet
4%
Mild distress
4%
Frustration
4%
Meningitis
4%
Orange urine
4%
Seizures
4%
Hypernatremia
4%
Muscle spasms
4%
Abdominal distension
4%
Penile lesion
4%
Polyuria
4%
Aspiration
4%
Internal jugular thrombus
4%
Opisthotonus
4%
Allergic rhinitis
4%
Blisters
4%
Gastroparesis pain
4%
Neutropenic colitis
4%
Ringing in ears
4%
Hypoglycemia
4%
Hypopigmentation
4%
Speech or memory change
4%
Sensitivity to hot/cold
4%
Swollen face
4%
Pulmonary infiltrates
4%
Pain at lung biopsy site
4%
Difficulty walking
4%
Malnutrition
4%
Weight loss
4%
Platelet infusion reaction
4%
Hot flashes
4%
Auditory hallucinations
4%
Elevated ferritin
4%
Tearing of eyes
4%
Pneumonitis
4%
Hypercholesterolemia
4%
Vagina - whitish coating
4%
Discouraged
4%
Blindness
4%
Penile/scrotum pain
4%
Penile blister
4%
Tongue lumps
4%
Nightmares
4%
Parotitis
4%
Difficulty concentrating
4%
Enlarged lymph node
4%
Volume overload
4%
Swollen eyelid
4%
Visual disturbance
4%
Shin pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
TJU 2 Step Regimen

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/ACT + TBIExperimental Treatment5 Interventions
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young TIL + highdose aldesleukin + TBI
Group II: 1/ACTExperimental Treatment4 Interventions
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young TIL + highdose aldesleukin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
2012
Completed Phase 4
~1610
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1830
Young TIL
2012
Completed Phase 2
~70
Total Body Irradiation (TBI)
2016
Completed Phase 3
~1220

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,478 Total Patients Enrolled
Steven A Rosenberg, M.D.Principal InvestigatorNational Cancer Institute (NCI)
37 Previous Clinical Trials
17,779 Total Patients Enrolled

Media Library

Young TIL (Cell Transfer Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01319565 — Phase 2
Skin Cancer Research Study Groups: 1/ACT, 2/ACT + TBI
Skin Cancer Clinical Trial 2023: Young TIL Highlights & Side Effects. Trial Name: NCT01319565 — Phase 2
Young TIL (Cell Transfer Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01319565 — Phase 2
~3 spots leftby Jun 2025
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