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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Sweden
      • Uppsala, Sweden, 751 85
        • Dept of Oncology, University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Be informed of the nature of the study and have provided written informed consent
  2. At least 18 years of age.
  3. Diagnosis of renal cell carcinoma with at least one distant metastasis, and/or one distant lymph node metastasis.
  4. 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'

  5. Adequate hematological parameters, i.e:

    B-Leukocyte count ≥ 4.5 x 109/L B-Platelet count ≥ 150 x109/L B-Haemoglobin ≥ 100 g/L

  6. Women of Childbearing Potential (WOCBP) should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period.

Exclusion Criteria:

  1. Performance status > ECOG 2 after optimization of analgesics
  2. Adequate coagulation parameters, i.e: P-Prothrombin complex (PK), P-APT time
  3. Ongoing treatment with systemic corticosteroids (inhaled, intranasal and local steroids accepted) within 28 days before first vaccination.
  4. 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.
  5. Patients with previous or ongoing skin malignancy (basal-cell carcinoma, squamous cell carcinoma, melanoma), other hematological or solid malignancy or blood dysfunctions.
  6. Ongoing infection that requires treatment with antibiotics.
  7. Known major reaction/adverse event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction)
  8. Known malignancy in CNS.
  9. Active or latent virus disease (HIV, HBV and HCV).
  10. Ongoing pregnancy or lactation. Females needs to have negative pregnancy test at screening visit.
  11. Life expectancy less than 3 months.
  12. Concomitant exposure to other investigational products.
  13. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Combig-DC Cancer Vaccine
Two vaccinations of Combig-DC (allogeneic dendritic cells) Cancer Vaccine given before nephrectomy.
Biological: Combig-DC (allogeneic dendritic cells) Cancer Vaccine
Cryopreserved dendritic cell suspension of 10 million cells per ml in heat-inactivated plasma, supplemented with 10% dimethyl sulfoxide (DMSO).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
1 year 3 months (Feb 2012-May 2013)
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)
1 year 3 months (Feb 2012 - May 2013)
Changes in lab parameters from baseline as a measure of safety and tolerability
Time Frame: 1 year 3 months (Feb 2012 - May 2013)
1 year 3 months (Feb 2012 - May 2013)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
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.
1 year 3 months (Feb 2012 - May 2013)
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)
1 year 3 months (Feb 2012 - May 2013)
CT-evaluation of the size of the metastasis(-es) 3 months post nephrectomy
Time Frame: 1 year 3 months (Feb 2012 - March 2013)
1 year 3 months (Feb 2012 - March 2013)
CT evaluation to evaluate number of metastases 3 months post nephrectomy.
Time Frame: 1 year 3 months (Feb 2012 - May 2013)
1 year 3 months (Feb 2012 - May 2013)
Changes in body weight 3 months post nephrectomy vs. baseline.
Time Frame: 1 year 3 months (Feb 2012 - May 2013)
1 year 3 months (Feb 2012 - May 2013)
Changes in WHO-ECOG 3 months post nephrectomy vs. baseline.
Time Frame: 1 year 3 months (Feb 2012 - may 2013)
1 year 3 months (Feb 2012 - may 2013)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mendus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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