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Chemotherapy
Adoptive Cell Transfer + Immunotherapy for Melanoma
Phase 2
Waitlist Available
Led By Rodabe N. Amaria, MD
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 be HLA-A2 for cohort A
Patients must have ECOG performance status 0, 1 or 2 and/or KPS > 50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up clinical evaluation during first 70 days, ct scan at 6-8 weeks (+/- 7 days) after cell infusion.
Awards & highlights
Study Summary
This trial is studying three different combinations of treatment as compared to treatment with T cells and high dose IL-2 alone in order to find which combination is the most effective in treating patients with melanoma.
Who is the study for?
This trial is for patients over 12 years old with metastatic melanoma, including those who have not responded well to B-RAF inhibitors or have brain lesions. Participants must be in good health overall, with proper kidney function and no severe illnesses affecting the heart, lungs, or immune system. Pregnant women and individuals with rapid disease progression or significant psychiatric conditions are excluded.Check my eligibility
What is being tested?
The study tests whether adding dendritic cell immunization to T-cell therapy improves the persistence of infused T cells in fighting melanoma compared to T-cell therapy alone. It also examines if this combination enhances anti-tumor activity and migration of T cells to tumor sites across different cohorts.See study design
What are the potential side effects?
Potential side effects include reactions from high doses of interleukin-2 (IL-2), such as flu-like symptoms, low blood pressure, nausea; effects from chemotherapy like hair loss, mouth sores; risks associated with adoptive cell transfer may involve fever and chills.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am HLA-A2 positive.
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I can care for myself and am up more than 50% of my waking hours.
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My melanoma has spread and can be measured.
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I can sit up by myself or with help.
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I am on a B-RAF inhibitor but my cancer did not improve or got worse.
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My melanoma has spread or is in stage III.
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I am 12 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ clinical evaluation during first 70 days, ct scan at 6-8 weeks (+/- 7 days) after cell infusion.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~clinical evaluation during first 70 days, ct scan at 6-8 weeks (+/- 7 days) after cell infusion.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Longitudinal Immune Response in Cohort D
Objective Response (OR)
Overall response rate (ORR) of TIL generated with the TIL 3.0 pre-REP methodology in Cohort E
Trial Design
5Treatment groups
Experimental Treatment
Group I: Group E: Chemotherapy + IL-2 plus T-Cells + VaccineExperimental Treatment6 Interventions
Chemotherapy and IL-2 plus T-cells and the vaccine of dendritic cells received by vein (IV) about 4 hours after T-cells and again on Day 21 (+/- 7 days). Cyclophosphamide 60 mg/kg/d IV over 2 hours Days -7 and -6 (with Mesna) and Fludarabine 25 mg/m^2 IV daily Days -5 to -1 before T cell infusion. On Day 0, up to 1.5 x 10^11 T cells IV infusion over 30-60 minutes. Interleukin-2 12-16 hours after T cell infusion at standard dose of 720,000 IU/kg as intravenous bolus over 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26.
Group II: Group D: Leptomeningeal DiseaseExperimental Treatment2 Interventions
T-cells: 5.0x109 TIL administered on Day 1 and 10x109 TIL on Day 15.
IL-2: 1.2 MIU of IL- 2 on Days 2, 4, 9, 11, 16 and 18 as tolerated. After this period, patient receives twice weekly IL-2 that will be gradually changed to weekly IL-2. After 4-6 weeks, patients switched to IL-2.
Group III: Group C: Prior Treatment with BRAF InhibitorExperimental Treatment6 Interventions
Chemotherapy and IL-2 plus T-cells and the vaccine of dendritic cells received by vein (IV) about 4 hours after T-cells and again on Day 21 (+/- 7 days). Cyclophosphamide 60 mg/kg/d IV over 2 hours Days -7 and -6 (with Mesna) and Fludarabine 25 mg/m^2 IV daily Days -5 to -1 before T cell infusion. On Day 0, up to 1.5 x 10^11 T cells IV infusion over 30-60 minutes. Interleukin-2 12-16 hours after T cell infusion at standard dose of 720,000 IU/kg as intravenous bolus over 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26.
Group IV: Group B: Chemotherapy + IL-2 plus T-Cells + VaccineExperimental Treatment6 Interventions
Chemotherapy and IL-2 plus T-cells and the vaccine of dendritic cells received by vein (IV) about 4 hours after T-cells and again on Day 21 (+/- 7 days). Cyclophosphamide 60 mg/kg/d IV over 2 hours Days -7 and -6 (with Mesna) and Fludarabine 25 mg/m^2 IV daily Days -5 to -1 before T cell infusion. On Day 0, up to 1.5 x 10^11 T cells IV infusion over 30-60 minutes. Interleukin-2 12-16 hours after T cell infusion at standard dose of 720,000 IU/kg as intravenous bolus over 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26.
