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4. Pertuzumab Plus Trastuzumab in Patients With Biliary Tract Cancer With ERBB2/3 Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Author

Cannon, Timothy L., Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Chiu, Vi K., Hwang, Jimmy, Vijayvergia, Namrata, Alese, Olatunji B., Dib, Elie G., Duvivier, Herbert L., Klute, Kelsey A., Sahai, Vaibhav, Ahn, Eugene R., Bedano, Pablo, Behl, Deepti, Sinclair, Sarah, Thota, Ramya, Urba, Walter J., Yang, Eddy S., and Grantham, Gina N.

Published
2024
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5. Cobimetinib Plus Vemurafenib in Patients With Solid Tumors With BRAF Mutations: Results From the Targeted Agent and Profiling Utilization Registry Study

Author

Meric-Bernstam, Funda, Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Gutierrez, Rodolfo, Ahn, Eugene R., Cannon, Timothy L., Powell, Steven, Krauss, John C., Reynolds, Christopher M., von Mehren, Margaret, Behl, Deepti, Calfa, Carmen J., Duvivier, Herbert L., Kaplan, Henry G., Livingston, Michael B., Sharma, Manish R., Urba, Walter J., Grantham, Gina N., Hinshaw, Dominique C., Gregory, Abigail, Halabi, Susan, and Schilsky, Richard L.

Published
2023
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6. Cetuximab in Patients with Breast Cancer, Non-Small Cell Lung Cancer, and Ovarian Cancer Without KRAS, NRAS, or BRAF Mutations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Fisher, Julie G., Tait, David, Garrett-Mayer, Elizabeth, Halabi, Susan, Mangat, Pam K., Schink, Julian C., Alvarez, Ricardo H., Veljovich, Dan, Cannon, Timothy L., Crilley, Pamela A., Pollock, Theodore, Calfa, Carmen J., Al Baghdadi, Tareq, Thota, Ramya, Fleming, Nicole, Cotta, Jared A., Rygiel, Andrew L., Warren, Sasha L., and Schilsky, Richard L.

Published
2020
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7. Cobimetinib Plus Vemurafenib in Patients With Colorectal Cancer With BRAF Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Klute, Kelsey A., Rothe, Michael, Garrett-Mayer, Elizabeth, Mangat, Pam K., Nazemzadeh, Reza, Yost, Kathleen J., Duvivier, Herbert L., Ahn, Eugene R., Cannon, Timothy L., Alese, Olatunji B., Krauss, John C., Thota, Ramya, Calfa, Carmen J., Denlinger, Crystal S., OʼLone, Raegan, Halabi, Susan, Grantham, Gina N., and Schilsky, Richard L.

Published
2022
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8. Pembrolizumab in Patients With Tumors With High Tumor Mutational Burden: Results From the Targeted Agent and Profiling Utilization Registry Study

Author

Duvivier, Herbert L., primary, Rothe, Michael, additional, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Ahn, Eugene R., additional, Al Baghdadi, Tareq, additional, Alva, Ajjai S., additional, Dublis, Stephanie A., additional, Cannon, Timothy L., additional, Calfa, Carmen J., additional, Li, Rui, additional, Behl, Deepti, additional, Chiu, Vi K., additional, Gold, Philip J., additional, Marr, Alissa S., additional, Mileham, Kathryn F., additional, Powell, Steven Francis, additional, Rodon, Jordi, additional, Thota, Ramya, additional, Grantham, Gina N., additional, Gregory, Abigail, additional, Hinshaw, Dominique C., additional, Halabi, Susan, additional, and Schilsky, Richard L., additional

Published
2023
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9. Integration of Multi-omic Data in a Molecular Tumor Board Reveals EGFR-Associated ALK-Inhibitor Resistance in a Patient With Inflammatory Myofibroblastic Cancer

Author

Hunt, Allison L, primary, Nutcharoen, Aratara, additional, Randall, Jamie, additional, Papazian, Alyssa, additional, Deeken, John, additional, Maxwell, G Larry, additional, Bateman, Nicholas W, additional, Petricoin, Emanuel F, additional, Benyounes, Amin, additional, Conrads, Thomas P, additional, and Cannon, Timothy L, additional

Published
2023
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11. Remote Home Monitoring of Patients with Cancer During the COVID-19 Pandemic

