Try our beta test site
Trial record 1 of 1 for:    NCT02686944
Previous Study | Return to List | Next Study

A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors (GIST)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2015 by Immunicum AB
Sponsor:
Information provided by (Responsible Party):
Immunicum AB
ClinicalTrials.gov Identifier:
NCT02686944
First received: January 19, 2016
Last updated: February 16, 2016
Last verified: December 2015
  Purpose
The study is a prospective single armed, open label phase I study. Patients with advanced or metastatic GIST and tumor progression despite ongoing treatment with second-line Sunitinib treatment, and with at least one measureable tumor lesion, will be eligible for the study. A maximum of 12 patients will be included in this study. The patients will continue with Sunitinib treatment until the 3 months follow up visit. If further tumor progression Sunitinib will be withdrawn but if stable disease or objective response the patient will continue with Sunitinib until progress. The investigational product Intuvax will be injected into a tumor lesion at two or three treatment occasions; day 1, 14 days (±3 days) after the first vaccination, and 28 days (±3 days) after the second vaccination (patient 7-12 only). Intuvax will be injected in a viable part of the tumor, using ultrasound-guided or CT technique for correct administration.

Condition Intervention Phase
Gastrointestinal Stromal Tumor
Biological: Intuvax (suspension for intratumoral injection)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Open-label Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax in Patients With Progressing Gastrointestinal Stromal Tumors (GIST) During Ongoing Second-Line Treatment With Sunitinib. A Prospective Single Armed, Open Label Phase I Safety and Efficacy Study

Resource links provided by NLM:


Further study details as provided by Immunicum AB:

Primary Outcome Measures:
  • Changes in vital signs (heart rate, blood pressure, body temperature) [ Time Frame: Within 6 hours after each vaccination of Intuvax and at 3 and 6 months versus baseline ]
  • Changes in lab parameters (biochemistry, haematology) [ Time Frame: Just before vaccination 1, at 14 days after vaccination 1, at 28 days after vaccination 2, at 3 and 6 months after vaccination 1 ]
  • Adverse events [ Time Frame: At time of vaccination 1 and through study completion, an average of 6 months ]
  • Changes in lab parameters (coagulation) [ Time Frame: Just before vaccination 1, at 14 days after vaccination 1 and at 28 days after vaccination 2 ]

Secondary Outcome Measures:
  • Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to mRECIST [ Time Frame: Within 2 weeks of vaccination 1 and at 3 and 6 months after vaccination 1 ]
    Criteria based on the diameter of the contrast-enhanced portions of the tumor

  • Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to RECIST 1.1. [ Time Frame: Within 2 weeks of vaccination 1 and at 3 and 6 months after vaccination 1 ]
    Criteria based on the maximal tumor diameter

  • Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to Choi criteria [ Time Frame: Within 2 weeks of vaccination 1 and at 3 and 6 months after vaccination 1 ]
    Criteria based on unidimensional tumor size and tumor density on contrast-enhanced CT images.

  • Progression free survival according to mRECIST [ Time Frame: Within 2 weeks of vaccination 1 and at 3 and 6 months after vaccination 1 ]
    Criteria based on the diameter of the contrast-enhanced portions of the tumor

  • Progression free survival according to RECIST 1.1 [ Time Frame: Within 2 weeks of vaccination 1 and at 3 and 6 months after vaccination 1 ]
    Criteria based on the maximal tumor diameter

  • Progression free survival according to Choi criteria [ Time Frame: Within 2 weeks of vaccination 1 and at 3 and 6 months after vaccination 1 ]
    Criteria based on unidimensional tumor size and tumor density on contrast-enhanced CT images.

