ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01895491
Previous Study | Return to List | Next Study

Safety Study of VM206RY in Subjects With Expression of HER2 in Breast Cancer (VM206RY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01895491
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Reyon Pharmaceutical Co., Ltd.

Brief Summary:
The main objective of this study is to evaluate the safety of VM206RY in subjects with expression of HER2 in breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: VM206DNA Biological: VM206Ad Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Uncontrolled, Single Center, Phase I Trial to Assess the Safety of VM206RY in Subjects With Expression of Her2 in Breast Cancer
Study Start Date : March 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: CohortⅠ
VM206DNA 6mg and VM206Ad 3*10^9VP injected into the brachial muscle
Biological: VM206DNA
Biological: VM206Ad
Experimental: CohortⅡ
VM206DNA 12mg and VM206Ad 3*10^9VP injected into the brachial muscle
Biological: VM206DNA
Biological: VM206Ad
Experimental: CohortⅢ
VM206DNA 24mg and VM206Ad 3*10^9VP injected into the brachial muscle
Biological: VM206DNA
Biological: VM206Ad



Primary Outcome Measures :
  1. Adverse events (including serious adverse events and adverse events lead to treatment discontinuation) will be described according to severity and to their relationship with the study drug and injection procedure. [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) [ Time Frame: Up to 8 weeks ]
    DLT was defined as adverse events higher than grade 3 based on NCI CTCAE version 4.0 with respect to their relationship with the study drug and injection procedure until 2 weeks after final injection. MTD was defined as the highest dose evaluated for which less than 1/3 of the participants experienced DLT.

  2. Analysis of HER2 specific antibody formation in plasma at pre and post injection using ELISA or FACS [ Time Frame: Up to 24 weeks ]
  3. Analysis of HER2 specific CTL response on PBMC at pre and post injection using IFN-gamma ELISPOT [ Time Frame: Up to 24 weeks ]
  4. Assessment of tumor response based on the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) [ Time Frame: Up to 24 weeks ]
  5. Change of HER2 level in plasma at pre and post injection using ELISA [ Time Frame: Up to 24 weeks ]
  6. Analysis of GM-CSF level in plasma at pre and post injection using ELISA [ Time Frame: Up to be confirmed as negative ]
  7. Analysis of VM206Ad in whole blood at pre and post injection using Q-PCR [ Time Frame: Up to be confirmed as negative ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women, 20 years of age
  • Stage 3 or 4 breast cancer
  • Unresectable breast cancer with Expression of Her2 and one of the following criteria including

    • Prior use of Her2-targeted therapies(Herceptin, Tykerb, taxane and capecitabine) but it was not responding, with Immunohistochemistry (IHC) 3+, or IHC 2+ and FISH+, or SISH+
    • Patients received treatment that three times continuously Different chemotherapies but it was not responding, with Immunohistochemistry (IHC) 2+ and FISH- or SISH-, or Immunohistochemistry (IHC) 1+
    • Prior use of six chemotherapies(Anthracycline, Taxane, Gemcitabine, Capecitabine, Vinorelbine, Cyclophosphamide) but it was not responding, with Immunohistochemistry (IHC) 2+ and FISH or SISH-, or Immunohistochemistry (IHC) 1+
  • One or more measurable(or assessable) lesion of breast or metastatic site

    • Spiral CT: ≥ 10mm diameter
    • general measurement methods (CT, X-ray, MRI): ≥ 20mm diameter
  • Life expectancy 6 months
  • Signed informed consent

Exclusion Criteria:

  • Prior use of breast cancer vaccine
  • Active or history of cardiovascular diseases within the past 3 months: Active uncontrolled cardiac disease, including cardiomyopathy, CHF(NYHA Class III~IV), and unstable angina, family history of congenital long QT syndrome or QT/QTc interval >0.45 sec or torsade de points(TdP), and history of idiopathic ventricular tachycardia or ventricular fibrillation, LVEF < 50%
  • Patients with coronary artery disease (myocardial infarction, angina, etc.) or a history of coronary artery disease
  • Patients who is required hospitalization by severe fever or required antibiotic treatment by serious infection
  • Patients who is confirmed as CNS metastases. (Only, patient with stable brain metastases is permit. Among the patients who have not any symptom, do not see the progression before registered the last 2 month)
  • History of prior malignancies other than breast cancer within the past 5 years
  • Patients with an existing condition or a history of autoimmune disease or immunodeficiency disease
  • ECOG score ≥ 3
  • Patients with severe dysfunction in major organs

    • Blood: WBC < 3,000/㎕; Platelet < 100,000/㎕; Hematocrit < 30
    • Liver: Total bilirubin ≥ 1.5 x ULN; ALT/AST ≥ 2.5 x ULN
    • Kidney: Creatinine ≥ 1.5 x ULN
  • Abnormal values of anti-nuclear Ab, anti-double-stranded DNA and C3, as judged by the investigator
  • History of surgical procedure, chemotherapy, Herceptin treatment, corticosteroid therapy, immunosuppressant therapy or radiotherapy within the past 4 weeks
  • HIV Ag/Ab, HBs Ag, HCV Ab or HTLV-1 Ab positive
  • Psychotropic drug misuse/abuse or alcoholism
  • Prior use of vaccine within the past 4 weeks
  • Cumulative dose of prior doxorubicin > 360 ㎎/㎡ or epirubicin > 720 ㎎/㎡
  • Women who is pregnant or breastfeeding and don't agree to use a contraceptive during the study period.
  • Patients who have participated in clinical trials enrolled in this clinical trial within 4 weeks before. (Only patient, who has taken survey and DNA test without drug-treatment, has permit.)
  • Patients who are ineligible to participate in this study, as judged by the investigator.
  • Patients who prohibit administering GM-CSF and prior use of GM-CSF within the past 4 weeks.
  • Patients who expect hypersensitivity to investigational product (VM206RY) or any component of product.
  • Due to malignancy neoplasm, patients who require supplementary oxygen or has severe dyspnea at rest
  • Patients with hypertension [inadequately controlled hypertension (systolic > 180 mm Hg or diastolic > 100 mm Hg)] or a history of hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895491


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Reyon Pharmaceutical Co., Ltd.

Responsible Party: Reyon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01895491     History of Changes
Other Study ID Numbers: VM206RY-VM01
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: October 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases