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CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01218867
Recruitment Status : Terminated (No objective responses were observed.)
First Posted : October 11, 2010
Results First Posted : July 22, 2016
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Steven Rosenberg, M.D., National Cancer Institute (NCI)

Brief Summary:

Background:

The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients metastatic cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient s white blood cells with a retrovirus that has the gene for anti-vascular endothelial growth factor receptor (VEGFR2) incorporated in the retrovirus.

Objectives:

- To determine a safe number of these cells to infuse and to see the safety and effectiveness of cell therapy using anti-VEGFR2 gene modified tumor white blood cells to treat recurrent or relapsed cancer.

Eligibility:

- Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with metastatic cancer that has not responded to or has relapsed after standard treatment.

Design:

  • Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed
  • Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti-VEGFR2 cells. {Leukapheresis is a common procedure which removes only the white blood cells from the patient.}
  • Treatment: Once their cells have grown the patients will be admitted to the hospital for the conditioning chemotherapy, the anti-VEGFR2 cells and aldesleukin. They will stay in the hospital for about4 weeks for the treatment.
  • Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Metastatic Melanoma Renal Cancer Biological: Anti-VEGFR2 CAR CD8 plus PBL Drug: Cyclophosphamide Biological: Aldesleukin Drug: Fludarabine Phase 1 Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Metastatic Cancer Using Lymphodepleting Conditioning Followed by Infusion of Anti-VEGFR2 Gene Engineered CD8+ Lymphocytes
Actual Study Start Date : November 10, 2010
Actual Primary Completion Date : September 3, 2014
Actual Study Completion Date : December 15, 2015


Arm Intervention/treatment
Experimental: Cohort 1 (1x10(6) cells (high dose IL-2)
Patients will receive (1x10(6) cells plus high dose aldesleukin
Biological: Anti-VEGFR2 CAR CD8 plus PBL
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose (Arms 1-7) or low dose (Arms 8-11) aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Drug: Cyclophosphamide
Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose in 5% water (D5W) with mesna 15 mg/kg/day X 2 days over 1 hr
Other Name: Cytoxan

Biological: Aldesleukin
Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg (Arms 1-7) or 72,000 IU/kg (Arms 8-11) as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Other Name: Proleukin

Drug: Fludarabine
Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days
Other Name: Fludara

Experimental: Cohort 2 (3x10(6) cells (high dose IL-2)
Patients will receive (3x10(6) cells plus high dose aldesleukin
Biological: Anti-VEGFR2 CAR CD8 plus PBL
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose (Arms 1-7) or low dose (Arms 8-11) aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Drug: Cyclophosphamide
Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose in 5% water (D5W) with mesna 15 mg/kg/day X 2 days over 1 hr
Other Name: Cytoxan

Biological: Aldesleukin
Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg (Arms 1-7) or 72,000 IU/kg (Arms 8-11) as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Other Name: Proleukin

Drug: Fludarabine
Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days
Other Name: Fludara

Experimental: Cohort 3 (1x10(7) cells (high dose IL-2)
Patients will receive (1x10(7) cells plus high dose aldesleukin
Biological: Anti-VEGFR2 CAR CD8 plus PBL
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose (Arms 1-7) or low dose (Arms 8-11) aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Drug: Cyclophosphamide
Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose in 5% water (D5W) with mesna 15 mg/kg/day X 2 days over 1 hr
Other Name: Cytoxan

Biological: Aldesleukin
Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg (Arms 1-7) or 72,000 IU/kg (Arms 8-11) as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Other Name: Proleukin

Drug: Fludarabine
Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days
Other Name: Fludara

Experimental: Cohort 4 (3x10(7) cells (high dose IL-2)
Patients will receive (3x10(7) cells plus high dose aldesleukin
Biological: Anti-VEGFR2 CAR CD8 plus PBL
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose (Arms 1-7) or low dose (Arms 8-11) aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Drug: Cyclophosphamide
Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose in 5% water (D5W) with mesna 15 mg/kg/day X 2 days over 1 hr
Other Name: Cytoxan

