Evidence map›Paper›PMID 18809613›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2008

Adoptive cell therapy for patients with metastatic melanoma: evaluation of intensive myeloablative chemoradiation preparative regimens.

Mark E Dudley, James C Yang, Richard Sherry, Marybeth S Hughes, Richard Royal, Udai Kammula, Paul F Robbins, JianPing Huang, Deborah E Citrin, Susan F Leitman and 10 more

6 registry-linked trialsOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 744 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
744citing papers in PubMed, 1 pooled it
50.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01319565 phase2completednot on this mapstarted 2011, after this paper: background citation

A Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Short-Term Cultured Tumor-Infiltrating Lymphocytes Plus IL-2 Following Either a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2011 to 2024Enrolled102ConditionsMetastatic Melanoma, Skin CancerArmsAldesleukin, Cyclophosphamide, Fludarabine, Young TIL, Total Body Irradiation (TBI)
NCT01457131 phase1terminatednot on this mapstarted 2011, after this paper: background citation

Phase I/II Study of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Gene Engineered Lymphocytes Cotransduced With Genes Encoding IL-12 and Anti-NY ESO-1 TCR

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2011 to 2013Enrolled2ConditionsMetastatic Cancer, Metastatic Melanoma, Metastatic Renal CancerArmsFludarabine, Cyclophosphamide, IL-12 &amp, Anti-NY ESO1 TCR PBL
NCT01585415 phase1terminatednot on this mapstarted 2012, after this paper: background citation

A Pilot Trial of the Combination of Vemurafenib With Adoptive Cell Therapy in Patients With Metastatic Melanoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2012 to 2016Enrolled12ConditionsMetastatic Cancer, MelanomaArmsVemurafenib, Young TIL, Cyclophosphamide, Fludarabine, Aldesleukin
NCT01967823 phase2completednot on this mapstarted 2013, after this paper: background citation

Phase II Study of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2013 to 2020Enrolled11ConditionsMelanoma, Meningioma, Breast Cancer, Non-Small Cell Lung CancerArmsAnti-NY ESO-1 mTCR PBL, Cyclophosphamide, Fludarabine, Aldesleukin
NCT01993719 phase2completednot on this mapstarted 2013, after this paper: background citation

A Phase II Study for Metastatic Melanoma Using High-Dose Chemotherapy Preparative Regimen Followed by Cell Transfer Therapy Using Tumor-Infiltrating Lymphocytes Plus IL-2 With the Administration of Pembrolizumab in the Retreatment Arm

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2013 to 2022Enrolled33ConditionsMetastatic MelanomaArmsAldesleukin, Fludarabine, Cyclophosphamide, Young TIL, Pembrolizumab
NCT02062359 phase2terminatednot on this mapstarted 2014, after this paper: background citation

Phase II Study of CD62L+-Derived T Lymphocytes Transduced With a T Cell Receptor Recognizing the NY-ESO-1 Antigen and Aldesleukin Following Lymphodepletion in Patients With NY-ESO-1 Expressing Melanoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2014 to 2016Enrolled2ConditionsMetastatic Cancer, Metastatic MelanomaArmsAnti-NY ESO-1 T cell receptor (TCR) cluster of differentiation 62L (CD62L)+ cells, Aldesleukin, Cyclophosphamide, Fludarabine
3 · Its place in the literature

Who cites it

744 citing papers in PubMed, 1 synthesis or guideline pooled it, 1,320 citations in OpenAlex.

  1. Pooled it
  2. Effective TIL Therapy for Patients with Checkpoint-Resistant Melanoma without Lymphodepleting Regimens Requires IFNα.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Spatiotemporal dynamics of adoptively transferred stem-like CD8bioRxiv : the preprint server for biology · 2026
    Article
  20. Article

684 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 2 institutions in 1 country.

Mark E DudleySurgery Branch, National Cancer Institute, NIH, Bethesda, MD 20892-1201, USA. Mark_Dudley@nih.gov
James C Yang
Richard Sherry
Marybeth S Hughes
Richard Royal
Udai Kammula
Paul F Robbins
JianPing Huang
Deborah E Citrin
Susan F Leitman
John Wunderlich
Nicholas P Restifo
Armen Thomasian
Stephanie G Downey
Franz O Smith
Jacob Klapper
Kathleen Morton
Carolyn Laurencot
Donald E White
Steven A Rosenberg
National Institutes of Health Clinical Center · USNational Cancer Institute · US

Funding

Adoptive Cell Transfer Immunotherapy of CancerZIABC010984 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ROSENBERG, STEVEN · 2009 to 2025
$56.8M
Building on the success of the adoptive immunotherapy of cancerZIABC010763 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ROSENBERG, STEVEN · 2009 to 2020
$25.0M
Surgery Branch Cell Prep CoreZICBC010905 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HALAS, HYUNMI · 2009 to 2025
$23.9M
Cell Production Facility CoreZICBC011020 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI DUDLEY, MARK · 2009 to 2013
$6.5M
THE IMMUNOTHERAPY OF ANIMAL AND HUMAN CANCERZ01SC003811 · SC · CLINICAL SCIENCES · PI ROSENBERG, STEVEN A · 1996 to 2007
$3.2M
Intramural NIH HHS Z01 SC003811
6 · The paper itself

Abstract

purposeThe two approved treatments for patients with metastatic melanoma, interleukin (IL)-2 and dacarbazine, mediate objective response rates of 12% to 15%. We previously reported that adoptive cell therapy (ACT) with autologous antitumor lymphocytes in lymphodepleted hosts mediated objective responses in 51% of 35 patients. Here, we update that study and evaluate the safety and efficacy of two increased-intensity myeloablative lymphodepleting regimens. PATIENTS AND

methodsWe performed two additional sequential trials of ACT with autologous tumor-infiltrating lymphocytes (TIL) in patients with metastatic melanoma. Increasing intensity of host preparative lymphodepletion consisting of cyclophosphamide and fludarabine with either 2 (25 patients) or 12 Gy (25 patients) of total-body irradiation (TBI) was administered before cell transfer. Objective response rates by Response Evaluation Criteria in Solid Tumors (RECIST) and survival were evaluated. Immunologic correlates of effective treatment were studied.

resultsAlthough nonmyeloablative chemotherapy alone showed an objective response rate of 49%, when 2 or 12 Gy of TBI was added, the response rates were 52% and 72% respectively. Responses were seen in all visceral sites including brain. There was one treatment-related death in the 93 patients. Host lymphodepletion was associated with increased serum levels of the lymphocyte homeostatic cytokines IL-7 and IL-15. Objective responses were correlated with the telomere length of the transferred cells.

conclusionHost lymphodepletion followed by autologous TIL transfer and IL-2 results in objective response rates of 50% to 70% in patients with metastatic melanoma refractory to standard therapies.

Indexed as

Adoptive TransferLymphocyte DepletionAdolescentAdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCells, CulturedChemotherapy, AdjuvantChildCyclophosphamideFemaleHumansInterleukin-15Interleukin-2Interleukin-7Antineoplastic AgentsCyclophosphamidefludarabineIL7 protein, humanInterleukin-15Interleukin-2Interleukin-7Myeloablative AgonistsVidarabine

Identifiers

PMID18809613
PMCPMC2652090
OpenAlexW2127734125

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.