Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01525017
Other study ID # IM-101
Secondary ID 2011-002039-25
Status Completed
Phase Phase 1
First received January 20, 2012
Last updated October 9, 2015
Start date February 2012
Est. completion date December 2013

Study information

Verified date October 2015
Source Immunicum AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products AgencySweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Sweden Dept of Oncology, University Hospital Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Immunicum AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Registration of adverse events as a measure of safety and tolerability 1 year 3 months (Feb 2012-May 2013) Yes
Primary Changes in vital signs from baseline (heart rate, blood pressure, body temperature) as a measure of safety and tolerability 1 year 3 months (Feb 2012 - May 2013) Yes
Primary Changes in lab parameters from baseline as a measure of safety and tolerability 1 year 3 months (Feb 2012 - May 2013) Yes
Secondary Immunologic response in blood (immunologic panel) measured with ELISPOT. 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) No
Secondary Examination of immunohistology parameters (macrophage marker, CD3, CD4, CD8, CD56) of the renal tumor post nephrectomy. 1 year 3 months (Feb 2012 - May 2013) No
Secondary CT-evaluation of the size of the metastasis(-es) 3 months post nephrectomy 1 year 3 months (Feb 2012 - March 2013) No
Secondary CT evaluation to evaluate number of metastases 3 months post nephrectomy. 1 year 3 months (Feb 2012 - May 2013) No
Secondary Changes in body weight 3 months post nephrectomy vs. baseline. 1 year 3 months (Feb 2012 - May 2013) No
Secondary Changes in WHO-ECOG 3 months post nephrectomy vs. baseline. 1 year 3 months (Feb 2012 - may 2013) No
See also
  Status Clinical Trial Phase
Completed NCT00930033 - Clinical Trial to Assess the Importance of Nephrectomy Phase 3
Recruiting NCT05863351 - Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study Phase 3
Not yet recruiting NCT06284564 - A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC) Phase 2
Completed NCT00414765 - Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma Phase 4
Active, not recruiting NCT03149822 - Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma Phase 1/Phase 2
Recruiting NCT03647878 - Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.
Completed NCT01517243 - Phase II Study of Alternating Sunitinib and Temsirolimus Phase 2
Withdrawn NCT03927248 - PAC-1 for Treatment of Refractory, Metastatic Kidney Cancer Phase 1/Phase 2
Terminated NCT02122003 - Second Line Sorafenib After Pazopanib in Patients With RCC Phase 2
Completed NCT01182142 - Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients Phase 2
Completed NCT00630409 - Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma Phase 2
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1/Phase 2
Completed NCT04076787 - Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
Active, not recruiting NCT04467021 - Cancer and Blood Pressure Management, CARISMA Study N/A
Recruiting NCT05119335 - A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma Phase 1/Phase 2
Completed NCT02282579 - Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy
Terminated NCT02071641 - Phase II Study of Sunitinib Rechallenge in Patients With Metastatic Renal Cell Carcinoma Phase 2
Completed NCT01731158 - Sequential Therapy in Metastatic Renal Cell Carinoma Phase 2
Terminated NCT01342627 - Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma Phase 2
Active, not recruiting NCT01274273 - Study of Interleukin-2, Interferon-alpha and Bevacizumab in Metastatic Kidney Cancer Phase 2