Biological: Aldesleukin
Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg (Arms 1-7) or 72,000 IU/kg (Arms 8-11) as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Other Name: Proleukin

Drug: Fludarabine
Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days
Other Name: Fludara

Experimental: Cohort 5 (1x10(8) cells (high dose IL-2)
Patients will receive (1x10(8) cells plus high dose aldesleukin
Biological: Anti-VEGFR2 CAR CD8 plus PBL
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose (Arms 1-7) or low dose (Arms 8-11) aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Drug: Cyclophosphamide
Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose in 5% water (D5W) with mesna 15 mg/kg/day X 2 days over 1 hr
Other Name: Cytoxan

Biological: Aldesleukin
Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg (Arms 1-7) or 72,000 IU/kg (Arms 8-11) as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Other Name: Proleukin

Drug: Fludarabine
Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days
Other Name: Fludara

Experimental: Cohort 6 (3x10(8) cells (high dose IL-2)
Patients will receive (3x10(8) cells plus high dose aldesleukin
Biological: Anti-VEGFR2 CAR CD8 plus PBL
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose (Arms 1-7) or low dose (Arms 8-11) aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Drug: Cyclophosphamide
Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose in 5% water (D5W) with mesna 15 mg/kg/day X 2 days over 1 hr
Other Name: Cytoxan

Biological: Aldesleukin
Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg (Arms 1-7) or 72,000 IU/kg (Arms 8-11) as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Other Name: Proleukin

Drug: Fludarabine
Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days
Other Name: Fludara

Experimental: Cohort 7 (1x10(9) cells (high dose IL-2)
Patients will receive (1x10(9) cells plus high dose aldesleukin
Biological: Anti-VEGFR2 CAR CD8 plus PBL
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose (Arms 1-7) or low dose (Arms 8-11) aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Drug: Cyclophosphamide
Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose in 5% water (D5W) with mesna 15 mg/kg/day X 2 days over 1 hr
Other Name: Cytoxan

Biological: Aldesleukin
Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg (Arms 1-7) or 72,000 IU/kg (Arms 8-11) as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Other Name: Proleukin

Drug: Fludarabine
Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days
Other Name: Fludara

Experimental: Cohort 8 (1x10(9) cells (low dose IL-2)
Patients will receive (1x10(9) cells plus low dose aldesleukin
Biological: Anti-VEGFR2 CAR CD8 plus PBL
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose (Arms 1-7) or low dose (Arms 8-11) aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Drug: Cyclophosphamide
Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose in 5% water (D5W) with mesna 15 mg/kg/day X 2 days over 1 hr
Other Name: Cytoxan

Biological: Aldesleukin
Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg (Arms 1-7) or 72,000 IU/kg (Arms 8-11) as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Other Name: Proleukin

Drug: Fludarabine
Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days
Other Name: Fludara

Experimental: Cohort 9 (3x10(9) cells (low dose IL-2)
Patients will receive (3x10(9) cells plus low dose aldesleukin
Biological: Anti-VEGFR2 CAR CD8 plus PBL
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose (Arms 1-7) or low dose (Arms 8-11) aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Drug: Cyclophosphamide
Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose in 5% water (D5W) with mesna 15 mg/kg/day X 2 days over 1 hr
Other Name: Cytoxan

Biological: Aldesleukin
Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg (Arms 1-7) or 72,000 IU/kg (Arms 8-11) as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Other Name: Proleukin

Drug: Fludarabine
Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days
Other Name: Fludara

Experimental: Cohort10(1x10(10) cells (low dose IL-2)
Patients will receive (1x10(10) cells plus low dose aldesleukin
Biological: Anti-VEGFR2 CAR CD8 plus PBL
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose (Arms 1-7) or low dose (Arms 8-11) aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Drug: Cyclophosphamide
Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose in 5% water (D5W) with mesna 15 mg/kg/day X 2 days over 1 hr
Other Name: Cytoxan

