Good news! Cancer is history (soon)!
Why do these human trials still take so many years in the 21st century! How many lives could have been saved with shorter trials?
"A new paper in the journal JAMA Oncology has reported the results of a decade-long Phase 1 human trial testing an experimental breast cancer vaccine. The novel treatment was found to be "very safe" and a larger Phase 2 trial is now underway testing efficacy. ...
These kinds of cancer vaccines are not designed to be preventative vaccines that stop cancers from appearing in the first place. Instead, these are known as therapeutic vaccines, given to patients after they are diagnosed with a cancer in the hopes they help the immune system better seek and destroy certain tumors. ...
This Phase 1 trial began 20 years ago, slowly enrolling 66 patients with advanced HER2-positive breast cancer. ..."
These kinds of cancer vaccines are not designed to be preventative vaccines that stop cancers from appearing in the first place. Instead, these are known as therapeutic vaccines, given to patients after they are diagnosed with a cancer in the hopes they help the immune system better seek and destroy certain tumors. ...
This Phase 1 trial began 20 years ago, slowly enrolling 66 patients with advanced HER2-positive breast cancer. ..."
From the abstract:
"Importance High levels of ERBB2 (formerly HER2)–specific type 1 T cells in the peripheral blood are associated with favorable clinical outcomes after trastuzumab therapy; however, only a minority of patients develop measurable ERBB2 immunity after treatment. Vaccines designed to increase ERBB2-specific T-helper cells could induce ERBB2 immunity in a majority of patients.
Objective
To determine the safety and immunogenicity of 3 doses (10, 100, and 500 μg) of a plasmid-based vaccine encoding the ERBB2 intracellular domain (ICD).
To determine the safety and immunogenicity of 3 doses (10, 100, and 500 μg) of a plasmid-based vaccine encoding the ERBB2 intracellular domain (ICD).
Design, Setting, and Participants
Single-arm phase 1 trial including 66 patients with advanced-stage ERBB2-positive breast cancer treated in an academic medical center between 2001 and 2010 with 10-year postvaccine toxicity assessments. Data analysis was performed over 2 periods: January 2012 to March 2013 and July 2021 to August 2022.
Single-arm phase 1 trial including 66 patients with advanced-stage ERBB2-positive breast cancer treated in an academic medical center between 2001 and 2010 with 10-year postvaccine toxicity assessments. Data analysis was performed over 2 periods: January 2012 to March 2013 and July 2021 to August 2022.
Interventions
Patients were sequentially enrolled to the 3 dose arms. The vaccine was administered intradermally once a month with soluble granulocyte-macrophage colony-stimulating factor as an adjuvant for 3 immunizations. Toxicity evaluations occurred at set intervals and yearly. Peripheral blood mononuclear cells were collected for evaluation of immunity. Biopsy of vaccine sites at weeks 16 and 36 measured DNA persistence.
Patients were sequentially enrolled to the 3 dose arms. The vaccine was administered intradermally once a month with soluble granulocyte-macrophage colony-stimulating factor as an adjuvant for 3 immunizations. Toxicity evaluations occurred at set intervals and yearly. Peripheral blood mononuclear cells were collected for evaluation of immunity. Biopsy of vaccine sites at weeks 16 and 36 measured DNA persistence.
Main Outcomes and Measures
Safety was graded by Common Terminology Criteria for Adverse Events, version 3.0, and ERBB2 ICD immune responses were measured by interferon-γ enzyme-linked immunosorbent spot. Secondary objectives determined if vaccine dose was associated with immunity and evaluated persistence of plasmid DNA at the vaccine site.
Results
A total of 66 patients (median [range] age, 51 [34-77] years) were enrolled. The majority of vaccine-related toxic effects were grade 1 and 2 and not significantly different between dose arms. ... ERBB2 ICD immunity at time points after the end of immunizations was significantly lower on average in patients with DNA persistence at week 16 compared with those without persistence. The highest vaccine dose was associated with the greatest incidence of persistent DNA at the injection site.
Conclusions and Relevance
In this phase 1 nonrandomized clinical trial, immunization with the 100-μg dose of the ERBB2 ICD plasmid-based vaccine was associated with generation of ERBB2-specific type 1 T cells in most patients with ERBB2-expressing breast cancer, and it is currently being evaluated in randomized phase 2 trials."
In this phase 1 nonrandomized clinical trial, immunization with the 100-μg dose of the ERBB2 ICD plasmid-based vaccine was associated with generation of ERBB2-specific type 1 T cells in most patients with ERBB2-expressing breast cancer, and it is currently being evaluated in randomized phase 2 trials."
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