unobaja, here is the trial and contact info, and I think I may speak for everyone on this board that our prayers are with you and you wife/family.
I lost my mother to Cancer, a young grandchild and many friends as they say everyone has lost someone to Cancer it truly is a disease that does not discriminate.
STUDY DIRECTOR: Patrick would be able to refer you to exact person if not him, as there are Mayo and Tapimmune's in house trial, either way he will be able to direct you.
Contact: Patrick D Yeramian, MD 904 677 3597 pyeramian@tapimmune.com
Contact: Ana Aleman, MD 904 533 6012 aaleman@tapimmune.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT02593227
OR
CLINICAL TRIALS REFERRAL COORDINATOR
CONTACT: TONI KAY MANGSKAU
855 776 0015
Tapimmune trial info:
Not yet recruiting Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer
Condition:
Breast Cancer
Interventions:
Biological: Low dose FRa vaccine; Drug: Cyclophosphamide; Biological: High dose FRa vaccine
Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer
This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2015 by Tapimmune Inc.
Sponsor:
Tapimmune Inc.
Information provided by (Responsible Party):
Tapimmune Inc.
ClinicalTrials.gov Identifier:
NCT02593227
First received: October 27, 2015
Last updated: October 30, 2015
Last verified: October 2015
History of Changes
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No Study Results Posted
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How to Read a Study Record
Purpose
This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRa) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC).
Condition
Intervention
Phase
Breast Cancer
Biological: Low dose FRa vaccine
Drug: Cyclophosphamide
Biological: High dose FRa vaccine
Phase 2
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of Vaccination With Folate Receptor Alpha Peptides With GM-CSF in Patients With Triple Negative Breast Cancer
Resource links provided by NLM:
Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: B Vitamins Breast Cancer
Drug Information available for: Cyclophosphamide
U.S. FDA Resources
Further study details as provided by Tapimmune Inc.:
Primary Outcome Measures: •Immune response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Emergence of B and T cell immunity targeting the folate receptor alpha
Secondary Outcome Measures: •Folate receptor alpha expression [ Time Frame: Baseline ] [ Designated as safety issue: No ]
To determine FRa expression status of primary tumors
•Relapse Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
RFS in relation to FR specific immune response
•Objective response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
ORR in the subset of patients with residual disease
•Safety and tolerability (treatment emergent adverse events and injection site reactions) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Incidence of treatment emergent adverse events and injection site reactions
Estimated Enrollment: 80
Study Start Date: December 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Experimental: Low dose FRa vaccine
FRa peptide vaccine with GM-CSF adjuvant - single ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Biological: Low dose FRa vaccine
165ug per peptide ID injection
Other Name: TPIV200
Experimental: High dose FRa vaccine
FRa peptide vaccine with GM-CSF adjuvant - triple ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Biological: High dose FRa vaccine
500ug per peptide ID injection
Other Name: TPIV200
Experimental: Low dose FRa vaccine + cyclophosphamide
Cyclophosphamide 300 mg/sqm as a 1 hour IV infusion 3 days prior to first vaccination. Followed by FRa peptide vaccine with GM-CSF adjuvant - ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Biological: Low dose FRa vaccine
165ug per peptide ID injection
Other Name: TPIV200
Drug: Cyclophosphamide
IV infusion over 1 hour
Other Name: Cytoxan
Experimental: High dose FRa vaccine + cyclophosphamide
Cyclophosphamide 300 mg/sqm as a 1 hour IV infusion 3 days prior to first vaccination. Followed by FRa peptide vaccine with GM-CSF adjuvant - ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Drug: Cyclophosphamide
IV infusion over 1 hour
Other Name: Cytoxan
Biological: High dose FRa vaccine
500ug per peptide ID injection
Other Name: TPIV200
Detailed Description:
Triple negative breast cancers (TNBCs) occur in approximately 20-25% of all patients with breast cancer and are associated with a poor prognosis. Patients with TNBCs derive no benefit from targeted therapies. Excluding those patients who demonstrate a pathologic complete response following neoadjuvant chemotherapy, which is a minor fraction (i.e. 15%), overall survival is only 45% at 7 years.
