NCT01218867|TerminatedPhase 1ResultsDMCFDA Drug

Study Stopped

No objective responses were observed.

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

Phase I/II Study of Metastatic Cancer Using Lymphodepleting Conditioning Followed by Infusion of Anti-VEGFR2 Gene Engineered CD8+ Lymphocytes

National Cancer Institute (NCI)ClinicalTrials.gov

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2 other identifiers

11001311-C-0013

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredOct 2010

StartedNov 2010

CompletionDec 2015

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Nov 2010

Longer than P75 for phase_1

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.1 years study duration

First Submitted

Initial submission to the registry

October 8, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed

1 month until next milestone

Study Start

First participant enrolled

November 10, 2010

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2014

Completed

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2015

Completed

7 months until next milestone

Results Posted

Study results publicly available

July 22, 2016

Completed

Last Updated

December 10, 2019

Status Verified

November 1, 2019

Enrollment Period

3.8 years

First QC Date

October 8, 2010

Results QC Date

April 15, 2016

Last Update Submit

November 18, 2019

Conditions

Metastatic Cancer Metastatic Melanoma Renal Cancer

Keywords

Clinical ResponseMetastatic CancerImmunotherapyAdoptive Cell TherapyMetastatic Melanoma

Outcome Measures

Primary Outcomes (1)

Number of Participants With a Response to Therapy
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.
5 years

Secondary Outcomes (2)

Number of Participants With Serious and Non-Serious Adverse Events
Date treatment consent signed to date off study, approximately, 33 months and 25 days
In Vivo Survival of Chimeric T Cell Receptor (CAR) Gene-engineered Cells
6 years