SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03066947|
Recruitment Status : Enrolling by invitation
First Posted : March 1, 2017
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breastcancer Breast Neoplasm||Biological: SV-BR-1-GM Drug: Cyclophosphamide Biological: Interferon-alpha-2b||Phase 1 Phase 2|
This is a single arm, open label study of SV-BR-1-GM in recurrent and/or metastatic breast cancer. The detailed treatment regimen follows:
Cyclophosphamide (Cytoxan) 300 mg/m^2 I.V., 1x only, will be given 48-72 hours before each SV-BR-1-GM inoculation, with an antiemetic of the provider's choice (steroids prohibited). If the patient is not tolerating the cyclophosphamide, a lower dose may be used (e.g. 200 or 150 mg/m^2) or it may be withheld, with the Sponsor's approval.
Innoculation Day Standard Operating Procedures:
- Inquire regarding events of past weeks, change in medications, pain scale, ECOG scale, and review of systems.
- Check injection sites.
- Perform DTH skin test intra-dermally with the SV-BR-1 parent cell line (~1 x 10^6 irradiated tumor cells). Observe about 20 minutes for acute hypersensitivity. Grade III or higher acute hypersensitivity will abort therapy.
- Inject SV-BR-1-GM intra-dermally into 4 sites in thighs and upper back (0.5 mL each). Monitor patients for 60 minutes. Vital signs will be assessed and medical attention will be warranted if unstable.
SV-BR-1-GM Preparation & Inoculation Regimen:
Each inoculation will be administered via intra-dermal injection at the investigational sites. Subjects will receive 15-25 x 10^6 viable, irradiated transfected breast tumor cells in a total volume of 2.0 ml Ringer's lactate. SV-BR-1-GM cells will be irradiated to ensure cell replication incompetency.
SV-BR-1-GM will be divided into four aliquots of 0.5 mL each and 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 10 subjects have been treated safely with this regimen, the dose of SV-BR-1-GM may be escalated or decreased in subsequent patients based on the emerging data.
2 days (± 1 day) after inoculation, and again 4 days (± 1 day) later after inoculation, 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 and injected intra-dermally to each inoculation site, beneath the thickest area. Again, subjects will be observed about 20 minutes. The DTH response will also be recorded at the 2 days (± 1 day) visit.
This cycle will be performed every 2 weeks for the first month of treatment (3 inoculations), and then every month for up to one year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients|
|Actual Study Start Date :||May 5, 2017|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||March 2019|
Experimental: SV-BR-1-GM Monotherapy
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM 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 SV-BR-1-GM inoculation
Low dose pre-treatment to reduce regulatory T cells
Other Name: Cytoxan
Low dose given in the vaccine site to boost the immune response
Other Name: Intron A
- 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 SV-BR-1-GM, 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 SV-BR-1-GM, as defined by CTCAE
- Relationship of Adverse Events to SV-BR-1-GM [Safety] [ Time Frame: Through study completion, an average of 1 year ]To evaluate the relationship of toxicity events, as defined by CTCAE, to SV-BR-1-GM 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 response evaluation criteria in solid tumors (RECIST) and immune-related RECIST (iRECIST) criteria.
- 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 RECIST and iRECIST criteria
- 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 SV-BR-1-GM, 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066947
|United States, California|
|St. Joseph Heritage Healthcare|
|Santa Rosa, California, United States, 95403|
|United States, Florida|
|University of Miami/Sylvester at Plantation|
|Plantation, Florida, United States, 33324|
|United States, Kansas|
|Cancer Center of Kansas (CCK)|
|Wichita, Kansas, United States, 67214|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Washington|
|Providence Regional Medical Center|
|Everett, Washington, United States, 98201|
|Study Director:||George E Peoples, MD, FACS||Cancer Insight, LLC|