DC Vaccine for Patients With Ductal Carcinoma In Situ

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer, DCIS

In brief

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.

Key facts

Study ID

NCT02061332

Run by

Abramson Cancer Center at Penn Medicine

People needed

58

Starts

2009-07-01

Expected to finish

2015-10-07

Last updated by the study team

2020-04-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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