Breast Cancer Clinical Trial
— DCIS6Official title:
A Randomized Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
Verified date | April 2020 |
Source | Abramson Cancer Center of the University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Women who are diagnosed with Her-2/neu over-expressing DCIS will receive DC1 vaccines by intranodal, intralesional, or both routes of administration. The primary objective will be safety and administration with secondary objectives of immune activation and clinical response.
Status | Completed |
Enrollment | 58 |
Est. completion date | October 7, 2015 |
Est. primary completion date | August 8, 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age > 18 years. - Subjects with biopsy-proven DCIS, DCIS with microinvasion, DCIS with invasive disease under 5 mm, or Paget's Disease of the nipple (DCIS of the nipple) who have not yet received definitive treatment. - HER-2/neu positive tumor as determined by >5% of tumor population expressing this marker by immunohistochemical staining 2+ using anti-HER-2/neu verified by Dr. Paul Zhang in the Department of Pathology. - Women of childbearing age with a negative pregnancy test documented prior to enrollment. - Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D). - Subjects willing to use birth control if necessary - Subjects who have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them. Exclusion Criteria: - Pregnant or lactating females (pregnancy testing to be performed within 7 days prior to administration of first dose of vaccine). - Subjects who have had a complete excisional biopsy of their tumor. - Subjects with suspicion of invasive disease > 5mm by MRI performed within 2 months of study recruitment. - Screen and exclude subjects with positive HIV or hepatitis C at baseline. - Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec - Subjects with major cardiac illness MUGA < 50% EF. - Subjects with pre-existing medical illnesses or medications which might interfere with the study. - Subjects with laboratory tests reflecting ¬> grade 1 toxicity by NCI CTC version 3.0 including CBC, liver function tests, urinalysis, EKG if cannot be corrected on repeat test in 7 days. |
Country | Name | City | State |
---|---|---|---|
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center of the University of Pennsylvania |
United States,
Czerniecki BJ, Koski GK, Koldovsky U, Xu S, Cohen PA, Mick R, Nisenbaum H, Pasha T, Xu M, Fox KR, Weinstein S, Orel SG, Vonderheide R, Coukos G, DeMichele A, Araujo L, Spitz FR, Rosen M, Levine BL, June C, Zhang PJ. Targeting HER-2/neu in early breast cancer development using dendritic cells with staged interleukin-12 burst secretion. Cancer Res. 2007 Feb 15;67(4):1842-52. Epub 2007 Feb 9. — View Citation
Czerniecki BJ, Roses RE, Koski GK. Development of vaccines for high-risk ductal carcinoma in situ of the breast. Cancer Res. 2007 Jul 15;67(14):6531-4. Review. — View Citation
Koski GK, Koldovsky U, Xu S, Mick R, Sharma A, Fitzpatrick E, Weinstein S, Nisenbaum H, Levine BL, Fox K, Zhang P, Czerniecki BJ. A novel dendritic cell-based immunization approach for the induction of durable Th1-polarized anti-HER-2/neu responses in women with early breast cancer. J Immunother. 2012 Jan;35(1):54-65. doi: 10.1097/CJI.0b013e318235f512. — View Citation
Sharma A, Koldovsky U, Xu S, Mick R, Roses R, Fitzpatrick E, Weinstein S, Nisenbaum H, Levine BL, Fox K, Zhang P, Koski G, Czerniecki BJ. HER-2 pulsed dendritic cell vaccine can eliminate HER-2 expression and impact ductal carcinoma in situ. Cancer. 2012 Sep 1;118(17):4354-62. doi: 10.1002/cncr.26734. Epub 2012 Jan 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Pressure | Blood pressure will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given. | up to 60 minutes post vaccine | |
Primary | Temperature | Temperature will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given. | up to 60 minutes post vaccine | |
Primary | Pulse | Pulse will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given. | up to 60 minutes post vaccine | |
Secondary | Immune Response | Subjects will undergo leukapheresis after completion of 6 vaccines and 3 boost vaccines for the purpose of obtaining lymphocytes and monocytes for in vitro immunologic testing. | 6-8 weeks | |
Secondary | Mammogram | All subjects will have a post-vaccine bilateral mammogram to evaluate response to vaccination. Mammograms will be performed within two weeks after the 6th vaccination. | 6-8 weeks | |
Secondary | MRI | All subjects will have a post-vaccine bilateral breast MRI to evaluate response to vaccination. MRIs will be performed within two weeks after the 6th vaccination. | 6-8 weeks |
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