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This phase II trial tests how well pB1-11 and human papillomavirus tumor antigen (TA-HPV) vaccines in combination with pembrolizumab work in treating patients with oropharyngeal cancer that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) and that is PD-L1 and human papillomavirus (HPV) positive. Oropharyngeal cancer is a type of head and neck cancer involving structures in the back of the throat (the oropharynx), such as the non-bony back roof of the mouth (soft palate), sides and back wall of the throat, tonsils, and back third of the tongue. Scientists have found that some strains or types of a virus called HPV can cause oropharyngeal cancer. pBI-11 is a circular deoxyribonucleic acid (DNA) (plasmid) vaccine that promotes antibody, cytotoxic T cell, and protective immune responses. TA-HPV is an investigational recombinant vaccina virus derived from a strain of the vaccina virus which was widely used for smallpox vaccination. Vaccination with this TA-HPV vaccine may stimulate the immune system to mount a cytotoxic T cell response against tumor cells positive for HPV, resulting in decreased tumor growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread by inhibiting the PD-1 receptor. These investigational vaccines could cause or enhance an immune response in the body against HPV, during which time the activity of pembrolizumab against oropharyngeal cancer associated with HPV may be strengthened. These drugs in combination may be more effective in increasing the ability of the immune system to fight oropharyngeal cancer than pembrolizumab alone.

Paula Gonzalez Ericsson, M.D.

  • Senior Staff Scientist

Phone

(615)343-7993

Email

paula.i.gonzalez.ericsson@vumc.org
220 Pierce Ave.
Nashville, TN 37232

Paula Gonzalez Ericsson, M.D.

  • Senior Staff Scientist

(615)343-7993

paula.i.gonzalez.ericsson@vumc.org

220 Pierce Ave.
Nashville, TN 37232

Research Program

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This phase II trial studies how well talazoparib works for the treatment of breast cancer with a BRCA 1 or BRCA 2 gene mutation that has spread to other places in the body (metastatic). Talazoparib is a study drug that inhibits (stops) the normal activity of certain proteins called poly (ADP-ribose) polymerases also called PARPs. PARPs are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as talazoparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. PARPs are needed to repair mistakes that can happen in DNA when cells divide. If the mistakes are not repaired, the defective cell will usually die and be replaced. Cells with mistakes in their DNA that do not die can become tumor cells. Tumor cells may be killed by a study drug, like talazoparib, that stops the normal activity of PARPs. Talazoparib may be effective in the treatment of metastatic breast cancer with BRCA1 or BRCA2 mutations.
This phase III trial compares the effect of radiation therapy combined with hormonal therapy versus hormonal therapy alone in treating patients with low risk, early stage breast cancer with Oncotype Dx Recurrence = 18. Oncotype DX is a laboratory test which results in a score that is used to help predict whether breast cancer will spread to other parts of the body or come back. Radiation therapy uses high doses of radiation to kill cancer cells and shrink tumors but may result in some side effects. Hormones called estrogen and progesterone may contribute to the growth of breast tumor cells. Hormone therapy, also called endocrine therapy, may stop the growth of tumor cells by blocking or removing these hormones. This clinical trial may help researchers understand if patients with low-risk, early stage breast cancer who have Oncotype recurrence score of = 18 can safely omit radiation therapy and only be treated with hormonal therapy without losing any radiation treatment benefit.
This phase I trial evaluates the usefulness of an imaging agent (zirconium Zr 89 panitumumab [89Zr panitumumab]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing primary tumors and/or the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. 89Zr panitumumab is an investigational imaging agent that contains a small amount of radiation, which makes it visible on PET scans. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr panitumumab, to allow imaging of the function of different cells and organs in the body. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential disease tissue where it occurs in patients body. The combined PET/CT scanner is a special type of scanner that allows imaging of both structure (CT) and function (PET) following the injection of 89Zr panitumumab. This 89Zr panitumumab PET/CT may be useful in diagnosis of primary tumors and/or metastasis in patients with head and neck squamous cell carcinoma.

An Imaging Agent (Panitumumab-IRDye800) for the Detection of Head and Neck Cancer During Surgery

This phase II trial studies the effect of panitumumab-IRDye800 in detecting head and neck cancer during surgery in patients head and neck cancer. Doctors who perform surgery for head and neck cancer are well-trained in removing all of the cancer that can be seen during the operation; however, there are times when there is cancer that is so small that it cannot be seen by the surgeon. Panitumumab-IRDye800 is a combination of panitumumab and IRDye800CW. Panitumumab works by attaching to the cancer cell in a unique way that allows the drug to get into the cancer tissue. IRDye800CW is an investigational dye that, when tested in the laboratory, helps various characteristics of human tissue show up better when using a special camera. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during the surgery. Giving panitumumab-IRDye800 may help doctors better identify cancer in the operating room.

Capecitabine Compared to Endocrine Therapy for the Treatment of Non-luminal A Hormone Receptor-Positive Metastatic Breast Cancer

This phase II trial compares the effect of capecitabine to endocrine therapy in patients with non-Luminal A hormone receptor-positive breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). In this study, patients submit a sample of tumor for testing to determine if their breast cancer is considered non-Luminal A. Only patients with non-Luminal A receive study treatment. In the future, doctors hope that this test can assist in picking the best treatment for patients with this type of cancer. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Endocrine therapy is treatment that adds, blocks, or removes hormones. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body's natural hormones. Giving capecitabine as compared to endocrine therapy may kill more tumor cells in patients with metastatic breast cancer.

Mismatched Related Donor versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults with Acute Leukemia or Myelodysplastic Syndrome

This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical [haplo]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is or if a haplo related donor or MUD is better. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all.

Vincristine Pharmacokinetics in Infants

This pilot trial compares drug exposure levels using a new method for dosing vincristine in infants and young children compared to the standard dosing method based on body surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety of childhood cancers. The doses anticancer drugs in children must be adjusted based on the size of the child because children vary significantly in size (height, weight, and BSA) and ability to metabolize drugs from infancy to adolescence. The dose of most anticancer drugs is adjusted to BSA, which is calculated from a patients weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so new dosing models have to be made to safely give anticancer drugs to the youngest patients. This new method uses a BSA-banded approach to determine the dose. Collecting blood samples before and after a dose of the drug will help researchers determine whether this new vincristine dosing method results in equivalent drug levels in the blood over time in infants and young children compared to older children.
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NCCN National Comprehensive Cancer Network
NCI National Clinical Trials Network