Author

Steimer, Mary, primary, Leabo, Jessica, additional, Wang, Hongkun, additional, Heyer, David, additional, Bowles, Nancy, additional, Matthews, Laura, additional, Cannon, Timothy L., additional, Cuevo, Raymund, additional, Ershler, William B., additional, Shafer, Danielle, additional, Jang, Sekwon, additional, Pennisi, Angela, additional, Al-Hussain, Amjaad, additional, Farrell, Kirby, additional, and Deeken, John F., additional

Published
2022
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12. Remote Home Monitoring of Patients With Cancer During the COVID Pandemic: A Pilot Study

Author

Steimer, Mary, primary, Leabo, Jessica, additional, Wang, Hongkun, additional, Heyer, David, additional, Addison, Nancy, additional, Bowles, Nancy, additional, Cannon, Timothy L., additional, Cuevo, Raymund, additional, Ershler, William B., additional, Shafer, Danielle, additional, Jang, Sekwon, additional, Pennisi, Angela, additional, Al-Hussain, Amjaad, additional, Farrell, Kirby, additional, and Deeken, John F., additional

Published
2021
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13. Pembrolizumab in Patients With Metastatic Breast Cancer With High Tumor Mutational Burden: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Alva, Ajjai S., primary, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Halabi, Susan, additional, Hansra, Damien, additional, Calfa, Carmen J., additional, Khalil, Maged F., additional, Ahn, Eugene R., additional, Cannon, Timothy L., additional, Crilley, Pamela, additional, Fisher, Julie G., additional, Haslem, Derrick S., additional, Shrestha, Sagun, additional, Antonelli, Kaitlyn R., additional, Butler, Nicole L., additional, Warren, Sasha L., additional, Rygiel, Andrew L., additional, Ranasinghe, Shamika, additional, Bruinooge, Suanna S., additional, and Schilsky, Richard L., additional

Published
2021
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14. American Society of Clinical Oncology Road to Recovery Report: Learning From the COVID-19 Experience to Improve Clinical Research and Cancer Care

Author

Pennell, Nathan A., primary, Dillmon, Melissa, additional, Levit, Laura A., additional, Moushey, E. Allyn, additional, Alva, Ajjai S., additional, Blau, Sibel, additional, Cannon, Timothy L., additional, Dickson, Natalie R., additional, Diehn, Maximilian, additional, Gonen, Mithat, additional, Gonzalez, Maria Magdalena, additional, Hensold, Jack O., additional, Hinyard, Leslie J., additional, King, Tari, additional, Lindsey, Stacie C., additional, Magnuson, Allison, additional, Marron, Jonathan, additional, McAneny, Barbara L., additional, McDonnell, Theresa M., additional, Mileham, Kathryn Finch, additional, Nasso, Shelley Fuld, additional, Nowakowski, Grzegorz S., additional, Oettel, Kurt R., additional, Patel, Manali I., additional, Patt, Debra A., additional, Perlmutter, Jane, additional, Pickard, Todd A., additional, Rodriguez, Gladys, additional, Rosenberg, Abby R., additional, Russo, Barry, additional, Szczepanek, Connie, additional, Smith, Cardinale B., additional, Srivastava, Piyush, additional, Teplinsky, Eleonora, additional, Thota, Ramya, additional, Traina, Tiffany A., additional, Zon, Robin, additional, Bourbeau, Brian, additional, Bruinooge, Suanna S., additional, Foster, Shelagh, additional, Grubbs, Stephen, additional, Hagerty, Karen, additional, Hurley, Patricia, additional, Kamin, Deborah, additional, Phillips, Jonathan, additional, Schenkel, Caroline, additional, Schilsky, Richard L., additional, and Burris, Howard A., additional

Published
2021
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16. Palbociclib in Patients With Non–Small-Cell Lung Cancer With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study

Author

Ahn, Eugene R., primary, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Halabi, Susan, additional, Dib, Elie G., additional, Haggstrom, Daniel E., additional, Alguire, Kathryn B., additional, Calfa, Carmen J., additional, Cannon, Timothy L., additional, Crilley, Pamela A., additional, Gaba, Anu G., additional, Marr, Alissa S., additional, Sangal, Ashish, additional, Thota, Ramya, additional, Antonelli, Kaitlyn R., additional, Islam, Samiha, additional, Rygiel, Andrew L., additional, Bruinooge, Suanna S., additional, and Schilsky, Richard L., additional

