Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    KLH | First posted from 01/01/2012 to 01/29/2012

Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects

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: NCT01516307
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
OBI Pharma, Inc

Tracking Information
First Submitted Date  ICMJE January 19, 2012
First Posted Date  ICMJE January 24, 2012
Last Update Posted Date September 16, 2020
Study Start Date  ICMJE December 2011
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
Progression Free Survival (PFS) [ Time Frame: Progression or up to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
Overall Survival (OS) [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects
Official Title  ICMJE A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer
Brief Summary The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Biological: OPT-822/OPT-821(30 μg/100 μg)
    Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37. OPT-822 and OPT-821 are combined at time of injection.
  • Biological: Phosphate Buffer Saline (PBS)
    Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.
  • Drug: Cyclophosphamide
    Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.
Study Arms  ICMJE
  • Experimental: OPT-822/OPT-821 (30 μg/100 μg) and Cyclophosphamide
    Patients will be randomized 2:1 to receive OPT-822/OPT-821(30 μg/100 μg) plus Cyclophosphamide IV (300mg/m2).
    Interventions:
    • Biological: OPT-822/OPT-821(30 μg/100 μg)
    • Drug: Cyclophosphamide
  • Placebo Comparator: Phosphate Buffer Saline (PBS) and Cyclophosphamide
    Patients will receive Phosphate Buffer Saline (PBS) plus Cyclophosphamide IV (300mg/m2).
    Interventions:
    • Biological: Phosphate Buffer Saline (PBS)
    • Drug: Cyclophosphamide
Publications * Huang CS, Yu AL, Tseng LM, Chow LWC, Hou MF, Hurvitz SA, Schwab RB, L Murray J, Chang HK, Chang HT, Chen SC, Kim SB, Hung JT, Ueng SH, Lee SH, Chen CC, Rugo HS. Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 in patients with metastatic breast cancer: phase II randomized, placebo-controlled study. J Immunother Cancer. 2020 Jul;8(2). pii: e000342. doi: 10.1136/jitc-2019-000342.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2016)
349
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2012)
342
Actual Study Completion Date  ICMJE August 2019
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female subjects ≥ 21 years of age with histological or cytological diagnosis of breast carcinoma.
  • Subjects with metastatic breast cancer who have achieved stable disease (SD), partial response (PR), or complete response (CR) after at least 1 regimen of anticancer therapy (i.e. chemotherapy or target therapy, either alone or in any combination). Involvement of supraclavicular lymph node is considered metastasis.
  • Subjects must have recovered from toxicities of prior therapies. (i.e. CTCAE ≤ grade 2).
  • Performance status: ECOG ≤ 1 and life expectancy ≥ 3 months.
  • Organ Function Requirements - Subjects must have adequate organ functions as defined below:

    • AST/ALT ≤ 3X ULN (upper limit of normal)
    • AST/ALT ≤ 5X ULN [with underlying Liver Metastasis]
    • Total Bilirubin ≤ 2.0 X ULN
    • Serum Creatinine ≤ 1.5X ULN
    • ANC ≥ 1500 /μL
    • Platelets > 100,000/μL
    • No Symptomatic Congestive Heart Failure (Ejection Fraction EF ≥ 50%)
  • Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
  • All positive or negative ER (estrogen receptor), PR (progesterone receptor), and HER-2 subjects are eligible for this study.
  • However, subjects who are HER-2 positive and responsive to anti-HER-2 therapy (e.g. Herceptin), are encouraged to remain on anti-HER-2 therapy and not enroll in this trial.
  • Subjects who desire to enroll in this study and for whom anti-HER-2 therapy is not available or contraindicated, may be eligible to enroll in this trial.
  • In countries where continuous anti-HER2 therapy is considered standard of care for HER-2 positive metastatic disease, HER-2 positive subjects are not eligible.
  • Women of childbearing potential must be willing to implement adequate contraception during the study. An adequate method of contraception will be at the investigator's discretion.

Exclusion Criteria:

  • Subjects are pregnant or breast-feeding at entry.
  • Subjects with more than 2 events of disease progression after the development of metastatic breast cancer.
  • Subjects who are currently receiving any other concomitant anticancer therapy with the EXCEPTION of bisphosphonates and hormone therapy.

    • During the study period, subjects using hormonal therapy and bisphosphonates should maintain a constant dose and should not change existing regimen.
    • However, if a change in hormonal therapy is indicated, e.g. due to intolerable adverse effects, the regimen may be modified but change should be minimized thereafter.
  • Subjects with metastasis limited to the bone only are excluded. However, subjects with current metastasis limited to the bone only and with a history of distant metastasis are eligible. Subjects with current metastasis limited to the bone only and with current breast tissue lesion are eligible.
  • Subjects who have any history of other malignancy (except non-melanoma skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry.
  • Subjects with splenectomy.
  • Subjects with HIV infection.
  • Subjects with any major autoimmune diseases or autoimmune disorders requiring systemic iv/oral steroids or immunosuppressive or immunomodulatory therapies.

    • e.g. Type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Grave's disease, Hashimoto's thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, etc
    • Autoimmune disorders confined to the skin (e.g. psoriasis) are eligible, and topical steroids are allowed for the treatment of such skin disorders.
  • Subjects with any known uncontrolled inter-current illness including ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Subjects with any of the following MEDICATIONS within 4 weeks prior to randomization:

    • Anti-neoplastic agents
    • Immunotherapy [mAbs, Interferons, Cytokines (except GCSF)]
    • Immunosuppressants (e.g. Cyclosporin, Rapamycin, Tacrolimus, Rituximab, Alemtuzumab, Natalizumab, etc.).
    • Another investigational drug
  • Subjects with pleural effusions and/or ascites, due to malignancy, requiring paracentesis every 2 weeks or more frequently.
  • Subjects with any known severe allergies (e.g. anaphylaxis) to any active or inactive ingredients in the study drugs.
  • Subjects with bladder inflammation and urinary outflow obstruction.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   India,   Korea, Republic of,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01516307
Other Study ID Numbers  ICMJE OPT-822-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party OBI Pharma, Inc
Study Sponsor  ICMJE OBI Pharma, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account OBI Pharma, Inc
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP