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Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 75 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    5 amendments

    5 re-verifications since 2025-04-21, no change to tracked fields

    v71-v75

  2. Minor

    Study Identification, Study Status, Oversight, IPDSharing

    v70

  3. Minor

    Study Identification, Study Status, Oversight, IPDSharing

    v69

  4. Minor

    4 amendments

    4 re-verifications since 2022-08-18, no change to tracked fields

    v65-v68

  5. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Enrollment target: estimated 189 to confirmed 1230; Site details revised

    Study Status, Study Design, Contacts/Locationsv64

Show 38 earlier versions

  1. Minor

    Primary and study completion dates: Feb 2030 to Feb 28, 2030

    Start date: Feb 2006 to Feb 1, 2006

    Study Statusv63

  2. Minor

    Site contact updated

    Study Status, Contacts/Locationsv62

  3. Minor

    Study Status

    Re-verified, no change to tracked fields

    v61

  4. Notable

    Primary and study completion dates: Feb 2019 to Feb 2030

    Study Statusv60

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v59

  6. Notable

    Primary endpoints: 2 to 3

    Eligibility criteria expanded, about 1 word; Study description shortened, about 1,515 words; Study arms: 4 to 5

    Show what changed: Primary endpoints
    Overall response rate (ORR) of TIL generated with the TIL 3.0 pre-REP methodology in Cohort E
    Show what changed: Eligibility criteria
    [...] able to undergo contrast-enhanced MRI. (Cohort D) Exclusion Criteria: Has had prior systemic cancer cytotoxic chemotherapy withi [...] Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria:) Patients with rapidly advancing systemic disease, especiall [...]
    Show what changed: Study description
    Leptomeningeal Disease: (Cohort D): Study Visits: You are expected to stay in the Houston area for at least 21 days in order to take part in this study. During this study, you will have the following tests and procedures: You will have an MRI of the complete spine and brain within 1 week before star [...]

    Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibilityv58

  7. Minor

    2 amendments

    2 re-verifications since 2017-08-15, no change to tracked fields

    v56-v57

  8. Notable

    Primary endpoints revised (2)

    Completion date: Feb 2019; Eligibility criteria shortened, about 1 word; Collaborators: 3 to 4

    Show what changed: Primary endpoints
    Longitudinal Immune Response in Cohort D
    Show what changed: Eligibility criteria
    [...] able to undergo contrast-enhanced MRI. (Cohort D) Exclusion Criteria: Has had prior systemic cancer cytotoxic chemotherapy withi [...] Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria): Patients with rapidly advancing systemic disease, especiall [...]
    Show what changed: Collaborators
    Adelson Medical Research

    Study Status, Sponsor/Collaborators, Oversight, Arms and Interventions, Outcome Measures, Eligibilityv55

  9. Notable

    Primary completion date: Feb 2018 to Feb 2019

    Eligibility criteria expanded, about 2 words; Study description shortened, about 1,679 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: Patients must have metastatic melanoma, uveal melanoma or stage III in-transit or regional nodal disease. [...]
    Show what changed: Study description
    Leptomeningeal Disease: (Cohort D) This study uses a cell transfer therapy to treat patients with uveal or metastatic melanoma. Immune cells, also called T cells (TILs), can recognize and kill melanoma cells. A T-cell is a type of lymphocyte. Lymphocytes are a type of white blood cell that protect you from viral infections, help oth [...] : If you agree to take part in the treatment portion of this study, the T-cells will be injected directly into your spinal fluid using what is called an "Ommaya reservoir". This is an intraventricular catheter system that can be used to collect cerebrospinal fluid ( [...] [...]

    Study Status, Study Description, Eligibilityv54

  10. Minor

    Study Status

    Re-verified, no change to tracked fields

    v53

  11. Minor

    Study description expanded, about 6 words

    Show what changed: Study description
    Leptomeningeal Disease: (Cohort D) This study uses a cell transfer therapy to treat patients with uveal or metastatic melanoma. Immune cells, also called T cells (TILs [...] s study uses cell transfer therapies to treat patients with uveal or metastatic melanoma. Immune cells, also called T cells, can [...] s study uses cell transfer therapies to treat patients with uveal or metastatic melanoma. Immune cells, also called T cells, can [...]

