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

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ClinicalTrials.gov Identifier: NCT01516307
Recruitment Status : Active, not recruiting
First Posted : January 24, 2012
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
OBI Pharma, Inc

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Biological: OPT-822/OPT-821(30 μg/100 μg) Biological: Phosphate Buffer Saline (PBS) Drug: Cyclophosphamide Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2011
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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).
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.

Drug: Cyclophosphamide
Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.

Placebo Comparator: Phosphate Buffer Saline (PBS) and Cyclophosphamide
Patients will receive Phosphate Buffer Saline (PBS) plus Cyclophosphamide IV (300mg/m2).
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.




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Progression or up to 2 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes 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.

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): NCT01516307


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Sponsors and Collaborators
OBI Pharma, Inc

Responsible Party: OBI Pharma, Inc
ClinicalTrials.gov Identifier: NCT01516307     History of Changes
Other Study ID Numbers: OPT-822-001
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists