Clinical trial development in cancer vaccines

  • Khleif, Samir N. (PI)

Project: Research project

Project Details


Assessing the role of a mutant ras peptide-based vaccine as adjuvant immunotherapy in patients with solid tumors: We developed a Quantitative real-time PCR assay as novel method to test class II responses on this protocol to check the patients' samples. We found on this trial that it is feasible to vaccinate patients with pancreatic and colon cancer on an adjuvant basis. We demonstrated in this phase II study the generation of specific immunological responses and an indication of better DFS and OS of this population than after standard therapy. (Manuscript in review)) Vaccine against the P53 antigen: In collaboration with Gynecologic Oncology Group and Dr. Theresa Whiteside at University of Pittsburgh, we have completed a clinical trial to test vaccinating patients with low burden ovarian cancer with a wild type HLA-A2 p53 epitope. We found for the first time that the majority of patients with tumor that overexpress p53 can generate specific immune responses against the antigen. In this trial we are also comparing 2 strategies for peptide delivery methods: subcutaneous vs. intravenous (manuscript will be submitted in Octobetr). Vaccine against HPV:In collaboration with the Gynecologic Oncology Group, we have just completed a clinical trial in advanced cervical cancer patients. These patients were vaccinated with either E6 or E7 peptides. We found that it is feasible to vaccinate this group of heavily pretreated patients with peptides and they can efficiently generate immune responses against the HPV antigens. The immunological testing on the rest of the patients is expected to be completed very soon. (2 manuscripts will be submitted for publication in October).Vaccine against angiogenesis:Based on our preclinical data that we generated in the lab, we are developing a protocol to vaccinate advanced renal cancer patients with HLA-A2 VEGFR2 peptides. This will be the first study in human targeting angiogenesis in a vaccine strategy.
StatusNot started


  • National Institutes of Health: $415,410.00
  • National Institutes of Health: $370,775.00
  • National Institutes of Health: $367,265.00
  • National Institutes of Health: $199,105.00
  • National Institutes of Health: $398,219.00
  • National Institutes of Health: $193,479.00


  • Medicine(all)


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