    Study Status, Study Descriptionv52

  12. Minor

    Study title expanded, about 5 words

    Show what changed: Study title
    Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma

    Study Identification, Study Statusv51

  13. Minor

    Study Status

    Re-verified, no change to tracked fields

    v50

  14. Notable

    Primary completion date: Feb 2017 to Feb 2018

    Eligibility criteria shortened, about 89 words; Study description expanded, about 550 words

    Show what changed: Eligibility criteria
    [...] testing will be performed within 7 days prior to treatment. (Turnstile II) Clinical performance status of ECOG 0 - 2 at the time of che [...] gressive disease in response to B-RAF treatment (Cohort C). i. Patients with leptomeningealMRI diseaseevidence asof per MRILMD, with or without positiveevidence of malignant cells in CSF ("positive cytology"), (Cohortor D)ii. Patients with evidence of malignant cells in the CSF (positive cytology), with or without MRI findingsevidence (Cohortof D)LMD, or iii. Patients with surgically-proven LMD (leptomeningeal diseaseinvolvement buton nopathology review) +/- MR [...] [...]
    Show what changed: Study description
    Leptomeningeal Disease: (Cohort D) This study uses a cell transfer therapy to treat patients with metastatic melanoma. Immune cells, also called T cells (TILs), can recognize and kill melanoma cells. A T-cell is a type of lymphocyte. Lymphocytes are a type of white blood cell that protect you from v [...] ⇅ moved If you agree to take part in the treatment portion of this study, the T-cells will be injected directly into your spinal fluid using what is called an "Ommaya reservoir". This is an intraventricular catheter system that can be used to collect cerebrospinal fluid (CSF) or to deliver drugs (in this ca [...] [...]

    Study Identification, Study Status, Study Description, Eligibilityv49

  15. Minor

    Study Status

    Re-verified, no change to tracked fields

    v48

  16. Notable

    Primary endpoints: 1 to 2

    Enrollment target: 159 to 189; Interventions: Cyclophosphamide (Drug), Dendritic Cell Immunization (Biological), Fludarabine (Drug), Interleukin-2 (Biological), Mesna (Drug), T Cells… to Cyclophosphamide (Drug), Dendritic Cell Immunization (Biological), Fludarabine (Drug), Interleukin-2 (Biological), Intrathecal…; Eligibility criteria expanded, about 451 words; and 2 more

    Show all 6 changes in this update
    • Notable Primary endpoints: 1 to 2
      Show what changed
      Longitudinal Immune Response
    • Minor Enrollment target: 159 to 189
    • Minor Interventions: Cyclophosphamide (Drug), Dendritic Cell Immunization (Biological), Fludarabine (Drug), Interleukin-2 (Biological), Mesna (Drug), T Cells… to Cyclophosphamide (Drug), Dendritic Cell Immunization (Biological), Fludarabine (Drug), Interleukin-2 (Biological), Intrathecal…
    • Minor Eligibility criteria expanded, about 451 words
      Show what changed
      [...] l to 12 years. (Turnstile I) Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-2. (Turnstile I) Patients previously treated with immunot [...] throughout the study such as: condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide. Abstinence is an acceptable for [...] gressive disease in response to B-RAF treatment (Cohort C). Patients with leptomeningeal disease as per MRI with or without positive CSF cytology (Cohort D) Patients with positive cytology with or without MRI findings (Cohort D) Patients with surgically proven leptomeningeal disease but no evi [...] [...]
    • Minor Study description expanded, about 782 words
      Show what changed
      [...] cancer fighting lymphocytes (T-cells) that will be infused. IL-2You washave recentlyalready approvedtaken by the FDA for the treatment of metastatic melanoma. IL-2 is a hormone naturally foundpart in the bodytissue thatharvest boostsand thescreening immune system. A biopsy procedureportion of thethis tumor will be performedstudy. AThe whole or partgrowth of your tumor will be cut and removed using high enough pain medication. This biopsy is being done to help attempt to grow the T-cells necessary for theyour treatment. Your T-cells will be grown in thethis laboratorypart withof the helpstudy o [...] [...]
    • Minor Study arms: 3 to 4

    Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibilityv47

  17. Notable

    Trial status: Active, Not Recruiting to Recruiting

    Site details revised; Study arms: 2 to 3

    Study Status, Arms and Interventions, Contacts/Locationsv46

  18. Notable

    Primary completion date: Feb 2016 to Feb 2017

    Primary endpoint revised; Trial status: Recruiting to Active, Not Recruiting; Site details revised

    Show what changed: Primary endpoints
    ClinicalObjective Response (CROR)

    Study Status, Outcome Measures, Contacts/Locationsv45

  19. Minor

    Collaborators: 2 to 3

    Show what changed: Collaborators
    National Cancer Institute (NCI)