Published
2020
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19. Abstract CT135: Cetuximab (C) in patients (Pts) with breast cancer (BC) and non-small cell lung cancer (NSCLC) without reported KRAS, NRAS, BRAF mutations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Fisher, Julie, primary, Garrett-Mayer, Elizabeth, additional, Halabi, Susan, additional, Mangat, Pam K., additional, Alvarez, Ricardo H., additional, Cannon, Timothy L., additional, Crilley, Pamela, additional, Pollock, Theodore, additional, Baghdadi, Tareq Al, additional, Cotta, Jared A., additional, Rygiel, Andrew L., additional, Antonelli, Kaitlyn R., additional, Islam, Samiha, additional, Bruinooge, Suanna S., additional, and Schilsky, Richard L., additional

Published
2019
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20. Abstract CT135: Cetuximab (C) in patients (Pts) with breast cancer (BC) and non-small cell lung cancer (NSCLC) without reportedKRAS, NRAS, BRAFmutations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Fisher, Julie, primary, Garrett-Mayer, Elizabeth, additional, Halabi, Susan, additional, Mangat, Pam K., additional, Alvarez, Ricardo H., additional, Cannon, Timothy L., additional, Crilley, Pamela, additional, Pollock, Theodore, additional, Baghdadi, Tareq Al, additional, Cotta, Jared A., additional, Rygiel, Andrew L., additional, Antonelli, Kaitlyn R., additional, Islam, Samiha, additional, Bruinooge, Suanna S., additional, and Schilsky, Richard L., additional

Published
2019
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26. Immune Interference After Sequential Alphavirus Vaccine Vaccinations

Author

ARMY MEDICAL RESEARCH INST OF INFECTIOUS DISEASES FORT DETRICK MD, Pittman, Phillip R., Liu, Ching-Tong, Cannon, Timothy L., Mangiafico, Joseph A., Gibbs, Paul H., ARMY MEDICAL RESEARCH INST OF INFECTIOUS DISEASES FORT DETRICK MD, Pittman, Phillip R., Liu, Ching-Tong, Cannon, Timothy L., Mangiafico, Joseph A., and Gibbs, Paul H.

Abstract

We compared the effect of order of administration of investigational alphavirus vaccines on neutralizing antibody response. Volunteers who received the inactivated eastern and western equine encephalitis (EEE and WEE) vaccines before live attenuated Venezuelan (VEE) vaccine had significantly lower rates of antibody response than those receiving VEE vaccine before EEE and WEE vaccines (66.7% vs. 80.6%; p=0.026). The odds of having a VEE antibody non-response among those initially receiving EEE and WEE vaccines, adjusted for gender, were significant (odds ratio [OR]=2.20; 95% CI=1.2-4.1 [p=0.0145]) as were the odds of non-response among females adjusted for group (OR=1.81; 95% CI=1.2-2.7 [p=0.0037]). Antibody interference and gender effect have major implications for vaccine strategy among those receiving multiple alphavirus vaccines and those developing next generation vaccines for these threats., The original document contains color images. Pub. in Vaccine, v27 p4879-4882, 2009.

Published
2009

29. Long-Term Health Effects of Repeated Exposure to Multiple Vaccines

Author

ARMY MEDICAL RESEARCH INST OF INFECTIOUS DISEASES FORT DETRICK MD, Pittman, Phillip R., Coonan, Kevin M., Gibbs, Paul H., Scott, Helen M., Cannon, Timothy L., ARMY MEDICAL RESEARCH INST OF INFECTIOUS DISEASES FORT DETRICK MD, Pittman, Phillip R., Coonan, Kevin M., Gibbs, Paul H., Scott, Helen M., and Cannon, Timothy L.

