Clinical trial · Interventional
DC Vaccine for Patients With Ductal Carcinoma In Situ
A Randomized Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
NCT02061332CI-TRIAL-00044608DCIS6completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HER-2 Pulsed Dendritic cell Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Intranodal Vaccine
- description
- An ultrasound device (probe) will be placed over the area of the groin or armpit. The vaccine needle will then be placed under the probe, and guided by the ultrasound machine to the groin lymph nodes or axillary nodes. You will be given a HER-2 pulsed dendritic cell vaccine in two different groin lymph nodes or axillary nodes per visit. Each dose will consist of 1.0-2.0 x 107 cells and will be injected into 1-2 different groin lymph nodes or axillary nodes.
- interventionNames
- Biological: HER-2 Pulsed Dendritic cell Vaccine
- type
- EXPERIMENTAL
- label
- Intralesional Vaccine
- description
- The HER-2 pulsed dendritic cell vaccine will be directly injected into the quadrant of the breast affected with DCIS. The location will be determined by referring to the patient's mammogram. Each dose will consist of 1.0-2.0 x 107 cells and will be injected into the quadrant of the breast affected with DCIS.
- interventionNames
- Biological: HER-2 Pulsed Dendritic cell Vaccine
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDCzerniecki 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. doi: 10.1158/0008-5472.CAN-07-0878. PMID 17638860
- BACKGROUNDCzerniecki 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. doi: 10.1158/0008-5472.CAN-06-4038. Epub 2007 Feb 9. PMID 17293384
- BACKGROUNDKoski 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. PMID 22130160
- BACKGROUNDSharma 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. PMID 22252842