Group V: Group A: Chemotherapy + IL-2 plus T-cellsExperimental Treatment5 Interventions
Cyclophosphamide 60 mg/kg/d by vein (IV) over 2 hours Days -7 and -6 (with Mesna) and Fludarabine 25 mg/m^2 IV daily Days -5 to -1 before T cell infusion. On Day 0, up to 1.5 x 10^11 T cells IV infusion over 30-60 minutes. Interleukin-2 12-16 hours after T cell infusion at standard dose of 720,000 IU/kg as intravenous bolus over 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26.
Group A has been closed to new patient entry as of January 14, 2016.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Aldesleukin
FDA approved
Cyclophosphamide
FDA approved
Coenzyme M
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,931,923 Total Patients Enrolled
557 Trials studying Melanoma
192,003 Patients Enrolled for Melanoma
Key Biologics, LLCIndustry Sponsor
1 Previous Clinical Trials
71 Total Patients Enrolled
Prometheus LaboratoriesIndustry Sponsor
26 Previous Clinical Trials
3,566 Total Patients Enrolled
4 Trials studying Melanoma
99 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor has noted a quick worsening of my nerve-related symptoms.I had a heart stress test within the last 6 months.You have a serious mental health condition that could affect your ability to understand the study or make immunotherapy treatment unsafe for you.I may have small brain lesions (≤1cm) or larger treated ones not considered active.I can care for myself and am up more than 50% of my waking hours.My disease is quickly getting worse and I have limited treatment options.I am not pregnant and have had a period in the last year without being sterilized.I can take care of myself and am up and about more than half of my waking hours.I am currently receiving IT IL-2 treatment for LMD.I have not taken B-RAF or MEK inhibitors in the last 7 days.My lung function tests are above 65% of what is expected.I am HLA-A2 positive.Your body has enough infection-fighting white blood cells.You will need to take a pregnancy test within a week before starting the treatment.I can swallow.You need to be able to have an MRI with a special dye.I've had recent scans of my brain and body before starting lymphodepletion.My cancer has spread to my brain and is getting worse quickly.My melanoma has spread and can be measured.I can sit up by myself or with help.Patients must have enough TIL (tumor-infiltrating lymphocytes) available for the study.I have received cancer-killing medication within the last four weeks.I have had immunotherapy, targeted therapy, or no prior therapy.I've had a brain scan within the last 6 months, or will have one for this trial.Your platelet count is 75,000 or more per cubic millimeter.Your blood creatinine level is lower than or equal to 1.6 mg/dl.Your hemoglobin level is 8.0 grams per deciliter or higher.My cancer responded well to B-RAF treatment.I am not currently on B-RAF treatment.I am on a B-RAF inhibitor but my cancer did not improve or got worse.Your liver enzyme levels (ALT) are not too high.My melanoma has spread or is in stage III.My immune system is functioning well after treatment.Your total bilirubin level is lower than 2.0 mg/dl, unless you have Gilbert's Syndrome, in which case it should be lower than 3.0 mg/dl.I will use birth control for four months after my treatment starts.I am in Cohort A and will be receiving a treatment involving TIL, with or without Dendritic cells.I have leptomeningeal disease confirmed by MRI, CSF test, or surgery.I am 12 years old or older.I have used steroids recently, except for low-dose daily use.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Group D: Leptomeningeal Disease
- Group 2: Group A: Chemotherapy + IL-2 plus T-cells
- Group 3: Group B: Chemotherapy + IL-2 plus T-Cells + Vaccine
- Group 4: Group E: Chemotherapy + IL-2 plus T-Cells + Vaccine
- Group 5: Group C: Prior Treatment with BRAF Inhibitor
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
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.
What is the maximum capacity for participation in this clinical trial?
"This clinical trial is no longer accepting applications. It was initially posted on February 1st 2006 and the most recent update was August 18th 2022. If you are searching for alternative studies, there are 754 trials recruiting patients with melanoma and 929 trials currently enrolling participants for Intrathecal T-Cell research."
Answered by AI
Has the FDA given sanction to Intrathecal T-Cells for therapeutic use?
"Our team at Power has assessed the safety of Intrathecal T-Cells to be a 2 since this is only in its second phase and there are limited clinical studies backing up efficacy."
Answered by AI
What conditions can be addressed through utilization of Intrathecal T-Cells?
"Intrathecal T-Cells is regularly administered to individuals suffering from multiple sclerosis, as well as those struggling with leukemias, myelocytic diseases, acute illnesses and retinoblastoma or histiocytic lymphoma."
Answered by AI
Are there openings for this trial at present?
"This clinical trial is currently not seeking any new participants. Initially uploaded on February 1st 2006 and last modified August 18th 20212, the study has closed its participant recruitment process for now. However, there are 754 trials aiming to recruit people with melanoma and 929 studies actively enrolling individuals who require intrathecal T-Cells treatments available right now."
Answered by AI
Has research been conducted regarding Intrathecal T-Cells in the past?
"At present, 929 Intrathecal T-Cell studies are in progress with 163 of those being Phase 3 clinical trials. Philadelphia is the epicentre for these sorts of investigations but other centres across 28723 locations are also carrying out research on this therapy."
Answered by AI
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