Abstract

The health of 155 former workers in a US military research program who had received multiple vaccines and 265 matched community controls was assessed. The study population was mostly male (83%) and elderly (median age, 69 years). Multiple immunized (MIP) subjects received vaccines and/or skin tests (median = 154) over a median of 17.3 years; interval from start of immunizations to survey completion was 15-55 years (mean = 43.1 years). MIP subjects characterized themselves as slightly less healthy than controls (P = 0.057). Fatigue (but no other symptom) was reported more frequently in the MIP group (P = 0.011), but was not associated with number of injections, number of vaccines, or time in program. No differences between MIP and control groups were seen for numerous self-reported medical conditions. Several statistically significant abnormalities were seen in clinical laboratory tests among MIP subjects, but none appeared to be clinically significant. A significant difference in frequency of monoclonal spikes and/or paraprotein peaks between MIP (12.5%) and control (4.5%) groups (RR = 2.7, P < 0.003) was observed; no associations with lifestyle, vaccine exposure, or medical conditions were found., Pub. in Vaccine v23 n4 p525-536, 2004. The original document contains color images.

Published
2004

33. An Automated Data Management System for Remote Medical Studies

Author

Oland, Dwayne D., Feuillade, Maria Rosa, Warren, David M., and Cannon, Timothy L.

Subjects
Research Systems
Abstract

Effective verification, analysis and management of medical research data in remote sites create a unique challenge for members of the research community. The recent use of microcomputer hardware and software has eliminated many data management problems, but it is difficult to implement this technology at remote sites with small staffs who have little familiarity with computers. An automated data management system, which utilizes a portable microcomputer, a small optical mark reader and commercially available software, eliminates many data entry and verification problems by allowing direct data entry from full page forms into the microcomputer without keyboard entry. The elimination of manual data entry allows the local staff to be more productive and spend more time on quality control of the data. This system has been successfully used in clinical trials conducted in Argentina and the Peoples Republic of China and shows great promise as an effective data management tool at field-study and remote epidemiological research sites.

Published
1987

34. Reduced Survival of Adult Culex Pipiens Infected with Rift Valley Fever Virus

Author

ARMY MEDICAL RESEARCH INST OF INFECTIOUS DISEASES FORT DETRICK MD, Faran, Michael E, Turell, Michael J, Romoser, William S, Routier, Robert G, Gibbs, Paul H, Cannon, Timothy L, Bailey, Charles L, ARMY MEDICAL RESEARCH INST OF INFECTIOUS DISEASES FORT DETRICK MD, Faran, Michael E, Turell, Michael J, Romoser, William S, Routier, Robert G, Gibbs, Paul H, Cannon, Timothy L, and Bailey, Charles L

Abstract

The effect of Rift Valley fever (RVF) viral infection on the survival of female Culex pipiens was examined. In 3 experiments in which mosquitoes ingested RVF virus, there was a 44% decrease in survival to days 14-16 for transmitting vs. nontransmitting mosquitoes, and a 48% decrease in survival for individuals with disseminated vs. nondiseminated infections. These results were corroborated by other experiments in which survival of mosquitoes intrathoracically inoculated with RVF virus was compared with that of those inoculated with diluent. In both the per os and inoculation tests, uninfected mosquitoes survived significantly longer than infected mosquitoes. Even though mosquitoes with disseminated infection had a lower survival rate that did uninfected mosquitoes, dissemination and transmission rates were similar at days 7 and 14-18 after the infectious bloodmeal. This suggests that nondisseminated individuals were developing disseminated infections and becoming capable of transmitting virus between days 7 and 14-18 at approximately the same rate older transmitters were dying. The decreased survival associated with RVF viral infection should be considered in predictive models of this disease., Published in the American Journal of Tropical Medicine and Hygiene, v37 n2 p403-409, 1987.

Published
1987

36. Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of KRAS -Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial.

Author

Ahn DH, Ridinger M, Cannon TL, Mendelsohn L, Starr JS, Hubbard JM, Kasi A, Barzi A, Samuëlsz E, Karki A, Subramanian RA, Yemane D, Kim R, Wu CC, Croucher PJP, Smeal T, Kabbinavar FF, and Lenz HJ

