Your session is about to expire
← Back to Search
CAR T-cell Therapy
Genetically Modified T-Cells + Aldesleukin for Melanoma
Phase 1
Waitlist Available
Led By Rodabe N Amaria
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have metastatic melanoma or stage III in-transit, subcutaneous, or regional nodal disease
Patients must have a lesion amenable to resection or the collection of up to 5 needle core samples for the generation of TIL
Must not have
Patients with prior bone marrow or stem cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 20 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial is testing genetically modified T-cells followed by aldesleukin to treat melanoma. T-cells are a type of white blood cell that help the body fight infections. Genes that may help the T-cells recognize melanoma cells are placed into the T-cells in the laboratory. Adding these genes to the T cells may help them kill more tumor cells when they are put back in the body. Aldesleukin may enhance this effect by stimulating white blood cells to kill more melanoma cells.
Who is the study for?
This trial is for adults with stage III-IV melanoma who have adequate lung function, no severe psychiatric diseases, and are not pregnant or nursing. Participants must not have had recent cancer treatments, organ transplants, significant medical illnesses, or be on chronic steroids. They need measurable melanoma lesions suitable for T-cell generation and agree to use birth control.
What is being tested?
The trial tests genetically modified T-cells designed to target melanoma followed by aldesleukin (a substance that can boost the immune system). It aims to find the best dose and observe side effects. The process involves modifying patients' own T-cells in a lab before reintroducing them into their bodies.
What are the potential side effects?
Potential side effects may include reactions related to the immune system's enhancement such as flu-like symptoms from aldesleukin (fever, chills), fatigue, risk of infection due to white blood cell changes, and possible tissue damage at injection sites.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma has spread or is in stage III.
Select...
I have a tumor that can be surgically removed or sampled.
Select...
I have a melanoma spot that can be biopsied and is at least 1 cm big.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a bone marrow or stem cell transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
(Cohort A) Generation of TGF alpha (TGFa)-DNRII and NGFR transduced tumor infiltrating lymphocytes (TILs)
(Cohort B) The primary endpoint of growing enough TIL for patient treatment and sample size is 15 patients.
Secondary study objectives
(Cohort A) Number of DNRII transduced cells
(Cohort A) Number of NGFR transduced cells at infusion
(Cohort A) Number of NGFR transduced cells based on tumor biopsy
+1 moreAwards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, autologous T-cell immunotherapy)Experimental Treatment6 Interventions
Patients receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and TGFb DNRII-transduced autologous TIL and NGFR-transduced autologous T lymphocytes IV over up to 4 hours on day 0. Patients then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
FDA approved
Cyclophosphamide
FDA approved
Fludarabine
FDA approved
NGFR-transduced Autologous T Lymphocytes
2015
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,774 Total Patients Enrolled
2 Trials studying Cutaneous Melanoma
5,053 Patients Enrolled for Cutaneous Melanoma
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,136 Total Patients Enrolled
5 Trials studying Cutaneous Melanoma
146 Patients Enrolled for Cutaneous Melanoma
Rodabe N AmariaPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
143 Total Patients Enrolled
1 Trials studying Cutaneous Melanoma
53 Patients Enrolled for Cutaneous Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been active and mostly self-sufficient in the last month.I had a brain scan within the last 30 days.My melanoma has spread or is in stage III.I have a tumor that can be surgically removed or sampled.My lung function tests are within normal limits.I haven't had cancer treatment or specific inhibitors in the last 4 weeks/7 days.You have a serious mental health condition that may affect your ability to understand the study or make immunotherapy unsafe for you.You have had a solid organ transplant.Your platelet count is at least 100,000 per cubic millimeter.I have a primary immune disorder but take less than 10 mg/day of prednisone.My immune system is functioning well after treatment, with no serious infections.I have had a bone marrow or stem cell transplant.I am currently taking strong cancer drugs and will be assessed for trial suitability.I have enough immune cells available for cancer treatment.I have small brain lesions, approved by my doctor for this treatment.I will use birth control for four months after starting treatment and throughout the study. I have a negative pregnancy test if applicable.I have used steroids recently or need to use them for my condition.You have enough infection-fighting white blood cells in your body.I can care for myself and am up and about more than 50% of my waking hours.I have had immunotherapy, targeted therapy, or no previous cancer treatment.I had a heart stress test within the last 6 months.Your liver enzyme level (ALT) is not more than three times the normal limit.I have a melanoma spot that can be biopsied and is at least 1 cm big.Your hemoglobin level is 8.0 grams per deciliter or higher.Your blood creatinine level is less than or equal to 1.6 mg/dl.Your total bilirubin level should be less than 2.0 mg/dl, unless you have Gilbert's syndrome, in which case it should be less than 3.0 mg/dl.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (chemotherapy, autologous T-cell immunotherapy)
Awards:
This trial has 3 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.