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NCT01740557

Genetically Modified Therapeutic Autologous Lymphocytes Followed by Aldesleukin in Treating Patients With Stage III or Metastatic Melanoma

Completed Phase 1, PHASE2 Results posted Last updated 8 October 2024
What this trial tests

Phase 1, PHASE2 trial testing Aldesleukin in Metastatic Melanoma in 10 participants. Completed in 21 April 2023.

Timeline
28 January 2015
Primary endpoint
21 April 2023
21 April 2023

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date28 January 2015
Primary completion21 April 2023
Estimated completion21 April 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Metastatic Melanoma or Stage III Cutaneous Melanoma AJCC v7. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Immune-Related Response Primary · Up to 1 year

Response will be defined as a 50% or greater decrease in the tumor's linear dimension post treatment, compared to baseline. Response will be evaluated by positron emission tomography or computed tomography imaging.

GroupValue95% CI
Treatment (Genetically Modified T-cells, High-dose Aldesleukin8
Number of Participants With Adverse Events Defined as Possible Grade 3 or Worse Toxicities Primary · Up to 8 weeks

Possible grade 3 or worse toxicities not normally associated with lymphodepletion and high dose IL-2 will be reported.

GroupValue95% CI
Treatment (Genetically Modified T-cells, High-dose Aldesleukin8

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline to 1 year follow-up. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Genetically Modified T-cells, High-dose Aldesleukin
Serious: 8/8 (100%)
Deaths: 1/8

Serious adverse events (4 terms)

ReactionSystemTreatment (Genetically Mod…
FeverGeneral disorders
Lung InfectionInfections and infestations
DeathGeneral disorders
SeizureNervous system disorders
Other adverse events (126 terms — click to expand)

ReactionSystemTreatment (Genetically Mod…
AlopeciaSkin and subcutaneous tissue disorders
Blood bilirubin increasedBlood and lymphatic system disorders
ChillsGeneral disorders
Neutrophil count decreasedInvestigations
Platelet count decreasedInvestigations
Activated partial thromboplastin time prolongedInvestigations
AnemiaBlood and lymphatic system disorders
AnorexiaMetabolism and nutrition disorders
FatigueBlood and lymphatic system disorders
Aspartate aminotransferase increasedInvestigations
HypoalbuminemiaMetabolism and nutrition disorders
INR IncreasedInvestigations
NauseaGastrointestinal disorders
PruritusSkin and subcutaneous tissue disorders
Alkaline phosphatase increasedInvestigations
ConstipationGastrointestinal disorders
Creatinine increasedInvestigations
DiarrheaGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
HypercalcemiaMetabolism and nutrition disorders
HypocalcemiaMetabolism and nutrition disorders
HypomagnesemiaMetabolism and nutrition disorders
Lymphocyte count decreasedInvestigations
Sinus tachycardiaCardiac disorders
AnxietyPsychiatric disorders
CoughRespiratory, thoracic and mediastinal disorders
Dry skinSkin and subcutaneous tissue disorders
Edema LimbsGeneral disorders
FeverGeneral disorders
Febrile neutropeniaBlood and lymphatic system disorders
Generalized muscle weaknessGeneral disorders
HyperglycemiaMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders
HypotensionVascular disorders
PainGeneral disorders
VomitingGastrointestinal disorders
Weight gainInvestigations
Weight lossInvestigations
White blood cell decreasedInvestigations
DizzinessNervous system disorders

Most-reported serious reactions: Fever, Lung Infection, Death, Seizure.

Data from ClinicalTrials.gov NCT01740557 adverse events section.

Sponsor's own description

This phase I/II trial studies how well genetically modified therapeutic autologous lymphocytes (patient's own white blood cells) followed by aldesleukin work in treating patients with stage III melanoma or melanoma that has spread to other places in the body (metastatic). Placing chemokine (C-X-C motif) receptor 2 (CXCR2) and nerve growth factor receptor (NGFR) into lymphocytes (white blood cells) may help the body build an immune response to kill melanoma cells. Aldesleukin may enhance this effect by stimulating white blood cells to kill more melanoma cells. Giving genetically modified therapeutic autologous lymphocytes together with aldesleukin may be a better treatment for melanoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. CAR T Cell Therapy for Solid Tumors: Bright Future or Dark Reality?
    Wagner J, Wickman E, DeRenzo C, Gottschalk S. · · 2020 · cited 284× · PMID 32979309 · DOI 10.1016/j.ymthe.2020.09.015
  2. The Role of CXC Chemokine Receptors 1-4 on Immune Cells in the Tumor Microenvironment.
    Susek KH, Karvouni M, Alici E, Lundqvist A. · · 2018 · cited 177× · PMID 30319622 · DOI 10.3389/fimmu.2018.02159
  3. T cells armed with C-X-C chemokine receptor type 6 enhance adoptive cell therapy for pancreatic tumours.
    Lesch S, Blumenberg V, Stoiber S, Gottschlich A, et al · · 2021 · cited 150× · PMID 34083764 · DOI 10.1038/s41551-021-00737-6
  4. Adoptive transfer of tumor-infiltrating lymphocytes in melanoma: a viable treatment option.
    Rohaan MW, van den Berg JH, Kvistborg P, Haanen JBAG. · · 2018 · cited 147× · PMID 30285902 · DOI 10.1186/s40425-018-0391-1
  5. CXCR1 Expression to Improve Anti-Cancer Efficacy of Intravenously Injected CAR-NK Cells in Mice with Peritoneal Xenografts.
    Ng YY, Tay JCK, Wang S. · · 2020 · cited 133× · PMID 31970285 · DOI 10.1016/j.omto.2019.12.006
  6. Tumor Infiltrating Lymphocyte (TIL) Therapy for Solid Tumor Treatment: Progressions and Challenges.
    Zhao Y, Deng J, Rao S, Guo S, et al · · 2022 · cited 114× · PMID 36077696 · DOI 10.3390/cancers14174160
  7. Tumor-infiltrating lymphocytes for treatment of solid tumors: It takes two to tango?
    Kazemi MH, Sadri M, Najafi A, Rahimi A, et al · · 2022 · cited 113× · PMID 36389779 · DOI 10.3389/fimmu.2022.1018962
  8. Role of chemokine systems in cancer and inflammatory diseases.
    Li H, Wu M, Zhao X. · · 2022 · cited 85× · PMID 35702353 · DOI 10.1002/mco2.147

Verify or expand the search:

Other trials of Aldesleukin

Trials testing the same drug.

Other recruiting trials for Metastatic Melanoma

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

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