Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects
- Conditions
- Health Condition 1: null- Metastatic Breast Cancer
- Registration Number
- CTRI/2013/06/003778
- Lead Sponsor
- OBI Pharma INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 342
1.Female subjects >=21 years of age with histological or cytological diagnosis of breast cancer.
2. Subjects with metastatic breast cancer who have achieved stable disease (SD), partial
response (PR), or complete response (CR) after at least 1 regimen of chemotherapy.
3. Subjects must have recovered from toxicities of prior therapies. (i.e. CTCAE - grade 2).
4. Performance status: ECOG - 1 and life expectancy - 3 months.
5. Organ Function Requirements â?? Subjects must have adequate organ functions as defined
below:
- AST/ALT <= 3X ULN (upper limit of normal)
- AST/ALT ï?£ 5X ULN [with underlying Liver Metastasis]
- Total Bilirubin ï?£ 2.0 X ULN
- Serum Creatinine ï?£ 1.5X ULN
- ANC - 1500 /μL
- Platelets > 100,000/μL
- No Symptomatic Congestive Heart Failure (Ejection Fraction EF ï?³ 50%)
6. Ability to understand and the willingness to sign a written informed consent document
according to institutional guidelines.
7. All positive or negative ER (estrogen receptor), PR (progesterone receptor), 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.
8. Women of childbearing potential must implement adequate contraception in the opinion of the investigator.
1. Subjects are pregnant or breast-feeding at entry.
2. Subjects with more than 2 events of disease progression (PD) after the development of
metastatic breast cancer.
3. 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.
4. Subjects with metastasis limited to the bone only and with no history of other visceral or
soft tissue metastases.
5. Subjects with evidence or history of CNS metastases.
6. Subjects who have any history of other malignancy (except basal cell skin carcinoma and
carcinoma-in-situ of the uterine cervix) within 5 years of study entry.
7. Subjects with splenectomy.
8. Subjects with HIV infection.
9. 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,
Graveâ??s disease, Hashimotoâ??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.
10. Subjects with any known uncontrolled inter-current illness including ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with study
requirements.
11. Subjects with any of the following MEDICATIONS within 4 weeks prior to randomization:
- Anti-neoplastic agents
- Immunotherapy [mAbs, Interferons, Cytokines (except GCSF)]
- Immunosuppressants (Cyclosporin, Rapamycin, Tacrolimus, Rituximab, etc.)
- Another investigational drug
12. Subjects with pleural effusions and/or ascites requiring paracentesis every 2 weeks or more frequently.
13. Subjects with any known severe allergies (e.g. anaphylaxis) to any active or inactive
ingredients in the study drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) <br/ ><br>Timepoint: Progression or up to 2 years
- Secondary Outcome Measures
Name Time Method Overall Survival (OS)Timepoint: Time Frame: 5 years