    Study Status, Sponsor/Collaboratorsv44

  20. Minor

    Study Status

    Re-verified, no change to tracked fields

    v43

  21. Minor

    Eligibility criteria expanded, about 10 words

    Study description expanded, about 25 words

    Show what changed: Eligibility criteria
    [...] l to 12 years. (Turnstile I) Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-2. (Turnstile I) Patients previously treated with immunot [...] throughout the study such as: condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide. Abstinence is an acceptable for [...] tion therapy as evidenced by lymphocyte counts (> 500/mm3), white blood cell count (WBC) (> 3,000/mm3) or absence of opportunistic infections. (Turn [...]
    Show what changed: Study description
    [...] ystem. It is made in the lab, but from a normal human gene. A computed tomography (CT) scan of the chest, abdomen (stomach area), and pelvis (waist area) will be done to measure the tumor(s). A PET/CT may also be used. A MRI/CT scan of the brain will also be performed. A biopsy procedure of the tumor will be performed. A whole o [...] itic cells. A stress cardiac test (stress thallium , stress multiple gated acquisition scan (MUGA), dobutamine echocardiogram) within 6 months of lymphodepletion to rule out cardiac ischemia. AYou pulmonarywill have a lung function tests, (FEV1 > 65% or FVC >65% of pred [...] [...]

    Study Status, Study Description, Eligibility, Referencesv42

  22. Minor

    Study Status

    Re-verified, no change to tracked fields

    v41

  23. Notable

    Primary completion date: Feb 2015 to Feb 2016

    Eligibility criteria expanded, about 9 words; Study description expanded, about 118 words; Collaborators: 1 to 2

    Show what changed: Eligibility criteria
    [...] ell Infusion-Inclusion Criteria) Patients must be receiving Vemurafeniba B-RAF inhibitor and failed to achieve PR or CR or have progressive disease in response to VemurafenibB-RAF treatment (Cohort C). Exclusion Criteria: Has had prior sys [...] depletion regimen (Cohort A and Cohort B). Is not receiving VemurafenibB-RAF treatment (Cohort C) (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria) Achieves PR or CR in response to VemurafenibB-RAF treatment (Cohort C). Women who are pregnant or nursing wil [...] onal steroids in the past 2 weeks prior to lymphodepletion. Exception: Patients on physiolo [...] [...]
    Show what changed: Study description
    [...] g this time period. You will either receive T-cells alone or be assigned to a combination treatment group: If you HAVE NOT been treated in the past with a type of chemotherapy drug called a BRAF inhibitor, you will be randomized (as in the toss of a coin) to one of two three groups. Participants in onethe first group will receive chemotherapy and IL-2 plus T-cells. Part [...] y and IL-2 plus T-cells and the vaccine of dendritic cells. ParticipantsIf you HAVE been treated in the past with a BRAF inhibitor, you will be assigned to a third group, and will receive Vemurafeniba combination of chemotherapy [...]
    Show what changed: Collaborators
    ChironPrometheus CorporationLaboratories Key Biologics, LLC

    Study Identification, Study Status, Sponsor/Collaborators, Study Description, Eligibilityv40

  24. Minor

    Study Status

    Re-verified, no change to tracked fields

    v39

  25. Notable

    Trial status: Active, Not Recruiting to Recruiting

    Study description expanded, about 38 words; Site details revised

    Show what changed: Study description
    [...] ystem. It is made in the lab, but from a normal human gene. A computed tomography (CT) scan of the chest, abdomen (stomach area), and pelvis (waist area) will be done to measure the tumor(s). A PET/CT may also be used. A MRI/CT scan of the brain will also be performed. A biopsy procedure of the tumor will be performed. A whole o [...]

    Study Status, Study Description, Contacts/Locationsv38

  26. Minor

    Study description expanded, about 3 words

    Show what changed: Study description
    [...] chemotherapy starts and again on Days 7, 14, 21, 28, 35, 42, at Week 84 (+7 days), and at each followupfollow-up visit (+/- 7 days). At about 6 weeks (+ 7 days) and at 12 w [...]

    Study Status, Study Descriptionv37

  27. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv36

  28. Minor

    Study Status

    Re-verified, no change to tracked fields

    v35

  29. Notable

    Enrollment target: 98 to 159

    Primary completion date: Feb 2014 to Feb 2015; Eligibility criteria shortened, about 10 words; Study description expanded, about 20 words

    Show what changed: Eligibility criteria
    [...] ee no longer represents active disease will also be allowed.(Turnstile (Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria). Patien [...] ol for four months after receiving the preparative regimen. (Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria). Patients must have a documented negative pregnancy test (uri [...] on in the past 12 months and without sterilization surgery. (Turnstile II) Unless surgically sterile by bilateral tubal ligation or vas [...] ence is an acceptable form of birth control. (Turnstile II) Pregnancy testing will be performed within 7 days prior to treatment. Clinical [...] [...]
    Show what changed: Study description
    [...] ystem. It is made in the lab, but from a normal human gene. A computed tomography (CT) scan of the chest, abdomen (stomach area), and pelvis (waist area) will be done to measure the tumor(s). A PET/CT may also be used. A MRI/CT scan of the brain will also be performed. A biopsy procedure of the tumor will be performed. A whole o [...] e or be randomized (as in the toss of a coin) to one of two three groups. Participants in one group will receive chemotherapy and IL-2 plus T-cells. Participants in the othersecond group will receive chemotherapy and IL-2 plus T-cells and the vaccine of dendritic cells. [...] [...]

