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Metastatic MelanomaNCT01005745

Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma

A study testing Surgery, Administration of Lymphodepletion and Adoptive Cell Transfer in people with Metastatic Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall purpose of this research study is to find a better way to treat melanoma. This will be a single arm exploratory trial to evaluate prospectively the feasibility of, the toxicities of, and the persistence of TIL which can survive in vivo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
Surgery, Administration of Lymphodepletion and Adoptive Cell Transfer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
20 Oct 2009to 18 Aug 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have unresectable metastatic stage IV melanoma or stage III in-transit or regional nodal disease.
  • Residual measurable disease after resection of target lesion(s) for TIL growth
  • Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 -1. ECOG performance status of 0-1 will be inferred if the patient's level of energy is ≥ 50% of baseline.
  • Patients may be treatment-naïve or may have been previously treated for metastatic disease.
  • Patients with a negative pregnancy test (urine or serum) must be documented at screening for women of childbearing potential (WOCBP).
  • Adequate renal, hepatic and hematologic function, including creatinine of less than or equal to 1.7 gm/dL, total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dL, aspartic transaminase (AST) and alanine transaminase (ALT) of less than 3X institutional upper limit of normal (ULN), hemoglobin of 8 gm/dL or more, white blood count (WBC) of 3000 per mm³ and total granulocytes of 1000 per mm³ or more, and platelets of 100,000 per mm³ or more.
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  • Patients must have a positive screening Epstein-Barr virus (EBV) antibody titre on screening test.
  • Patients with antibiotic allergies per se are not excluded; although the production of TIL for adoptive transfer includes antibiotics, extensive washing after harvest will minimize systemic exposure to antibiotics.
  • Patients that had previously grown sterile, validated TIL under Good Manufacturing Practices (GMP) conditions on Moffitt Clinical trial protocol 15375 (Use of Excess Melanoma Tumor Specimens Not Required for Diagnostic Purposes for Validation of Tumor Infiltrating Lymphocyte [TIL] Growth Procedures) meeting the above criteria may be consented and enrolled in the current trial using the previously established TIL stored in the Cell therapies Core facility for up to 2 years.
  • At screening, patients with ≤ 3 untreated central nervous system (CNS) metastases may be included provided none of the untreated lesions are > 1 cm in greatest dimension, and there is no peri-tumoral edema present on brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] if MRI is contraindicated).
  • At screening, patients with CNS metastases treated with either surgical resection and/or radiation therapy may be included. Patients may be included if the largest lesion is ≤ 1 cm, and there is no evidence of progressive CNS disease on brain imaging at least 28 days after treatment.
  • At screening, patients may be included if the largest lesion is > 1 cm or > 3 in number, and there is no evidence of progressive CNS disease on brain imaging at least 90 days after treatment with surgery and/or radiation therapy.
  • All laboratory and imaging studies must be completed and satisfactory within 30 days of signing the consent document.

Who cannot join

  • Patients with active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system are excluded.
  • Patients testing positive for human immunodeficiency virus (HIV) titre, Hepatitis B surface antigen, Hepatitis C antibody, Human T-lymphotropic virus (HTLV) I or II antibody, or both rapid plasma reagent (RPR) and fluorescein treponemal antibodies (FTA) positive are excluded.
  • Patients who are pregnant or nursing
  • Patients needing chronic, immunosuppressive systemic steroids
  • Patients with autoimmune diseases that require immunosuppressive medications
  • Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated
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  • Patients with > 3 untreated CNS metastases or evidence of peri-tumoral edema will be excluded.
  • Patients with ≤ 3 untreated CNS metastases but with at least one lesion >1 cm or peri-tumoral edema will be excluded.
  • Patients with treated CNS metastases > 1 cm or > 3 in number will be excluded if there is evidence of progressive CNS disease on brain imaging at least 90 days after treatment with surgery and/or radiation therapy.
  • Inability to comprehend and give informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

The overall purpose of this research study is to find a better way to treat melanoma. This will be a single arm exploratory trial to evaluate prospectively the feasibility of, the toxicities of, and the persistence of TIL which can survive in vivo.

