Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Vasodilator Agents

Urological Agents

Dermatologic Agents

Anticoagulants

Other Dietary Supplements

Cytarabine

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Azacitidine

Decitabine

Melphalan

Nivolumab

Sildenafil Citrate

Tretinoin

Citric Acid

Sodium Citrate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antimetabolites

Antiviral Agents

Enzyme Inhibitors

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Keratolytic Agents

Citrate

Nivolumab 1 mg/kg days 1,15 iv q28days Fludarabine 25 mg/m2 days 1-3 iv q28days Cyclophosphamide 300 mg/m2 days 1-3 iv q28days

Nivolumab 1 mg/kg days 1,15 iv q28days Cytarabine 10 mg/m2 bid days 1-10 sc q28days All-trans retinoic acid (ATRA) 45 mg/m2 po qd

Nivolumab 1 mg/kg days 1,15 iv q28days Cytarabine 10 mg/m2 bid days 1-10 sc q28days Sildenafil 20 mg tid

Nivolumab 1 mg/kg days 1,15 iv q28days Melphalan 2 mg qd days 1-10 q28days

Nivolumab 1 mg/kg days 1,15 iv q28days 5-azacitidine 75 mg/m2 days 1-7 q28days

1 mg/kg by vein on Days 1 and 15 of a 28 day cycle

75 mg/m2 subcutaneously on Days 1-7 of a 28 day cycle

25 mg/m2 by vein on Days 1, 2 and 3 of a 28 day cycle. Dose reduction to 15 mg/m2 is permitted in cases of grade 4 hematological toxicity after first cycle.

300 mg/m2 by vein on Days 1, 2 and 3 of a 28 day cycle.

10 mg/m2 subcutaneously two times a day on Days 1-10 of a 28 day cycle

45 mg/m2 per os daily during the whole course of treatment

all trans retinoic acid

20 mg per os three times a day during the whole course of treatment

Sildenafil

2 mg per os daily during the whole course of treatment

There is evidence of involvement of checkpoint pathways, including PD-1, in the pathogenesis and resistance of myelodysplastic syndrome (MDS). However monotherapy with checkpoint inhibitors was ineffective in a number of studies, indicating the presence of several mechanisms of resistance. This pilot study evaluates the safety and preliminary efficacy of nivolumab combination with currently existing treatments in MDS patients who failed at least one line of therapy. The study evaluates if there is a combination which induces objective responses.

Nivolumab With Chemotherapy in Refractory MDS

Pilot Open-label Trial of Nivolumab Combined With Chemotherapy in Refractory Myelodysplastic Syndromes.

Overall response rate (ORR) defined as complete response plus partial response (CR + PR) and hematological improvement (HI). MDS International Working Group criteria will be used to assess response.

Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).

Incidence of severe bacterial, fungal and viral infections incidence based on laboratory confirmation and attending physician assessment

St. Petersburg State Pavlov Medical University

Vice-director for science, R.M. Gorbacheva memorial institute

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Analgesics

Muromonab-CD3

Interleukin-2

Mesna

Analgesics, Non-Narcotic

IL-2 (interleukin-2)

OKT3

James Yang, M.D.

Background:

* Some patients with advanced kidney cancer have immune cells that can recognize and kill their cancer, but the cells are not active enough or numerous enough to accomplish this on their own.
* In recent studies of patients with advanced melanoma, some patients given special tumor-fighting cells (cells taken from the patient's tumor cells and grown in the laboratory) showed some anti-tumor response.

Objectives:

-To determine whether special tumor-fighting cells taken from the patient's blood or tumor and grown in the laboratory can cause tumors in patients with kidney cancer to shrink when they are given back to the patient along with interleukin-2.

Eligibility: Patients 18 years of age or older with advanced kidney cancer.