    Study Status, Study Description, Study Design, Eligibilityv34

  30. Minor

    Study Status

    Re-verified, no change to tracked fields

    v33

  31. Minor

    Eligibility criteria shortened, about 8 words

    Show what changed: Eligibility criteria
    [...] nstile II - Chemotherapy /Cell Infusion Exclusion Criteria) Patients who are pregnant or nursing. (Turnstile I) Has had prior systemic cancer therapy within the past four w [...]

    Study Status, Eligibilityv32

  32. Minor

    Study Status, Arms and Interventions

    Re-verified, no change to tracked fields

    v31

  33. Minor

    Study description expanded, about 38 words

    Show what changed: Study description
    [...] ystem. It is made in the lab, but from a normal human gene. A computed tomography (CT) scan of the chest, abdomen (stomach area), and pelvis (waist area) will be done to measure the tumor(s). A PET/CT may also be used. A MRI/CT scan of the brain will also be performed. A biopsy procedure of the tumor will be performed. A whole o [...]

    Study Status, Study Descriptionv30

  34. Minor

    Interventions: Cyclophosphamide (Drug), Dendritic Cell Immunization (Biological), Fludarabine (Drug), Interleukin-2 (Biological), T Cells (Biological) to Cyclophosphamide (Drug), Dendritic Cell Immunization (Biological), Fludarabine (Drug), Interleukin-2 (Biological), Mesna (Drug), T Cells…

    Study Status, Arms and Interventionsv29

  35. Minor

    Study Status

    Re-verified, no change to tracked fields

    v28

  36. Minor

    Eligibility criteria expanded, about 10 words

    Study description expanded, about 206 words

    Show what changed: Eligibility criteria
    [...] le I) Patients must receive an MRI/CT of the brain or PET/CT within 6 months of consenting. If new lesions are present, PI or his designee should make [...] uated by the PI or his designee as to suitable eligibility. (Turnstile I) Patients with a negative pregnancy test (urine or serum) must be documented at screening for women of childbearing potential. (Turnstile I) Patients must be HLA-A2 for cohort A. (Turnsti [...] f enrollment. (Turnstile I - Screening Exclusion Criteria). Has had prior B-RAF targeted therapy within 7 days prior to the start of lymphodepletion regimen. (Turnstile II - Chemotherapy /Ce [...] [...]
    Show what changed: Study description
    [...] ystem. It is made in the lab, but from a normal human gene. A biopsy procedure of the tumor will be performed. A whole or part of your tumor will be cut and removed using high enough pain medication. This biopsy is being done to help attempt to grow the T-cells necessary for the treatment. Your T-cells will be grown in the laboratory with the help of radiati [...] If eligibleresearchers are unable to grow enough cells or if your tumor does not have enough of the necessary components, you will not continue on study and other treatment options will be discussed with you. If the growth of these cells is [...] [...]

    Study Status, Study Description, Eligibilityv27

  37. Minor

    Study Status

    Re-verified, no change to tracked fields

    v26

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Objectives: The primary objective will be to determine whether patients receiving the combination of dendritic cells and high dose IL-2 (Cohort A) have sustained persistence of infused T cells compared to patients treated with T cells and high dose IL-2 alone. Secondary endpoints will include evaluations for tumor response and studies to determine whether dendritic cells enhance the infused T cells in anti-tumor activity and their ability to migrate to the tumor site. In addition, we will evaluate the characteristics of the infused T cells that correspond with effectiveness in vivo. Additionally, secondary objectives will include correlation of clinical parameters with survival (overall survival and progression-free survival) for all cohorts. COHORT C In a separate cohort (Cohort C) the primary endpoint will be the overall response rate of TIL treatment for patients who have not achieved PR or CR or have progressive disease from treatment of the BRAF inhibitor alone. COHORT D The primary objective of Cohort D is to confirm the safety of adoptively transferred, TIL into the CSF. The secondary objective is the evaluation of clinical imaging and CSF response. Correlative objectives will assess if the intrathecally-infused T cells persist in the CSF, assess circulating tumor cells in the CSF, and assess various cytokine and other analyses,as feasible. COHORT E The primary objective of Cohort E is to determine the overall response rate of TIL treatment with cells grown by the TIL 3.0 pre-REP (Turnstile 1) phase of cellular growth.
Trial Details
NCT Number NCT00338377
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Prometheus Laboratories, Key Biologics, LLC, National Cancer Institute (NCI), Adelson Medical Research
Conditions Melanoma
Enrollment 1,230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov