A Clinical Study to Evaluate Safety and Immunologic Response of COMBIG-DC, in Patients With Metastatic Kidney Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Immunicum AB
ClinicalTrials.gov Identifier:
NCT01525017
First received: January 20, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Biological: Combig-DC (allogeneic dendritic cells) Cancer Vaccine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Open-label Study to Evaluate Safety and Immunologic Response of COMBIG-DC Administered Intratumorally in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Immunicum AB:

Primary Outcome Measures:
  • Registration of adverse events as a measure of safety and tolerability [ Time Frame: 1 year 3 months (Feb 2012-May 2013) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Changes in lab parameters from baseline as a measure of safety and tolerability [ Time Frame: 1 year 3 months (Feb 2012 - May 2013) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunologic response in blood (immunologic panel) measured with ELISPOT. [ Time Frame: 1 year 3 months (Feb 2012 - May 2013) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
  • CT-evaluation of the size of the metastasis(-es) 3 months post nephrectomy [ Time Frame: 1 year 3 months (Feb 2012 - March 2013) ] [ Designated as safety issue: No ]
  • CT evaluation to evaluate number of metastases 3 months post nephrectomy. [ Time Frame: 1 year 3 months (Feb 2012 - May 2013) ] [ Designated as safety issue: No ]
  • Changes in body weight 3 months post nephrectomy vs. baseline. [ Time Frame: 1 year 3 months (Feb 2012 - May 2013) ] [ Designated as safety issue: No ]
  • Changes in WHO-ECOG 3 months post nephrectomy vs. baseline. [ Time Frame: 1 year 3 months (Feb 2012 - may 2013) ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: February 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525017

Locations
Sweden
Dept of Oncology, University Hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Immunicum AB
Investigators
Principal Investigator: Anna Laurell, MD, PhD Dept of Oncology , Uppsala University Hospital
  More Information

No publications provided

Responsible Party: Immunicum AB
ClinicalTrials.gov Identifier: NCT01525017     History of Changes
Other Study ID Numbers: IM-101, 2011-002039-25
Study First Received: January 20, 2012
Last Updated: October 23, 2013
Health Authority: Sweden:Swedish Medical Products Agency
Sweden:Regional Ethics Review Board, Uppsala

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014