Design:

* Up to 29 patients will be treated in this study.
* Patients undergo tumor biopsy to collect tumor cells for creating special tumor-fighting cells for later infusion.
* Patients undergo apheresis to collect stem cells for later re-infusion. For apheresis, whole blood is collected through a needle in an arm vein and circulated through a cell-separating machine where the stem cells are extracted. The rest of the blood is returned through the same needle or a needle in the other arm.
* Before receiving the treated white cells, patients are given two drugs to suppress the immune system so the treated cells can work without interference from immune system cells. They are given cyclophosphamide over 2 days through a catheter (plastic tube inserted into a vein in the arm or neck) and fludarabine through the catheter over 15-30 minutes for the next 5 days.
* The day after the last dose of fludarabine, the tumor-fighting cells are infused through a vein over 10-20 minutes.
* Following the cell infusion, patients start treatment with high-dose interleukin-2 every 8 hours for a maximum of 12 doses.
* Patients are evaluated with x-ray studies about 1 month after receiving the cells and interleukin 2 (IL-2) to look for tumor response to treatment. Those who show significant improvement continue to receive treatment until the treated cells are used up or the patient no longer benefits or develops unacceptable side effects.

Background:

One area of therapeutic advancement in immunotherapy has been to identify autologous tumor-reactive T-cells and expand them in vitro, and administer them in adoptive transfer back to patients. These T-cells have been obtained either from tumor infiltrating lymphocytes (TIL) which appear enriched for tumor-reactive T-cells or by in vitro stimulation of peripheral blood T-cells from cancer patients. Recent success in patients with melanoma has in large part been due to a T-cell expansion protocol described by Riddell et al. using anti-CD3 (cluster of differentiation 3) and irradiated allogeneic feeder cells and the use of conditioning chemotherapy prior to cell transfer. This current study uses the results of these Surgery Branch adoptive cell therapy trials to study their potential in patients with metastatic renal cell cancer.

Objectives:

The primary objective will be to determine whether adoptive lymphocyte transfer in conjunction with preparative lympho-depletion chemotherapy and interleukin-2 (IL-2) may result in clinical tumor regression in patients with metastatic renal cancer.

Eligibility:

Patients with metastatic renal cell cancer who have failed conventional therapy with interleukin-2, from whom tumor-reactive lymphocytes (from either peripheral blood, lymph nodes or tumor-infiltrating lymphocytes) can be obtained and expanded in vitro.

Patients must meet specific safety laboratory criteria, be able to tolerate interleukin 2 (IL-2), and have no concurrent major medical illnesses or symptomatic brain metastases.

Design:

All patients will receive a non-myeloablative lymphocyte depleting preparative regimen of cyclophosphamide (60 mg/kg/day intravenous (IV)) on days -7 and -6 and fludarabine (25 mg/m\^2/day intravenous (IV)) on days -5 through -1. On day 0 patients will receive an infusion of their own tumor-reactive T cells grown in vitro (greater than or equal to 5x10\^8 cells for a cycle) and then begin high-dose IL-2 (720,000 IU/kg intravenous (IV) every 8 hours for up to 15 doses).

Clinical and Immunologic response will be evaluated about 3 to 5 weeks after the treatment regimen.

This trial will be conducted as a phase II trial using a two-stage MinMax design which will try to determine whether intravenous (IV) cell administration can produce a modest response rate targeted to be greater than or equal to 35 % (p1=0.35) as opposed to an undesirably low response rate of less than 15% (p0=0.15). If at least 3 patients of 15 have an objective response (partial response (PR) or complete response (CR)) accrual will proceed to 28 patients, with a projected accrual over three years.

Cultured White Cells Plus Interleukin-2 to Treat Advanced Kidney Cancer

Phase II Study in Metastatic Renal Cell Cancer Using Cultured, Tumor-Reactive Lymphocytes and Interleukin-2

National Cancer Institute (NCI)

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Aldesleukin

Anti-HIV Agents

Anti-Retroviral Agents

Day -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.

Surgery to remove a tumor for growth of TIL

Surgery

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

Administration of Lymphodepletion

Adoptive Cell Transfer

Beginning approximately 12 - 16 hours after cell infusion.

High Dose IL-2

Amod Sarnaik, M.D.

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.

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.

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

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.

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.

H. Lee Moffitt Cancer Center and Research Institute

Day -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.

Surgery: Surgery to remove a tumor for growth of TIL

Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo

Adoptive Cell Transfer: T-cell infusion

High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion.

