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

• Sponsor: OBI Pharma, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01516307
• Collaborator: (none)
• Enrollment: 349
• Locations: 43
• Arms: 2
• Duration (Months): 92
• Patients Per Site: 8.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Dec 1, 2011
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [Progression or up to 2 years]

Secondary Outcome Measures

1. Overall Survival (OS) [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama at Birmingham (UAB)	Birmingham	Alabama	United States	35294
2	St. Jude Heritage Healthcare, Virginia K. Crosson Cancer Center	Fullerton	California	United States	92835
3	University of California, San Diego (UCSD)	La Jolla	California	United States	92093
4	University of California, Irvine (UCI)	Orange	California	United States	92868
5	University of California, San Francisco (UCSF)	San Francisco	California	United States	94115
6	Coastal Integrative Cancer Care	San Luis Obispo	California	United States	93401
7	Central Coast Medical Oncology Corporation	Santa Maria	California	United States	93454
8	University of California, Los Angeles (UCLA)	Santa Monica	California	United States	90404
9	Memorial Regional Hospital	Hollywood	Florida	United States	33021
10	University of Chicago Medical Center	Chicago	Illinois	United States	60637
11	Weill Cornell Medical College	New York	New York	United States	10065
12	Hope Women's Cancer Center	Asheville	North Carolina	United States	28801
13	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
14	UNIMED Medical Institute	Hong-Kong		China
15	HCG, Bangalore Institute of Oncology	Bengaluru		India
16	Curie Manavata Cancer Centre	Mumbai		India
17	Pusan National University Hospital	Busan-si		Korea, Republic of
18	Dong-A University Hospital	Busan		Korea, Republic of
19	Inha University Hospital	Chungcheongbuk-Do		Korea, Republic of
20	National Cancer Center	Chungcheongbuk-Do		Korea, Republic of
21	Kyungpook National University Medical Center	Daegu		Korea, Republic of
22	Yeungnam University Medical Center	Daegu		Korea, Republic of
23	Asan Medical Center	Seoul		Korea, Republic of
24	Korea University Anam Hospital	Seoul		Korea, Republic of
25	Seoul National University Hospital ,	Seoul		Korea, Republic of
26	Seoul St. Mary's Hospital	Seoul		Korea, Republic of
27	Severance Hospital	Seoul		Korea, Republic of
28	Changhua Christian Hospital	Changhua		Taiwan
29	Kaohsiung Medical University Hospital	Kaohsiung City		Taiwan
30	Kaohsiung Veterans General Hospital	Kaohsiung City		Taiwan
31	Chang Gung Memorial Hospital-KS	Kaohsiung		Taiwan
32	Chang Gung Memorial Hospital -Linkou	Linkou		Taiwan
33	Mackay Memorial Hospital	New Taipei City		Taiwan
34	China Medical University Hospital	Taichung		Taiwan
35	Taichung Veterans General Hospital	Taichung		Taiwan
36	Chi Mei Medical Center	Tainan City		Taiwan
37	National Cheng Kung University Hospital	Tainan		Taiwan
38	Koo Foundation Sun Yat-Sen Cancer Center	Taipei City		Taiwan
39	Taipei Veterans General Hospital	Taipei City		Taiwan
40	Chang Gung Memorial Hospital-Taipei	Taipei		Taiwan
41	National Taiwan University Hospital	Taipei		Taiwan
42	Shuang-Ho Hospital	Taipei		Taiwan
43	Tri-Service General Hospital	Taipei		Taiwan

Sponsors and Collaborators

• OBI Pharma, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: OBI Pharma, Inc
• ClinicalTrials.gov Identifier: NCT01516307
• Other Study ID Numbers: OPT-822-001
• First Posted: Jan 24, 2012
• Last Update Posted: Sep 16, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Cyclophosphamide

Study Results

No Results Posted as of Sep 16, 2020