This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.
For the extension cohort to be conducted at the IUSCCC (N=12), patients with histologically documented metastatic or unresectable breast or gastrointestinal cancer will be enrolled.
For the expansion cohort (N=30), patients with either histologically documented metastatic or unresectable breast cancer (N=15), or histologically documented metastatic or unresectable gastrointestinal cancer (N=15) be enrolled. All patients enrolled to this cohort are required to have measurable disease. Note: Measurable disease is defined as ≥ 1 lesions that can be accurately measured in ≥ 1 dimensions as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.
Patients must have received or refused first line standard systemic therapy for their metastases (if applicable) and patients with histologically confirmed pancreatic and esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years after standard therapy. Patients with histologically confirmed breast, and gastrointestinal cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years after standard therapy.
Progressive disease after at least one line of standard therapy.
Patients with tumors that are negative for HER-2 expression based on IHC of 0 AND Fluorescence in-situ hybridization showing lack of HER-2 amplification based on most recent ASCO/CAP guidelines; or are under-expressing EGFR based on FISH and IHC.
Patients on targeted therapies, such as Cycline Dependent Kinase (CDK) 4/6 or mammalian target of rapamycin (mTOR) inhibitors in combination with endocrine therapy
Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.
Patients who have evidence of active infection that requires antibiotic therapy. Patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection.
Parallel
Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720
Biological/VaccineThree intramuscular (IM) injections (separated by 21 days) of a mixture of two peptides {MVF-HER-2(597-626) and MVF-HER-2 (266-296)} vaccine emulsified in ISA 720 vehicle. The combined vaccine preparation consists of 1.5mg of each of the HER-2 vaccine emulsified with a Montanide ISA 720, and will be administered in a final volume of 1.0 ml. Patients may also receive 6 months booster shots.
Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 4.0
Humoral Immune Response
Humoral immune response will be measured by ELISA quantification of IgM and IgG antibodies to HER2 (597-626) and HER2 (266-296)
Overall Response Rate
immunogenicity
ELISA will be analyzed for immunogenicity at baseline, with every vaccine, 21 days after the final vaccine, 6 months from initial vaccination, and at 1 year from initial vaccination to describe time course of antibody production
T cell functionality
T cell functionality will be determined using proteomic profiling and immunophenotyping
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Pravin T.P Kaumaya
Lead sponsor
Indiana University
Sponsor institution