TIL With High Dose IL-2

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

All 19 participants accrued are listed for baseline, Primary Outcome Measure and Adverse Events. All 13 participants who completed treatment are listed for analysis of Secondary Outcome Measure.

Participants with fragments cultured

Participants with fragments grown

Participants with fragments tested

Participants with IFN-γ positive fragments

Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth

Partial Response (PR)

Complete Response (CR)

Complete Response (PR + CR)

Number of Participants With Objective Response (OR)

Overall Study

Antibodies

Immunomodulating Agents

Immunoglobulins

Vemurafenib

Protein Kinase Inhibitors

Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).

A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.

High Dose Interleukin-2 (IL-2)

Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).

ACT with TIL Infusion

Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.

The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion.

Lymphodepletion

The purpose of this study is to find out more about the effects of an investigational combination of medicines, which includes special immune cells (T-cells).

A T-cell is a type of lymphocyte, or white blood cell. Lymphocytes are a kind of white blood cell that protect the body 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.

In this study, these special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the patient by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL). The investigators want to study the benefits and side effects of TIL when they are given with the following combination of drugs:

* Vemurafenib - a type of drug used to slow the growth of certain types of cancer cells. This drug will be given for about three weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to two years.
* Fludarabine and cyclophosphamide - two types of chemotherapy drugs. These drugs will be used for what is called lymphodepletion. The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the patient's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins.
* Interleukin-2 (IL-2) - a drug used to help the body's response to treatment on the immune system. A high dose regimen of IL-2 will be given after they receive the infusion of the T-cells.

The use of TIL is investigational, meaning it has not been approved by the U.S. Food and Drug Administration (FDA). Vemurafenib and IL-2 have been approved by the FDA for the treatment of metastatic melanoma and melanoma that cannot be surgically removed. The chemotherapy drugs fludarabine and cyclophosphamide, used for lymphodepletion, have been approved by the FDA, but not for the treatment of metastatic melanoma.

The combination of vemurafenib followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2 is investigational, and has not been proven to help treat melanoma. This combination is not FDA approved; however, the FDA is allowing its use in this study.

Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma

A Phase II Clinical Trial of Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Patients With Metastatic Melanoma

Overall response (OR) is defined as the patient being alive at month 12, and tumor size evaluated at screening and at month 12 using the RECIST 1.1 criteria to be a complete response (CR) or partial response (PR). Evaluations will be made by CT scan approximately 12 months from the date of tumor harvest, and by clinical evaluation during the first 12 months

The percentage of participants who drop out due to progression between the time of harvest and TIL transfer (i.e., the "drop-out rate").

Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Confidence intervals for the median and survival rates at different time points will be constructed if needed and appropriate. This secondary endpoint will be reported descriptively.

Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).

High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.

ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).

Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.

Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion.

Combination Therapy

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Percentage of Participants With Overall Response (OR)

Percentage of Participant Drop Out Rate

Number of Participants With Progression Free Survival (PFS)

Vaccines

Protective Agents

Cyclophosphamide 60 mg/kg/d by vein (IV) over 2 hours Days -7 and -6 (with Mesna) and Fludarabine 25 mg/m\^2 IV daily Days -5 to -1 before T cell infusion. On Day 0, up to 1.5 x 10\^11 T cells IV infusion over 30-60 minutes. Interleukin-2 12-16 hours after T cell infusion at standard dose of 720,000 IU/kg as intravenous bolus over 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26.

Group A has been closed to new patient entry as of January 14, 2016.

Chemotherapy and IL-2 plus T-cells and the vaccine of dendritic cells received by vein (IV) about 4 hours after T-cells and again on Day 21 (+/- 7 days). Cyclophosphamide 60 mg/kg/d IV over 2 hours Days -7 and -6 (with Mesna) and Fludarabine 25 mg/m\^2 IV daily Days -5 to -1 before T cell infusion. On Day 0, up to 1.5 x 10\^11 T cells IV infusion over 30-60 minutes. Interleukin-2 12-16 hours after T cell infusion at standard dose of 720,000 IU/kg as intravenous bolus over 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26.

T-cells: 5.0x109 TIL administered on Day 1 and 10x109 TIL on Day 15.