  • Changes in WHO-ECOG score [ Time Frame: At 3 and 6 months versus baseline ]
  • Levels of autoimmunization parameters [ Time Frame: Within 2 weeks of vaccination and at 3 months after vaccination 1 ]
    Screening of autoantibodies against nuclear antigens (ANA), including the nuclear antigens SSA, SSB, Sm, RNP, Scl-70, Centromeres and Jo-1

  • Levels of alloimmunization parameters [ Time Frame: Within 2 weeks of vaccination and at 3 months after vaccination 1 ]
    Screening of alloantibodies against HLA-A, B, C (MHC-class I) and HLA-DR (MHC-class II) antigens


Estimated Enrollment: 12
Study Start Date: February 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intuvax

Intuvax will be administered 2 or 3 times. First injection Day 1 (pat 1-12), second injection 14 days after the first vaccination (pat 1-12), third injection 28 days after the second vaccination (only pat 7-12).

Max 10 000000 allogeneic dendritic cells/ml per injection.

Biological: Intuvax (suspension for intratumoral injection)
Therapeutic vaccine: allogeneic, proinflammatory dendritis cells

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 GIST according to modified NIH criteria, 2011, where curative excision is no longer an option, i.e. confirmed unresectable or metastatic GIST, and that has progressed on both first (imatinib) and second line (Sunitinib) tyrosine kinase inhibitor (TKI) treatment.
  4. Radiologically measurable tumor(s), i.e at least 3 cm in longest uni-dimensional diameter as measured by CT
  5. Clinical and/or CT verified disease progression despite ongoing second-line treatment with Sunitinib
  6. Female who has been post-menopausal for more than one (1) year or female of childbearing potential using a highly efficient method of contraception (i.e. a method with less than 1% failure rate [e.g. sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner with combined use of condom and/or birth control pills]) during study participation. Female of childbearing potential must have a negative blood pregnancy test at Screening, and if randomized to vaccination a negative blood or urine pregnancy test within one (1) day before each dose of Intuvax, or Male agreeing to use condoms during the study participation or male having a female partner who is using a highly efficient method of contraception as described above during the partner's study participation.

Exclusion Criteria:

  1. Performance status > ECOG 2
  2. Known major reaction/adverse event in connection with previously made vaccination (e.g. asthma, anaphylaxia or other serious reaction)
  3. Known major reaction/adverse event in connection with previous transfusions of blood products
  4. Active autoimmune disease requiring 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. Tested positive for HIV
  6. Active virus disease (HBV and HCV).
  7. Ongoing infection that requires treatment with parenteral antibiotics or antiviral medication
  8. Corticosteroid treatment (within 7 days) prior to the first injection of Intuvax. Inhaled, intranasal and local steroids accepted.
  9. Inadequate laboratory parameters, i.e.:

    • B-Leukocyte count < 4.5 x109/L
    • B-Platelet count < 75 x109/L
    • B-Hemoglobin < 100 g/L
    • P-Prothrombincomplex (PK) >1.4
    • P-APT time outside normal limit
  10. Previous organ transplantation
  11. Pregnant or lactating women
  12. Life expectancy less than 3 months.
  13. Investigational treatment (within 28 days) prior to the first injection of Intuvax
  14. Known blood dyscrasia (bleeding complication)
  15. 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: NCT02686944

Contacts
Contact: Linda Barkemo +46 31 405050 linda.barkemo@immunicum.com

Locations
Sweden
Department of Breast and Endocrine Surgery, Section of Endocrine and Sarcoma Surgery, Karolinska University Hospital Not yet recruiting
Stockholm, Sweden, SE-171 76
Contact: Robert Bränström, MD, PhD    +46 8 51779213    robert.branstrom@ki.se   
Sponsors and Collaborators
Immunicum AB
Investigators
Study Director: Linda Barkemo Immunicum AB
  More Information

Responsible Party: Immunicum AB
ClinicalTrials.gov Identifier: NCT02686944     History of Changes
Other Study ID Numbers: EudraCT-no: 2015-002689-22 
Study First Received: January 19, 2016
Last Updated: February 16, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Immunicum AB:
GIST

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 20, 2017