- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01525017
A Clinical Study to Evaluate Safety and Immunologic Response of COMBIG-DC, in Patients With Metastatic Kidney Cancer
October 9, 2015 updated by: Mendus
A Phase I Open-label Study to Evaluate Safety and Immunologic Response of COMBIG-DC Administered Intratumorally in Patients With Metastatic Renal Cell Carcinoma
The primary objective of this study is to answer the question "Is it possible to inject the Combig-DC vaccine in a renal tumour without getting unacceptable side effects"?
Patients newly diagnosed with metastatic renal cell carcinoma will get Combig-DC vaccinations at two occasions in a two weeks period (day 1 and day 14).
After another two weeks the kidney will be eliminated.
Adverse events will be registered, as well as changes in vital signs(heart rate, blood pressure and body temperature) and lab parameters.
Immunologic response will be evaluated by measuring immunologic markers in blood and tumour tissue, and measuring the size of the metastases three months after nephrectomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Uppsala, Sweden, 751 85
- Dept of Oncology, University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be informed of the nature of the study and have provided written informed consent
- At least 18 years of age.
- Diagnosis of renal cell carcinoma with at least one distant metastasis, and/or one distant lymph node metastasis.
- Tumor size (renal cell carcinoma; primary tumor) at least 4.0 cm in longest diameter as measured by CT. Distant metastasis at least 1 cm diameter as measured by CT or a distant lymph node metastasis at least 2,5 cm diameter as measured by CT. Clinical stage 'T1b or more; NX; M1'
Adequate hematological parameters, i.e:
B-Leukocyte count ≥ 4.5 x 109/L B-Platelet count ≥ 150 x109/L B-Haemoglobin ≥ 100 g/L
- Women of Childbearing Potential (WOCBP) should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period.
Exclusion Criteria:
- Performance status > ECOG 2 after optimization of analgesics
- Adequate coagulation parameters, i.e: P-Prothrombin complex (PK), P-APT time
- Ongoing treatment with systemic corticosteroids (inhaled, intranasal and local steroids accepted) within 28 days before first vaccination.
- Previously known or ongoing active autoimmune disease which requires treatment with systemic immunosuppressive agents. E.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, SLE, vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases.
- Patients with previous or ongoing skin malignancy (basal-cell carcinoma, squamous cell carcinoma, melanoma), other hematological or solid malignancy or blood dysfunctions.
- Ongoing infection that requires treatment with antibiotics.
- Known major reaction/adverse event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction)
- Known malignancy in CNS.
- Active or latent virus disease (HIV, HBV and HCV).
- Ongoing pregnancy or lactation. Females needs to have negative pregnancy test at screening visit.
- Life expectancy less than 3 months.
- Concomitant exposure to other investigational products.
- Any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Combig-DC Cancer Vaccine
Two vaccinations of Combig-DC (allogeneic dendritic cells) Cancer Vaccine given before nephrectomy.
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Cryopreserved dendritic cell suspension of 10 million cells per ml in heat-inactivated plasma, supplemented with 10% dimethyl sulfoxide (DMSO).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Registration of adverse events as a measure of safety and tolerability
Time Frame: 1 year 3 months (Feb 2012-May 2013)
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1 year 3 months (Feb 2012-May 2013)
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Changes in vital signs from baseline (heart rate, blood pressure, body temperature) as a measure of safety and tolerability
Time Frame: 1 year 3 months (Feb 2012 - May 2013)
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1 year 3 months (Feb 2012 - May 2013)
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Changes in lab parameters from baseline as a measure of safety and tolerability
Time Frame: 1 year 3 months (Feb 2012 - May 2013)
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1 year 3 months (Feb 2012 - May 2013)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunologic response in blood (immunologic panel) measured with ELISPOT.
Time Frame: 1 year 3 months (Feb 2012 - May 2013)
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Time for sampling: just before first injection and second injection, 2 weeks post second injection (in connection with the hospitalization for nephrectomy) and at 3 months post nephrectomy.
ELISPOT assessment will be made at time of nephrectomy (after the second vaccination) at earliest.
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1 year 3 months (Feb 2012 - May 2013)
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Examination of immunohistology parameters (macrophage marker, CD3, CD4, CD8, CD56) of the renal tumor post nephrectomy.
Time Frame: 1 year 3 months (Feb 2012 - May 2013)
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1 year 3 months (Feb 2012 - May 2013)
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CT-evaluation of the size of the metastasis(-es) 3 months post nephrectomy
Time Frame: 1 year 3 months (Feb 2012 - March 2013)
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1 year 3 months (Feb 2012 - March 2013)
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CT evaluation to evaluate number of metastases 3 months post nephrectomy.
Time Frame: 1 year 3 months (Feb 2012 - May 2013)
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1 year 3 months (Feb 2012 - May 2013)
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Changes in body weight 3 months post nephrectomy vs. baseline.
Time Frame: 1 year 3 months (Feb 2012 - May 2013)
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1 year 3 months (Feb 2012 - May 2013)
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Changes in WHO-ECOG 3 months post nephrectomy vs. baseline.
Time Frame: 1 year 3 months (Feb 2012 - may 2013)
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1 year 3 months (Feb 2012 - may 2013)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anna Laurell, MD, PhD, Dept of Oncology , Uppsala University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 20, 2012
First Submitted That Met QC Criteria
January 31, 2012
First Posted (Estimate)
February 2, 2012
Study Record Updates
Last Update Posted (Estimate)
October 12, 2015
Last Update Submitted That Met QC Criteria
October 9, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IM-101
- 2011-002039-25 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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