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Advanced Colorectal CancerPhase 1/2NCT00854971

Efficacy Study of TKcell in Advanced Colorectal Cancer

A Phase 1/2 study testing TKCell in people with Advanced Colorectal Cancer, run by Binex at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Advanced Colorectal Cancer
What is being tested?
TKCell
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteSouth Korea
Study dates
Jan 2009to Jan 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • The Catholic University of Korea

    Seoul, Banpo-dong, 137-701

Other trials in South Korea

About this study

Official title: 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

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

Being tested
TKCell
Keywords
NKCell, FOLFOX-4, advanced or unresectable colorectal cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TKCellBiological

    Also called NKCell, FOLFOX-4

    Biological/Vaccine: TKCell

Study groups in NCT00854971
Study groupRoleWhat they receive
controlNo interventionOxaliplatin 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
ActiveActive comparatorFOLFOX-4 regimen + Infusion of TKCell(autologous activated lymphocyte) over 2x10^9 cells, IV route, 7 times
Receives: Biological: TKCell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine response rate

    Measured: within study period

Secondary outcomes (1)

  1. Determine safety of combination,time to treatment failure, overall survival time

    Measured: within study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionJan 2010 (estimated)
  4. Study completionJan 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00854971
Sponsor's protocol ID
BX-TK-002
Status last verified
Mar 2009
First submitted
28 Feb 2009
Last updated
18 May 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TKCell in people with Advanced Colorectal Cancer, run by Binex at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine response rate (time frame: within study period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00854971.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2009.

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