Back to resultsTreatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101 (TREAT-ME 1)
Primary Purpose
Advanced Gastrointestinal Cancer
Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
MSC_apceth_101
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Gastrointestinal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma.
- Premature or scheduled termination of standard therapy
- Progressive disease as clinically assessed by the investigator
- Max. tumour lesion ≤ 5 cm
- Adequate organ function
- Ability of patient to understand character and individual consequences of clinical trial
- Age ≥ 18 years
- Written informed consent must be available before any study specific procedure is performed
Exclusion Criteria:
- Patients with severe heart diseases
- Clinical significant ischemic disease during the last 4 weeks before Visit 1
- Severe lung disease
- Symptomatic peritoneal carcinomatosis
- Symptomatic pleural or pericardial effusion
- Serious uncontrolled acute infections less than 3 weeks before Visit 1
- Known dependency on alcohol or other drugs
- Patients requiring corticoids in doses above the Cushing threshold
- Known liver fibrosis or liver cirrhosis
- Any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator
- Female patient who is pregnant or breast feeding
- Participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first IMP dose
Sites / Locations
- University Hospital Munich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment arm
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability as indicated by Common Toxicity Criteria (CTC-AE) of the National Cancer Institute
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02008539
Brief Title
Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101
Acronym
TREAT-ME 1
Official Title
Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Enrollment terminated after 13 patients (14 planned); further patients did not meet eligibility criteria to receive autologous IMP
Study Start Date
October 2013 (Actual)
Primary Completion Date
September 7, 2016 (Actual)
Study Completion Date
September 7, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apceth GmbH & Co. KG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the safety and tolerability of MSC_apceth_101.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastrointestinal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MSC_apceth_101
Primary Outcome Measure Information:
Title
Safety and tolerability as indicated by Common Toxicity Criteria (CTC-AE) of the National Cancer Institute
Time Frame
day 56 (+/- 7) in patient group 1 and day 29 (+/-3) in patient group 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma.
Premature or scheduled termination of standard therapy
Progressive disease as clinically assessed by the investigator
Max. tumour lesion ≤ 5 cm
Adequate organ function
Ability of patient to understand character and individual consequences of clinical trial
Age ≥ 18 years
Written informed consent must be available before any study specific procedure is performed
Exclusion Criteria:
Patients with severe heart diseases
Clinical significant ischemic disease during the last 4 weeks before Visit 1
Severe lung disease
Symptomatic peritoneal carcinomatosis
Symptomatic pleural or pericardial effusion
Serious uncontrolled acute infections less than 3 weeks before Visit 1
Known dependency on alcohol or other drugs
Patients requiring corticoids in doses above the Cushing threshold
Known liver fibrosis or liver cirrhosis
Any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator
Female patient who is pregnant or breast feeding
Participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first IMP dose
Facility Information:
Facility Name
University Hospital Munich
City
Munich
ZIP/Postal Code
81377
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101
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