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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after end of treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Response rate
Secondary outcome measures
Frequency and severity of treatment-related adverse events
Progression-free survival
Side effects data
From 2014 Phase 2 trial • 28 Patients • NCT0135024593%
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%
CMV reactivation
14%
Shoulder pain
14%
Hip pain
14%
Blurry vision
14%
Tachypnea
14%
Edema
14%
Ear pain
14%
Arm swelling
14%
Increased LFTs
11%
Hiccups
11%
Arm pain
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%
HHV-6 reactivation
7%
Infection
7%
Urinary frequency
7%
Hematuria
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%
Low TSH
4%
Muscle weakness
4%
Mouth ulceration
4%
Altered taste
4%
Joint aches
4%
Hypomagnesemia
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
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
~1620
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100
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
13,654 Previous Clinical Trials
40,933,051 Total Patients Enrolled
557 Trials studying Melanoma
193,131 Patients Enrolled for Melanoma
Steven A Rosenberg, M.D.Principal InvestigatorNational Cancer Institute (NCI)
37 Previous Clinical Trials
17,779 Total Patients Enrolled
28 Trials studying Melanoma
16,904 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My immune system is strong and I don't have infections that occur more often or are more severe because of weakened immunity.I have undergone cell transfer therapy with intense chemotherapy.You are expected to live for more than three months.I do not have any active major illnesses or infections affecting my heart, lungs, or immune system.I am fully active or can carry out light work.It's been over 4 weeks since my last treatment, and I've mostly recovered.I had minor surgery recently but have recovered with minimal side effects.Your heart's pumping ability is less than 45%.My previous radiation therapy prevents me from having total body irradiation.I have up to 3 brain metastases that are stable and treated if needed.I am between 18 and 66 years old.I have had heart surgery or symptoms of reduced blood flow to my heart.I am over 60 and my heart's pumping ability is reduced.It's been over 6 weeks since my last anti-CTLA4 therapy, and I've had a normal colonoscopy if I had GI toxicity.I have a condition that significantly weakens my immune system.I need to take steroid medication regularly.Your white blood cell count, red blood cell count, and platelet count are within normal range.You do not have HIV, hepatitis B, or hepatitis C.I am not pregnant or breastfeeding.I have a melanoma tumor larger than 1cm that can be surgically removed.I agree to use birth control during and for four months after treatment.My lung function is reduced, I've smoked heavily, and I have breathing problems.My liver and kidney functions are within safe ranges for the trial.
Research Study Groups:
This trial has the following groups:- Group 1: 1/ACT
- Group 2: 2/ACT + TBI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the recruitment criteria for this experiment include adults over thirty years old?
"The age range for inclusion in this trial is 18 years and older, up to 65 years old."
Answered by AI
Can you provide an estimation of the overall recruitment rate for this clinical experiment?
"Unfortunately, this medical trial is not currently open to new participants. It was first posted on March 24th 2011 and the most recent update occurred on November 19th 2022. Alternately, 829 studies are recruiting for skin cancer patients while 913 trials require Young Tumor Infiltrating Lymphocytes"
Answered by AI
Who would be the most appropriate candidates for participating in this experiment?
"This clinical study is searching for 102 people with cutaneous cancer aged between 18 and 66 years old. Major eligibility criteria include: having a resectable melanoma lesion at least 1 cm in diameter, no more than 3 brain metastases, being of appropriate age (18-66), using contraceptives while on treatment and four months afterwards, possessing an estimated life expectancy of over three months, signing a durable power of attorney form, and exhibiting ECOG 0 or 1 performance status."
Answered by AI
What other experiments have been conducted to evaluate the efficacy of Young Tumor Infiltrating Lymphocytes?
"Presently, there are 913 clinical trials studying Young Tumor Infiltrating Lymphocytes. Of those ongoing studies, 163 of them have progressed to the third phase. While a large concentration of these research initiatives can be found in Philadelphia, Pennsylvania; 28673 different institutions across North America offer this treatment option."
Answered by AI
What medical maladies typically necessitate the use of Young Tumor Infiltrating Lymphocytes?
"Young Tumor Infiltrating Lymphocytes is a common treatment option for multiple sclerosis, but can also be helpful in treating other maladies such as acute leukemia, myelocytic lymphoma, retinoblastoma and histiocytic lymphoma."
Answered by AI
Has the FDA accepted Young Tumor Infiltrating Lymphocytes as a legitimate treatment?
"There is some evidence that Young Tumor Infiltrating Lymphocytes are safe, so it receives a rating of 2. However, since this is only in the Phase 2 trial stage there is no data to confirm its efficacy."
Answered by AI
Is it feasible for people to presently participate in this trial?
"As reported on clinicaltrials.gov, this specific medical trial is not currently recruiting participants; the study was initially posted on March 24th 2011 and last updated November 19th 2022. Despite this inactive status, there are 1742 different trials that are taking in patients right now."
Answered by AI
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