Efficacy Study of TKcell in Advanced Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by Binex.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Binex

ClinicalTrials.gov Identifier:

NCT00854971

First received: February 28, 2009

Last updated: May 15, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 28, 2009

Last Updated Date

May 15, 2009

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine response rate [ Time Frame: within study period ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00854971 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Determine safety of combination,time to treatment failure, overall survival time [ Time Frame: within study period ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy Study of TKcell in Advanced Colorectal Cancer

Official Title ^ICMJE

Evaluating the Safety and Efficacy of Combination Therapy With FOLFOX-4 and TKcell Therapy Versus FOLFOX-4 Alone in Patients With Recurrent, Unresectable and Advanced Colorectal Cancer

Brief Summary

The purpose of this study is to determine efficacy of NKCell in colorectal cancer

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Advanced Colorectal Cancer

Intervention ^ICMJE

Biological: TKCell

Biological/Vaccine: TKCell

Other Names:

TKCell
NKCell
FOLFOX-4

Study Arm (s)

No Intervention: control
Oxaliplatin infusion (85mg/m2) on days 1 and 15 (every 2 weeks) 5-FU bolus + infusions (400 mg/m2) on days 1, 2, 15 and 16 LV infusions (200 mg/m2) on days 1, 2, 15 and 16
Active Comparator: Active
FOLFOX-4 regimen + Infusion of TKCell(autologous activated lymphocyte) over 2x10^9 cells, IV route, 7 times

Intervention: Biological: TKCell

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Written informed consent.
Diagnosis of histologically confirmed adenocarcinoma of the colorectal
ECOG performance status of 0 - 2
At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥2cm in physical examination
Adequate liver, renal, bone marrow functions as evidence by the following;
Absolute neutrophil count > 1.5 x 109/L; platelets > 7.5 x 109/L; Bilirubin less than 2 mg/dL ASAT and/or ALAT < 5 UNL; serum creatinine ≤ 2 ULN
Minimum life expectancy of 12 weeks
Effective contraception for both male and female subjects if the risk of conception exists

Exclusion Criteria:

Brain metastasis and/or leptomeningeal disease (known or suspected)
Previous chemotherapy for gastric cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment.
Previous oxaliplatin-based chemotherapy
Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization and chemotherapy
HIV antibody (+), Chronic hepatitis
Uncontrolled infection
Concurrent or previous chronic systemic immune therapy, targeted therapy, hormonal therapy not indicated in the study protocol except for contraception
Clinically relevant coronary artery disease, history of myocardial infarction, high risk of uncontrolled arrhythmia
Known hypersensitivity reaction to any of the components of the treatment.
Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
Participation in another clinical study within the 30 days before randomization
Significant disease which, in the investigator's opinion, would exclude the subject from the study

Gender

Both

Ages

19 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00854971

Other Study ID Numbers ^ICMJE

BX-TK-002

Has Data Monitoring Committee

Responsible Party

Park, Eun-Jin / Research institute, CRM(clinical research manager)

Study Sponsor ^ICMJE

Binex

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Seok-Goo Cho, M.D, Ph.D

The Catholic Medical Center

Information Provided By

Binex

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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