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Clinical Trials/KCT0000707
KCT0000707Active, not recruiting未知

A Double-blind, Randomized Phase II/III Trial of Active Immunotherapy with Globo H-KLH (OPT-822) in Subjects with Metastatic Breast Cancer

Choice Pharma Korea0 sites342 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
未知
Status
Active, not recruiting
Sponsor
Enrollment
342
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional Study

Eligibility Criteria

Ages
21(Year) to o Limit (—)
Sex
Female

Inclusion Criteria

  • •1. Female subjects =21 years of age with histological or cytological diagnosis of breast carcinoma.
  • •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 anticancer therapy (i.e. chemotherapy or target therapy or hormone therapy, either alone or in any combination).
  • •Involvement of supraclavicular lymph node is considered metastasis.
  • •3. Subjects must have recovered from toxicities of prior therapies. (i.e., CTCAE ? grade 2).
  • •4. Performance status: ECOG ? 1 and life expectancy ³ 3 months.
  • •5. 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 ³ 1500 /µL
  • •- Platelets > 100,000/µL
  • •- No Symptomatic Congestive Heart Failure (Ejection Fraction EF 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 be willing to implement adequate contraception during the study. An adequate method of contraception will be at the Investigator’s discretion.

Exclusion Criteria

  • •1. Subjects are pregnant or breast-feeding at entry.
  • •2. Subjects with more than 2 events of disease progression 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 are excluded.
  • •- Subjects with current metastasis limited to the bone only and with a HISTORY of distant metastases are eligible.
  • •- Subjects with current metastasis limited to the bone only and with CURRENT
  • •breast tissue lesion are eligible.
  • •5. Subjects with evidence or history of CNS metastases.
  • •6. 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.
  • •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, 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.
  • •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, due to malignancy, 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.
  • •14. Subjects with bladder inflammation and urinary outflow obstruction.

Investigators

Sponsor
Choice Pharma Korea

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