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Cytokine

Immunotherapy + Chemotherapy for Metastatic Melanoma

Phase 2
Waitlist Available
Led By Adi Diab
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' at screening visit
ECOG/Zubrod performance status of '0-1'
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying how well white blood cells taken from a person's own body, when mixed with other drugs, work in treating patients with melanoma that has spread to another place in the body.

Who is the study for?
This trial is for adults with metastatic melanoma who can consent, use birth control, and have a good performance status. They must not have had recent cancer treatments or major surgery and should be free of certain health conditions. Participants need to express HLA-A2, have measurable tumors, and show specific staining results.Check my eligibility
What is being tested?
The study tests if one's own modified white blood cells (CD8+ T cells), combined with cyclophosphamide (chemotherapy), aldesleukin (biological therapy), and ipilimumab (immunotherapy antibody) can effectively treat metastatic melanoma by killing cancer cells or stopping their growth.See study design
What are the potential side effects?
Potential side effects include immune system reactions that may affect organs, infusion-related responses, fatigue from the body's increased defense activity against cancer cells, chemotherapy-induced nausea or hair loss, and possible low blood counts leading to anemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am fully active and can carry on all my pre-disease activities without restriction.
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It has been over 4 weeks since my last major cancer treatment or surgery.
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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 test when it spread.
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My cancer has been tested for the BRAF V600 mutation.
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I am willing to use birth control as required.
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My cells test positive for HLA-A2.
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I can have needles inserted without difficulty.
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I am using effective birth control to prevent pregnancy during the study.
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My melanoma tests positive for Melan-A or SLC45A2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of toxicity
Overall response

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (T cells, chemo, aldesleukin, ipilimumab)Experimental Treatment5 Interventions
Beginning 48 to 72 hours prior to T cell infusion, patients receive cyclophosphamide IV over 30-60 minutes. Patients then receive autologous CD8+ melanoma-specific T cells IV over 30-60 minutes on day 0, aldesleukin SC BID on days 0-13 and 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
Ipilimumab
2014
Completed Phase 3
~2620
Cyclophosphamide
1995
Completed Phase 3
~3770
Autologous CD8+ Melanoma Specific T Cells
2015
Completed Phase 2
~20
Aldesleukin
2012
Completed Phase 4
~1620

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,651 Total Patients Enrolled
557 Trials studying Melanoma
193,217 Patients Enrolled for Melanoma
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,786 Total Patients Enrolled
102 Trials studying Melanoma
25,319 Patients Enrolled for Melanoma
Adi DiabPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
55 Total Patients Enrolled
2 Trials studying Melanoma
55 Patients Enrolled for Melanoma

Media Library

Aldesleukin (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT02027935 — Phase 2
Melanoma Research Study Groups: Treatment (T cells, chemo, aldesleukin, ipilimumab)
Melanoma Clinical Trial 2023: Aldesleukin Highlights & Side Effects. Trial Name: NCT02027935 — Phase 2
Aldesleukin (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02027935 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been recruited for participation in this trial?

"This trial has not been searching for candidates since February 2nd 20202. For those that are interested in other research opportunities, there are 765 clinical trials related to melanoma and 1,148 studies examining Autologous CD8+ Melanoma Specific T Cells currently recruiting patients."

Answered by AI

In what therapeutic capacities is Autologous CD8+ Melanoma Specific T Cells most frequently employed?

"Autologous CD8+ Melanoma Specific T Cells are capable of treating a variety of conditions, particularly lung cancer, multiple sclerosis and acute myelocytic leukemia."

Answered by AI

Are there any prior research papers outlining the impact of Autologous CD8+ Melanoma Specific T Cells?

"Currently, 1148 clinical trials are assessing the efficacy of Autologous CD8+ Melanoma Specific T Cells with 193 studies in Phase 3. Philadelphia, Pennsylvania is not the only locale hosting such trials as there exists 48393 locations operating these medical experiments."

Answered by AI

What potential risks are associated with Autologous CD8+ Melanoma Specific T Cells treatment?

"Autologous CD8+ Melanoma Specific T Cells has been determined to have a safety rating of 2 as it is currently in Phase 2 clinical trials and there are some data demonstrating its security, though no evidence yet confirming efficacy."

Answered by AI

Are there still vacancies for participation in this clinical trial?

"According to records on clinicaltrials.gov, this medical experiment is not presently recruiting patients. It was initially published in 1/22/2015 and amended lastly on 2/2/2022; however, there are 1913 other studies currently enlisting volunteers right now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma
2015. "CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02027935.
~2 spots leftby Apr 2025
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