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Cytokine
Immunotherapy + Chemotherapy for Uveal Melanoma
Phase 1
Waitlist Available
Led By Sapna P Patel
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
Eastern Cooperative Oncology Group (ECOG)/ Zubrod performance status of 0-1
Expression of human leukocyte antigen (HLA)-A:0201 or HLA-A:2402
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying autologous CD8+ T cells, which are collected from patients' blood and treated to target melanoma cells, when given with other drugs to see how well they work in treating patients with metastatic uveal melanoma.
Who is the study for?
This trial is for patients with metastatic uveal melanoma. They must have measurable disease, specific human leukocyte antigen types, and be in good physical condition (ECOG/Zubrod status of 0-1). Women who can bear children and men must use contraception. Patients should not have significant heart issues or other conditions that could complicate treatment.Check my eligibility
What is being tested?
The trial tests a combination of treatments: autologous CD8+ T lymphocytes tailored to target melanoma cells, cyclophosphamide chemotherapy, aldesleukin biological therapy, and ipilimumab immunotherapy. The goal is to see if this mix works better for treating metastatic uveal melanoma.See study design
What are the potential side effects?
Potential side effects include immune system reactions leading to inflammation in various organs due to ipilimumab; blood cell count changes from cyclophosphamide; fatigue; allergic reactions; and possible infection risks from the overall weakening of the immune system.
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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My cancer cells show specific immune system markers.
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Side effects from my previous treatments are mild or back to normal, except for those that won’t improve.
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My melanoma was confirmed by a tissue examination at the time it spread or was diagnosed as high-risk.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Duration of clinical response (DOR)
Incidence of toxicity
Overall response rate
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cyclophosphamide, T-cells, aldesleukin, ipilimumab)Experimental Treatment4 Interventions
PREPARATIVE REGIMEN: Patients receive cyclophosphamide IV over 30-60 minutes on day -2.
T-CELL INFUSION: Patients receive autologous CD8+ SLC45A2-specific T lymphocytes via hepatic arterial infusion via central catheter over 60 minutes on day 0. Within 6 hours of T-cell infusion, patients also receive aldesleukin BID SC for 14 days in the absence of disease progression or unacceptable toxicity.
POST T-CELL INFUSION: Patients receive ipilimumab IV over 90 minutes on days 1, 22, 43, and 64 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Aldesleukin
2012
Completed Phase 4
~1620
Ipilimumab
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,747 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,119 Total Patients Enrolled
Sapna P PatelPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
313 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.It has been over 4 weeks since my last cancer treatment or major surgery.Your hematocrit level is at least 24% or your hemoglobin level is at least 8 g/dL.I have another cancer type but it doesn't need treatment right now.You have tested positive for HIV, Hepatitis B, or Hepatitis C.You have received another type of immunotherapy treatment that the principal investigator believes would not be safe to combine with this study's treatment.Your white blood cell count is less than or equal to 2000 per microliter.Your platelet count is less than or equal to 50,000.I haven't taken high doses of steroids 3 days before and during T cell therapy.I haven't had vaccines for infectious diseases around the time I received ipilimumab.I am not on any cancer treatments not approved in this study.My cancer cells show specific immune system markers.I am using birth control to prevent pregnancy during the study.I am fully active or restricted in physically strenuous activity but can do light work.Side effects from my previous treatments are mild or back to normal, except for those that won’t improve.My side effects from previous treatments have mostly gone away or are permanent.Your platelet count is higher than 50,000.I have serious lung problems confirmed by my doctor.My cancer can be measured by touch or scan.I am not pregnant, nursing, and if of childbearing potential, I agree to use effective contraception.I do not have a history of inflammatory bowel disease or any autoimmune diseases.My liver enzymes are high due to liver metastasis.I have serious heart problems.Your hematocrit (Hct) level is 24% or lower, or your hemoglobin (Hb) level is 8 grams per deciliter or lower.I am a man willing to use birth control if my partner can become pregnant.I am willing and able to give my consent for treatment at least a week before T cell infusion.My melanoma was confirmed by a tissue examination at the time it spread or was diagnosed as high-risk.Your white blood cell count is too low.Your creatinine levels are three times higher than the normal range.Your bilirubin levels are three times higher than the normal range.My cancer has spread to my liver.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cyclophosphamide, T-cells, aldesleukin, ipilimumab)
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.
Are there still vacancies available in this experiment for participants?
"According to the information posted on clinicaltrials.gov, this investigation is actively hunting for qualified participants; it was initially published on September 8th 2017 and the listing most recently saw an update on October 6th 2022."
Answered by AI
What risks do Autologous CD8+ SLC45A2-specific T Lymphocytes pose to users?
"Autologous CD8+ SLC45A2-specific T Lymphocytes has limited data in terms of efficacy and safety, thus our team at Power rates its risk as a 1."
Answered by AI
What prior research has been completed regarding Autologous CD8+ SLC45A2-specific T Lymphocytes?
"Presently, 1148 clinical trials are underway studying Autologous CD8+ SLC45A2-specific T Lymphocytes; of which 193 are in the final stage. Most of these experiments take place within Philadelphia, Pennsylvania but there exist 48407 other sites conducting similar research."
Answered by AI
What medical maladies can be managed through the application of Autologous CD8+ SLC45A2-specific T Lymphocytes?
"Autologous CD8+ SLC45A2-specific T Lymphocytes is a common cancer treatment for lung cancers and can also be beneficial in the management of acute myelocytic leukemia, multiple sclerosis, and unresectable melanoma."
Answered by AI
How many participants are currently being recruited for this clinical research?
"Affirmative. Clinicaltrials.gov reports that this clinical trial was first uploaded on September 8th, 2017 and has been recently updated on October 6th, 2022. The study is seeking 30 individuals from one medical centre."
Answered by AI
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