BriaVax™ in Metastatic or Locally Recurrent Breast Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase I/IIa Study of the Whole-Cell Vaccine BriaVax™ in Metastatic or Locally Recurrent Breast Cancer Patients|
- Incidence of Treatment Emergent Adverse Events [Safety] [ Time Frame: Through study completion, an average of 1 year ]To evaluate the incidence of toxicity events while on BriaVax, as defined by CTCAE
- Duration of Treatment Emergent Adverse Events [Safety] [ Time Frame: Through study completion, an average of 1 year ]To evaluate the duration of toxicity events while on BriaVax, as defined by CTCAE
- Relationship of Adverse Events to BriaVax [Safety] [ Time Frame: Through study completion, an average of 1 year ]To evaluate the relationship of toxicity events, as defined by CTCAE, to BriaVax administration
- Objective Tumor Response Rate [ Time Frame: Through study completion, an average of 1 year ]Objective response rate (ORR), defined as complete response (CR) or partial response (PR) per immune-related response criteria (irRC)
- Rate of Non-progression of Tumors [ Time Frame: Through study completion, an average of 1 year ]Non-progressive rate, defined as CR, PR or stable disease (SD) per irRC
- Durability of Tumor Response [ Time Frame: Through study completion, an average of 1 year ]Durability of response, by evaluating those patients eligible to complete the optional treatments from 9-12 months
- Immune responses to vaccine [ Time Frame: Through study completion, an average of 1 year ]To assess immune responses to vaccine, and to recall antigens, if any, as measured by DTH skin tests and/or other immunological tests
- Quality of Life using the SF-36 Health Survey [ Time Frame: Through study completion, an average of 1 year ]To measure the quality of life (QOL) of participants using the SF-36 Health Survey, which includes measures of General Health, Limitations of Activity, Physical Health Problems, Emotional Health Problems, Social Activities, Energy and Emotions.
- Weight [ Time Frame: Through study completion, an average of 1 year ]To measure changes in weight.
- Performance status [ Time Frame: Through study completion, an average of 1 year ]To measure changes in performance status using the Eastern Cooperative Oncology Group (ECOG) scale
- Pain (pain scale) [ Time Frame: Through study completion, an average of 1 year ]To measure changes in pain using a scale from None to Very Mild to Mild to Moderate to Severe to Very Severe
|Anticipated Study Start Date:||March 10, 2017|
|Estimated Study Completion Date:||March 2020|
|Estimated Primary Completion Date:||February 2020 (Final data collection date for primary outcome measure)|
Experimental: BriaVax™ Monotherapy
Pretreatment with low dose cyclophosphamide 2-3 days prior to BriaVax™ inoculation; BriaVax™ inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after BriaVax™ inoculation
See aboveDrug: Cyclophosphamide
Low dose pre-treatment to reduce regulatory T cells
Other Name: CytoxanBiological: Interferon-alpha-2b
Low dose given in the vaccine site to boost the immune response
Other Name: Intron A
This is a single arm, open label study of BriaVax™ in recurrent and/or metastatic breast cancer. The detailed treatment regimen follows:
Cyclophosphamide (Cytoxan) 300 mg/m2 I.V., 1x only, will be given 48-72 hours before each vaccine, with an antiemetic of the provider's choice (steroids prohibited).
Vaccine Day Standard Operating Procedures:
- Inquire regarding events of past weeks, change in medications, pain scale, ECOG scale, and review of systems.
- Check vaccine injection sites.
- Perform DTH skin test intra-dermally with the BriaVax™ parent cell line (~1e6 irradiated tumor cells). Observe about 20 minutes for acute hypersensitivity. Grade III or higher acute hypersensitivity will abort therapy.
- Inject vaccine 0.5 ml intra-dermally into thighs and upper back. Monitor patients for 60 minutes. Vital signs will be assessed and medical attention will be warranted if unstable.
Vaccine Preparation & Inoculation Regimen:
Each vaccine inoculation will be administered via intra-dermal injection at the investigational sites. Subjects will receive 15-25 x 106 viable, irradiated transfected breast tumor cells in a total volume of 2.0 ml Ringer's lactate. Tumor vaccine cells will be irradiated to ensure cell replication incompetency.
Vaccine will be divided into four aliquots of 0.5 ml each and prepared with coded study labels "Investigational Use Only", and hand-delivered by qualified sponsor's staff to the principal investigator's office on the day of the scheduled inoculation, where it will be injected intra-dermally; one each into the anterior skin of the subject's right and left thighs and over the right and left upper back . Application of anesthetic lidocaine crème may be used if necessary for control of local pain before inoculation. Subjects will be monitored for 60 minutes.
After at least 9 subjects have been treated safely with this regimen, the dose of BriaVax™ may be escalated or decreased in subsequent patients based on the emerging data.
48 hours (±24 hours) after vaccine, and again 96 hours (±24 hours) later after vaccine, the patient will return to the principal investigator's office to receive Interferon-alpha-2b (Merck) in 0.1 ml saline, prepared as follows: These will also be provided by the sponsor in individual syringes with coded labels, and injected intra-dermally to each vaccine site, beneath the thickest area. Again, subjects will be observed about 20 minutes. The DTH response will also be recorded in the EDC at the 48 hour (±24 hours) visit.
This vaccine cycle will be performed every 2 weeks for the first month of treatment (3 vaccinations), and then every month for up to one year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03066947
|Contact: Karen Arrington, RN BSN CCRPfirstname.lastname@example.org|
|Contact: George E Peoples, MD, FACSemail@example.com|
|United States, California|
|St. Joseph Heritage Healthcare||Recruiting|
|Santa Rosa, California, United States, 95403|
|Contact: Jennafer Carlin-Rosset, MPH 707-521-3830 Jennafer.Carlin@stjoe.org|
|Contact: Kim Young, RN, CCRC 707-521-3830 Kimberly.Young@stjoe.org|
|Principal Investigator: Jarrod P Holmes, MD|
|Study Director:||George E Peoples, MD, FACS||Cancer Insight, LLC|