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A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer

Phase 2
21 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer

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

- Performance status: ECOG ≤ 1 and life expectancy ≥ 3 months.

- Organ Function Requirements - Subjects must have adequate organ functions as defined

- 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

- 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

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Time Frame:

Progression or up to 2 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

December 2016

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms



Emory University Atlanta, Georgia  30322
University of Chicago Medical Center Chicago, Illinois  60637
University of Texas MD Anderson Cancer Center Houston, Texas  77030
Memorial Regional Hospital Hollywood, Florida  33021
The Methodist Hospital Research Institute Houston, Texas  77030
Central Coast Medical Oncology Corporation Santa Maria, California  93454
Weill Cornell Medical College New York, New York  10021
University of California, Los Angeles (UCLA) Los Angeles, California  90095-1740
The University of Alabama at Birmingham (UAB) Birmingham, Alabama  35294
University of California, San Diego (UCSD) La Jolla, California  92093
University of California, Irvine (UCI) Orange, California  92868
University of California, San Francisco (UCSF) San Francisco, California  94115
Coastal Integrative Cancer Care San Luis Obispo, California  93401
St. Jude Heritage Healthcare, Virginia K. Crosson Cancer Center Fullerton, California  92835