Following standard of care, there are windows of opportunity to further and safely treat patients to prevent recurrence. Stimulating the immune system to produce T cells immunity specific for tumor antigens may significantly delay recurrence and cure patients.
The proposed vaccine is intended to induce T cells to survey for the reemergence of TNBCs and to prevent recurrence in the adjuvant setting. The vaccine strategy is antigen-specific and targets the Folate Receptor Alpha (FRa). FRa is an ideal target because of its limited expression in the healthy tissues and it high expression in 86% of TNBCs. Studies have shown that it is a biologically important marker that is associated with poorer clinical outcome and is retained in metastatic lesions.
The FRa vaccine include a pool of 5 peptides that are immunogenic epitopes and safely generate tissue-surveying CD4 T cell immune responses in patients tested in a recently completed phase I clinical trial.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
•Female patient, Age 18 years or older;
•Written informed consent;
•Negative for ER, PR and negative for Her2-neu (0 or 1+ on immunohistochemistry and/or normal gene copy number by fluorescence in-situ hybridization);
•Completed surgery and radio/chemotherapy in adjuvant or neo-adjuvant setting.
•Completed last cycle of chemotherapy or radiation > 60 days prior to consent
•Unilateral or bilateral primary carcinoma of the breast with tumor Stage II-III according to AJCC 7th edition, and one of the following:
a.For patient treated in the neoadjuvant setting: Histologically detectable tumor residuals (ypT0/is ypN0), M0 and no evidence of gross tumor or gross residual adenopathy.
b.For patients treated in the adjuvant setting: pN2-3 and M0. No evidence of gross tumor or gross residual adenopathy
c.Patient with residual clinical disease after neoadjuvant or adjuvant therapy, M0
•Adequate Blood, renal and hepatic function, as determined within 28 days from enrollment:
Exclusion Criteria:
•Clinical evidence of distant metastases per practice guidelines for breast cancer;
•Inflammatory breast cancer or tumor with deep adherence or cutaneous invasion;
•Known hypersensitivity reaction to the GM-CSF adjuvant; Any known contra-indication to GM-CSF or Cyclophosphamide treatment;
•Pregnant or lactating patients.
•History of auto-immune diseases;
•Other uncontrolled illness or medical condition , such as active infection, symptomatic heart failure, unstable angina pectoris, myocardial infarction or stroke within last 6 months, psychiatric illness that may limit compliance with study requirement or interfere with the understanding and giving of informed consent;
•Prior active secondary malignancy < 5 years prior to consent (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) or currently receiving other specific treatment for this cancer (including monoclonal antibody or pathway inhibitor);
•Completed treatment with systemic corticosteroid or immune-modulators > 30 days prior to registration;
•Planned treatment with other experimental drugs or any other anti-cancer therapy;
•Immunocompromised patients including patients with known HIV infection;
•Currently receiving thyroid replacement therapy.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02593227
Contacts
Contact: Patrick D Yeramian, MD 904 677 3597 pyeramian@tapimmune.com
Contact: Ana Aleman, MD 904 533 6012 aaleman@tapimmune.com
Sponsors and Collaborators
Tapimmune Inc.
Investigators
Study Director: Patrick D Yeramian, MD Tapimmune Inc.
More Information
Additional Information:
Corporate website This link exits the ClinicalTrials.gov site
No publications provided
Responsible Party: Tapimmune Inc.
ClinicalTrials.gov Identifier: NCT02593227 History of Changes
Other Study ID Numbers: FRV-002
Study First Received: October 27, 2015
Last Updated: October 30, 2015
Health Authority: United States: Food and Drug Administration
Keywords provided by Tapimmune Inc.:
TNBC
Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
ClinicalTrials.gov processed this record on December 04, 2015
My family's prayers are with you.
GLTA
BLU
