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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
OBI Pharma, Inc
ClinicalTrials.gov Identifier:
NCT01516307
First received: January 19, 2012
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Biological: OPT-822/OPT-821
Biological: Phosphate Buffer Saline (PBS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by OBI Pharma, Inc:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Progression or up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 342
Study Start Date: December 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPT-822/OPT-821
OPT-822 (equivalent to 30 μg of Globo H) in PBS mixed with OPT-821 (100 μg) PBS.
Biological: OPT-822/OPT-821
Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37 (visit 3, 4, 5, 7, 9, 11, 13, 15, and 18).
Placebo Comparator: Phosphate Buffer Saline (PBS) Biological: Phosphate Buffer Saline (PBS)
Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37 (visit 3, 4, 5, 7, 9, 11, 13, 15, and 18).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01516307

  Show 43 Study Locations
Sponsors and Collaborators
OBI Pharma, Inc
  More Information

No publications provided

Responsible Party: OBI Pharma, Inc
ClinicalTrials.gov Identifier: NCT01516307     History of Changes
Other Study ID Numbers: OPT-822-001
Study First Received: January 19, 2012
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration
Taiwan : Food and Drug Administration
Taiwan: Center for Drug Evaluation
Taiwan: Institutional Review Board
Hong Kong: Department of Health
Hong Kong: Ethics Committee
South Korea: Ministry of Food and Drug Safety
India: Central Drugs Standard Control Organization

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

ClinicalTrials.gov processed this record on November 27, 2014