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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
Must not have
Steroids (at prednisone equivalent doses > 10 mg) are not permitted 3 days prior to T cell infusion and concurrently during therapy
Patients may not be on any other treatments for their cancer aside from those included in the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken high doses of steroids 3 days before and during T cell therapy.
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I am not on any cancer treatments not approved in this study.
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I have serious lung problems confirmed by my doctor.
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I am not pregnant, nursing, and if of childbearing potential, I agree to use effective contraception.
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I do not have a history of inflammatory bowel disease or any autoimmune diseases.
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My liver enzymes are high due to liver metastasis.
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I have serious heart problems.
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
Maximum tolerated dose (MTD)
Secondary study objectives
Duration of clinical response (DOR)
Incidence of toxicity
Overall response rate
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
Aldesleukin
2012
Completed Phase 4
~1610
Ipilimumab
2015
Completed Phase 3
~3070
Cyclophosphamide
2010
Completed Phase 4
~2310
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,211 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,917 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.
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