IL-2: 1.2 MIU of IL- 2 on Days 2, 4, 9, 11, 16 and 18 as tolerated. After this period, patient receives twice weekly IL-2 that will be gradually changed to weekly IL-2. After 4-6 weeks, patients switched to IL-2.

1x10\^7 to 2.5x10\^8 MART-1 peptide-pulsed Dendritic Cells given by vein over 20-30 minutes approximately 4 hrs after receiving T cells.

Dendritic Cell Immunization

60 mg/kg/d by vein over 2 hours on Days -7 and -6 before T cell infusion

25 mg/m\^2 by vein daily over 30 minutes on Days -5 to -1 before T cell infusion.

On Days 0, up to 1.5 x 10\^11 T-cells by vein infusion over 30-60 minutes.

T-Cells

12-16 hours after completing the T cell infusion, all will receive high dose IL-2 on an inpatient basis at the standard dose of 720,000 IU/kg as an intravenous bolus over approximately a 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26 (+/- 7 days), as tolerated.

60 mg/kg with D5W or NS at 125 ml/hr infused intravenously over 24 hours on Day -7 and -6.

5.0x10\^9 T-cells administered on Day 1, and 10x10\^9 T-cells on Day 15. 1.2 MIU of IL- 2 on Day 2, 4, 9, 11, 16 and 18 as tolerated.

Intrathecal T-Cells

1.2 MIU of IL- 2 on Day 2, 4, 9, 11, 16 and 18 as tolerated. Then, patient receives twice weekly IL-2 that will be gradually changed to weekly IL-2. After 4-6 weeks patients switched to IL-2 maintenance.

Intrathecal Interleukin-2

Rodabe N. Amaria, MD

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.

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

Objective response (OR) defined as immune-related Best Overall Response (irBOR). irBOR is best confirmed immune-related response criteria (irRC) overall response over the study as a whole, recorded between the date of first dose until the last tumor assessment before subsequent therapy (except for local palliative radiotherapy for painful bone lesions) for the individual subjects in the study.

Longitudinal immune response defined as: Conversion of positive to negative cytology. Any perceptible improvement of the MRI findings confirmed by radiologist and/or the investigator confirmed by 2 successive MRIs 4 weeks apart. Any clinical improvement in terms of neurological symptoms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nivolumab With Chemotherapy in Refractory MDS	NCT03259516	Myelodysplastic...	Nivolumab Azacitidine Fludarabine Cyclophosphamid... Cytarabine all trans retin... Sildenafil Melphalan	18 Years - 80 Years	St. Petersburg State Pavlov Medical University
Nivolumab With Chemotherapy in Refractory MDS	NCT03259516	Myelodysplastic...	Nivolumab Azacitidine Fludarabine Cyclophosphamid... Cytarabine all trans retin... Sildenafil Melphalan	18 Years - 80 Years	St. Petersburg State Pavlov Medical University
Cultured White Cells Plus Interleukin-2 to Treat Advanced Kidney Cancer	NCT00091611	Kidney Neoplasm...	IL-2 (interleuk... OKT3 Cyclophosphamid... Fludarabine Mesna	18 Years -	National Institutes of Health Clinical Center (CC)
Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma	NCT01005745	Metastatic Mela...	Surgery Administration ... Adoptive Cell T... High Dose IL-2	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma	NCT01659151	Metastatic Mela...	High Dose Inter... ACT with TIL In... Vemurafenib Lymphodepletion	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma	NCT00338377	Melanoma	Dendritic Cell ... Cyclophosphamid... Fludarabine T-Cells Interleukin-2 Mesna Intrathecal T-C... Intrathecal Int...	12 Years -	M.D. Anderson Cancer Center
T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Melanoma	NCT01946373	Melanoma	Cyclophosphamid... Fludarabine T cells Interleukin-2 Dendritic cell ...	18 Years - 74 Years	Karolinska University Hospital
Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies	NCT06408194	Leukemia Acute Lymphobla...	CD22CART infusi... Tisagenlecleuce...	1 Year - 25 Years	Stanford University

Spots Global Cancer Trial Database for lymphodepletion