Abstract

Purpose: This phase II study evaluated the efficacy and tolerability of onvansertib, a polo-like kinase 1 (PLK1) inhibitor, in combination with fluorouracil, leucovorin, and irinotecan (FOLFIRI) + bevacizumab for the second-line treatment of KRAS -mutant metastatic colorectal cancer (mCRC)., Patients and Methods: This multicenter, open-label, single-arm study enrolled patients with KRAS -mutated mCRC previously treated with oxaliplatin and fluorouracil with or without bevacizumab. Patients received onvansertib (15 mg/m 2 once daily on days 1-5 and 15-19 of a 28-day cycle) and FOLFIRI + bevacizumab (days 1 and 15). The primary end point was the objective response rate (ORR), and secondary endpoints included progression-free survival (PFS), duration of response (DOR), and tolerability. Translational and preclinical studies were conducted in KRAS -mutant CRC., Results: Among the 53 patients treated, the confirmed ORR was 26.4% (95% CI, 15.3 to 40.3). The median DOR was 11.7 months (95% CI, 9.4 to not reached). Grade 3/4 adverse events were reported in 62% of patients. A post hoc analysis revealed that patients with no prior bevacizumab treatment had a significantly higher ORR and longer PFS compared with patients with prior bevacizumab treatment: ORR of 76.9% versus 10.0% (odds ratio of 30.0, P < .001) and median PFS of 14.9 months versus 6.6 months (hazard ratio of 0.16, P < .001). Our translational findings support that prior bevacizumab exposure contributes to onvansertib resistance. Preclinically, we showed that onvansertib inhibited the hypoxia pathway and exhibited robust antitumor activity in combination with bevacizumab through the inhibition of angiogenesis., Conclusion: Onvansertib in combination with FOLFIRI + bevacizumab showed significant activity in the second-line treatment of patients with KRAS -mutant mCRC, particularly in patients with no prior bevacizumab treatment. These findings led to the evaluation of the combination in the first-line setting (ClinicalTrails.gov identifier: NCT06106308).

Published
2024
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37. Palbociclib in Patients With Head and Neck Cancer and Other Tumors With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Author

Worden FP, Pisick E, Rothe M, Mangat PK, Garrett-Mayer E, Khalil MF, Carrizosa DR, Bauman JR, Leidner RS, Duvivier HL, Fu S, Park MS, Yost KJ, Calfa CJ, Marr AS, Balmanoukian AS, Behl D, Cannon TL, Nabell L, Powell SF, Thota R, Hinshaw DC, Gregory A, Grantham GN, Halabi S, and Schilsky RL

Subjects
Humans, Female, Male, Middle Aged, Aged, Adult, Aged, 80 and over, Mutation, Pyridines therapeutic use, Piperazines therapeutic use, Head and Neck Neoplasms drug therapy, Head and Neck Neoplasms genetics, Cyclin-Dependent Kinase Inhibitor p16 genetics, Registries
Abstract

Purpose: Targeted Agent and Profiling Utilization Registry is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and targetable genomic alterations. Two cohorts of patients with cyclin-dependent kinase inhibitor 2A ( CDKN2A )-mutated tumors treated with palbociclib are reported: one with head and neck cancer (HNC) with both squamous and nonsquamous cell histologies, and one with histology-pooled (HP) cancers., Methods: Eligible patients had measurable disease, Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no standard treatment options. The primary end point was disease control (DC), defined as objective response (OR) or stable disease (SD) of at least 16+ weeks duration. For the HNC cohort, Simon's two-stage design with a null DC rate of 15% versus 35% (power = 0.85; α = .10) was used. For the HP cohort, the null hypothesis of a DC rate of 15% was rejected if the lower limit of a one-sided 90% CI was >15%. Secondary end points included OR, safety, progression-free survival, overall survival, duration of response, and duration of SD., Results: Seventy patients with HNC (N = 28) or HP cancers (N = 42) were treated with palbociclib. For the HNC cohort, DC and OR rates were 40% (one-sided 90% CI, 27 to 100) and 4% (95% CI, <1 to 18), respectively. The null hypothesis was rejected ( P = .002). For the HP cohort, DC and OR rates were 13% (one-sided 90% CI, 6 to 100) and 5% (95% CI, <1 to 17), respectively. The null hypothesis was not rejected. Thirty-one of 70 patients experienced treatment-related grade 3 to 4 adverse events (AEs) or serious AEs, the most common including neutropenia, thrombocytopenia, and leukopenia., Conclusion: Palbociclib met prespecified criteria to declare a signal of activity in patients with HNC with CDKN2A alterations, but not in the HP cohort.

Published
2024
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