Read the detailed description

Patients are being offered admission to this study to test the side effects of an investigational treatment prepared from special immune cells (T cells) specific for melanoma. A T-cell is a type of lymphocyte. Lymphocytes are a type of white blood cell that protect people from viral infections; help other cells fight bacterial and fungal infections; produce antibodies; fight cancers; and coordinate the activities of other cells in the immune system. These special immune cells will be taken from a sample of the patient's tumor tissue that will be surgically removed from their body and grown in the laboratory. They will then given back to the patient in their veins. These cells are called tumor infiltrating lymphocytes (TIL). We wish to study the side effects of TIL when they are given with two chemotherapy drugs to temporarily decrease the patient's own immune cells and a drug called Interleukin-2 (IL-2). The two chemotherapy drugs called fludarabine and cytoxan are used to greatly reduce the number of normal lymphocytes circulating in the patient's body, called lymphodepletion, so that there will be more "space" for the cancer fighting lymphocytes (T-cells) that will be infused in their veins. We wish to find out how often these cells can shrink or slow the growth of the patient's melanoma. We also wish to find out the effects of lymphodepletion followed by TIL and high dose IL-2 on the patient's immune system. The lymphodepletion followed by TIL and high dose IL-2 is experimental, and has not been proven to help treat melanoma.

The IL-2 has been approved by the Food and Drug Administration (FDA) for the treatment of metastatic melanoma that cannot be surgically removed. The chemotherapy drugs cytoxan and fludarabine used for lymphodepletion have been approved by the FDA, but not for the treatment of metastatic melanoma.

The combination of lymphodepletion followed by TIL and high dose IL-2 is not FDA approved but the FDA is permitting its use in this study.

Being tested
Surgery, Administration of Lymphodepletion, Adoptive Cell Transfer, High Dose IL-2
Keywords
skin, adoptive cell therapy, tumor-infiltrating lymphocytes (TIL), lymphodepletion
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    Also called Tumor Infiltrating Lymphocytes (TIL), T-cell, lymphocyte

    Surgery to remove a tumor for growth of TIL

  • Administration of LymphodepletionDrug

    Also called Cytoxan

    Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo

  • Adoptive Cell TransferOther

    T-cell infusion

  • High Dose IL-2Drug

    Also called Interleukin-2, Aldesleukin, Proleukin

    Beginning approximately 12 - 16 hours after cell infusion.

Study groups in NCT01005745
Study groupRoleWhat they receive
TIL With High Dose IL-2ExperimentalDay -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours. Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days. Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused. Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Receives: Procedure: Surgery; Drug: Administration of Lymphodepletion; Other: Adoptive Cell Transfer; Drug: High Dose IL-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth

    Feasibility was the primary endpoint of this trial, defined as a patient who can grow and expand T-cells: Number of participants with fragments cultured; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture and were cocultured with autologous or human leukocyte antigen (HLA)-matched tumor cells for interferon(IFN)-γ production; Number of participants with fragments that produced IFN-γ in response to autologous or HLA-matched tumor cells.

    Measured: 192 Days Post Surgical Resection

Secondary outcomes (1)

  1. Number of Participants With Objective Response (OR)

    OR is defined as the patient being alive at Day 70 and tumor size evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be a complete response or partial response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Evaluations were made by computed tomography (CT) scan approximately 6 to 8 weeks after the cell infusion, or CT scan approximately 10 weeks after the cell infusion, or by clinical evaluation during the first 70 days.

    Measured: Average of 10 Months Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2009 (estimated)
  2. Study start20 Oct 2009
  3. Primary completion31 Jan 2014
  4. Study completion18 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01005745
Sponsor's protocol ID
MCC-15781
Status last verified
Dec 2025
First submitted
27 Oct 2009
Last updated
19 Dec 2025
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Surgery, Administration of Lymphodepletion and Adoptive Cell Transfer in people with Metastatic Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth (time frame: 192 Days Post Surgical Resection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01005745.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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