Biological: Aldesleukin
Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg (Arms 1-7) or 72,000 IU/kg (Arms 8-11) as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Other Name: Proleukin

Drug: Fludarabine
Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days
Other Name: Fludara

Experimental: Cohort11(3x10(10) cells (low dose IL-2)
Patients will receive (3x10(10) cells plus low dose aldesleukin
Biological: Anti-VEGFR2 CAR CD8 plus PBL
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose (Arms 1-7) or low dose (Arms 8-11) aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Drug: Cyclophosphamide
Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose in 5% water (D5W) with mesna 15 mg/kg/day X 2 days over 1 hr
Other Name: Cytoxan

Biological: Aldesleukin
Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg (Arms 1-7) or 72,000 IU/kg (Arms 8-11) as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Other Name: Proleukin

Drug: Fludarabine
Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days
Other Name: Fludara




Primary Outcome Measures :
  1. Number of Participants With a Response to Therapy [ Time Frame: 5 years ]
    Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.


Secondary Outcome Measures :
  1. Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: Date treatment consent signed to date off study, approximately, 33 months and 25 days ]
    Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

  2. In Vivo Survival of Chimeric T Cell Receptor (CAR) Gene-engineered Cells [ Time Frame: 6 years ]
    Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR) will be used to augment polymerase chain reaction (PCR)-based analysis. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Metastatic cancer with evaluable disease.
    2. Patients must have previously received at least one systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred.
    3. Greater than or equal to 18 years of age and less than or equal to 70 years of age.
    4. Willing to sign a durable power of attorney
    5. Able to understand and sign the Informed Consent Document
    6. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
    7. Life expectancy of greater than three months.
    8. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment.
    9. Serology:

      1. Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)
      2. Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative.
    10. Hematology:

      1. Absolute neutrophil count greater than 1000/mm(3) without the support of filgrastim.
      2. White blood cell (WBC) (> 3000/mm(3)).
      3. Platelet count greater than 100,000/mm(3).
      4. Hemoglobin greater than 8.0 g/dl.
    11. Chemistry:

      1. Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 2.5 times the upper limit of normal.
      2. Serum creatinine less than or equal to 1.6 mg/dl.
      3. Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilberts Syndrome who must have a total bilirubin less than 3.0 mg/dl.
    12. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).
    13. More than 4 weeks must have elapsed since an surgical procedure at the time the patient receives the preparative regimen due to the inhibition of wound healing observed with vascular endothelial growth factor receptor (VEGFR) targeting angiogenesis inhibitors.

EXCLUSION CRITERIA:

  1. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
  2. Patients with known brain metastases.
  3. Patients receiving full dose anticoagulative therapy.
  4. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
  5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
  6. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
  7. Patients with diabetic retinopathy.
  8. Concurrent Systemic steroid therapy.
  9. History of severe immediate hypersensitivity reaction to any of the agents used in this study.
  10. History of coronary revascularization or ischemic symptoms.
  11. In patients

Documented forced expiratory volume 1 (FEV1) less than or equal to 45% predicted tested in patients with:

  1. History of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block.
  2. Age greater than or equal to 60 years old.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218867


Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Steven A Rosenberg, M.D. National Cancer Institute (NCI)
  Study Documents (Full-Text)

Documents provided by Steven Rosenberg, M.D., National Cancer Institute (NCI):
Informed Consent Form  [PDF] July 15, 2015


Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Steven Rosenberg, M.D., Principal Investigator, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01218867    
Other Study ID Numbers: 110013
11-C-0013
First Posted: October 11, 2010    Key Record Dates
Results First Posted: July 22, 2016
Last Update Posted: December 10, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Steven Rosenberg, M.D., National Cancer Institute (NCI):
Clinical Response
Metastatic Cancer
Immunotherapy
Adoptive Cell Therapy
Metastatic Melanoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neoplasm Metastasis
Neoplasms, Second Primary
Kidney Neoplasms
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Aldesleukin
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Interleukin-2
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action