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Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer
Phase 1, PHASE2 trial testing autologous dendritic cell-adenovirus p53 vaccine in Breast Cancer in 24 participants. Completed in 1 January 2018.
| Lead sponsor | University of Nebraska |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 January 2004 |
| Primary completion | 1 May 2009 |
| Estimated completion | 1 January 2018 |
| Sites | 1 location across United States |
University of Nebraska
Adults 19 to 120, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
This outcome measure looks at the safety of the vaccine by documenting the number of grade 2, 3, or toxicities experienced by participants related to the vaccine.
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 0 | |
| Arm II | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 100 | |
| Arm II | 53 |
This outcome measure examined the importance of vaccine timing on antigen-specific relative to the primary cytotoxic therapy on the augmentation of antigen specific immune responses by measuring the duration of immune responses of participants
| Group | Value | 95% CI |
|---|---|---|
| Arm I - Early Vaccine and Arm II - Late Vaccine Administration | 8.54 | 0.09 – 32.5 |
Time frame: Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm I | Arm II |
|---|---|---|---|
| Confusion | Psychiatric disorders | — | — |
| Fever | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| skin infection | Infections and infestations | — | — |
| Hip fracture | Injury, poisoning and procedural complications | — | — |
| Reaction | System | Arm I | Arm II |
|---|---|---|---|
| neutrophil count decreased | Investigations | — | — |
| white blood cell decreased | Investigations | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| anemia | Blood and lymphatic system disorders | — | — |
| platelet count decreased | Investigations | — | — |
| Lung infection | Infections and infestations | — | — |
| hyperglycemia | Metabolism and nutrition disorders | — | — |
| Pain | General disorders | — | — |
| depression | Psychiatric disorders | — | — |
| constipation | Gastrointestinal disorders | — | — |
| hypocalcemia | Metabolism and nutrition disorders | — | — |
| hypokalemia | Metabolism and nutrition disorders | — | — |
| vomiting | Gastrointestinal disorders | — | — |
| rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| mucositis oral | Gastrointestinal disorders | — | — |
| urinary tract infection | Infections and infestations | — | — |
| urinary incontinence | Renal and urinary disorders | — | — |
| peripheral sensory neuropathy | Nervous system disorders | — | — |
| hypertension | Vascular disorders | — | — |
| skin infection | Infections and infestations | — | — |
| syncope | Nervous system disorders | — | — |
| sepsis | Infections and infestations | — | — |
Most-reported serious reactions: Confusion, Fever, Nausea, Vomiting, skin infection, Hip fracture.
Data from ClinicalTrials.gov NCT00082641 adverse events section.
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy before and/or after chemotherapy and radiation therapy may cause a stronger immune response. PURPOSE: This randomized phase I/II trial is studying the side effects of two regimens of vaccine therapy and to see how well they work in treating women who are receiving neoadjuvant or adjuvant chemotherapy and adjuvant radiation therapy for stage III breast cancer that overexpresses p53.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00082641.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing