Trial record 3 of 1504 for:    EGFR

Treatment of Chemotherapy Refractory EGFR(Epidermal Growth Factor Receptor) Positive Advanced Solid Tumors (CART-EGFR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01869166
First received: June 1, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous T cells may make the body build immune response to kill cancer cells.

PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in treating patients with EGFR positive advanced solid tumors, such as lung cancer, colorectal cancer and ovary cancer.


Condition Intervention Phase
Advanced EGFR-positive Solid Tumors
Biological: CART-EGFR
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of Chimeric EGFR Antigen Receptor-modified T Cells in Chemotherapy Refractory Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Occurrence of study related adverse events [ Time Frame: Until week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anti-leukemia responses to CART-EGFR cell infusions [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • in vivo existence of CART-EGFR [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: May 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anti-tumor response of CART-EGFR Biological: CART-EGFR

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-EGFR vector (referred to as CART-EGFR cells).

II. Determine duration of in vivo survival of CART-EGFR cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-EGFR TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over time.

SECONDARY OBJECTIVES:

I. For patients with detectable disease, measure anti-tumor response due to CART-EGFR cell infusions.

II. Estimate relative trafficking of CART-EGFR cells in tumor bed.

III. Determine if cellular or humoral host immunity develops against the murine anti-EGFR, and assess correlation with loss of detectable CART-EGFR (loss of engraftment).

IV. Determine the relative subsets of CART-EGFR T cells (Tcm, Tem, and Treg).

OUTLINE: Patients are assigned to 1 group according to order of enrollment.

Patients receive anti-EGFR-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.

Estimate relative trafficking of CART-EGFR cells in peripheral blood.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chemotherapy refractory EGFR-positive non-small cell lung cancer, colorectal cancer with liver metastasis,and chemotherapy resistant or relapsed ovary cancer.
  2. Relapsed patients after anti-EGFR using antibody or kinase inhibitor therapy.
  3. Patients must be 18 years of age or older.
  4. Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2.
  5. Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:

    Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).

    Total bilirubin < 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).

  6. Seronegative for HIV antibody.
  7. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
  8. Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test.
  9. Patients must be willing to sign an informed consent.

Exclusion Criteria:

  1. Patients with life expectancy less than 12 months will be excluded.
  2. Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
  3. Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
  4. Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
  5. Pregnant and/or lactating women will be excluded.
  6. Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
  7. Patients with any type of primary immunodeficiencies will be excluded from the study.
  8. Patients requiring corticosteroids (other than inhaled) will be excluded.
  9. Patients with history of T cell tumors will be excluded.
  10. Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869166

Contacts
Contact: weidong han, Dr. 86-10-13651392893 hanwdrsw@sina.com
Contact: kaichao feng, Dr. 86-10-13811421950 timothyfkc@126.com

Locations
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: weidong han, Dr.    86-10-13651392893    hanwdrsw@sina.com   
Contact: Kaichao Feng, Dr.    86-10-13811421950    timothyfkc@126.com   
Principal Investigator: Yao Wang, Dr.         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Chair: weidong han, Dr. Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: Han weidong, Professor and Director, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01869166     History of Changes
Other Study ID Numbers: CHN-PLAGH-BT-007
Study First Received: June 1, 2013
Last Updated: June 1, 2013
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
chemotherapy and/or EGFR-antibody/kinase inhibitor therapy refractory solid tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 26, 2014