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2. A framework for assessing the impact of accelerated approval

Author

Gould, A. Lawrence, primary, Campbell, Robert K., additional, Loewy, John W., additional, Beckman, Robert A., additional, Dey, Jyotirmoy, additional, Schiel, Anja, additional, Burman, Carl-Fredrik, additional, Zhou, Joey, additional, Antonijevic, Zoran, additional, Miller, Eva R., additional, and Tang, Rui, additional

Published
2022
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5. Combined immunotherapy with controlled interleukin-12 gene therapy and immune checkpoint blockade in recurrent glioblastoma: An open-label, multi-institutional phase I trial

Author

Chiocca, E Antonio, primary, Gelb, Arnold B, additional, Chen, Clark C, additional, Rao, Ganesh, additional, Reardon, David A, additional, Wen, Patrick Y, additional, Bi, Wenya Linda, additional, Peruzzi, Pierpaolo, additional, Amidei, Christina, additional, Triggs, Dan, additional, Seften, Leah, additional, Park, Grace, additional, Grant, James, additional, Truman, Kyla, additional, Buck, Jill Y, additional, Hadar, Nira, additional, Demars, Nathan, additional, Miao, John, additional, Estupinan, Taylor, additional, Loewy, John, additional, Chadha, Kamal, additional, Tringali, Joseph, additional, Cooper, Laurence, additional, and Lukas, Rimas V, additional

Published
2021
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6. CTIM-20. FINAL RESULTS OF CONTROLLED IL-12 MONOTHERAPY AND IN COMBINATION WITH PD-1 INHIBITOR IN ADULT SUBJECTS WITH RECURRENT GLIOBLASTOMA

Author

Lukas, Rimas, primary, Oberheim-Bush, Nancy Ann, additional, Cavaliere, Robert, additional, Landolfi, Joseph, additional, Yu, John S, additional, Chen, Clark, additional, Cordova, Christine, additional, Amidei, Christina, additional, Buck, Jill Y, additional, Hadar, Nira, additional, Demars, Nate, additional, Miao, John, additional, Loewy, John, additional, Estupinan, Taylor, additional, Chadha, Kamal, additional, Cooper, Laurence J N, additional, and Chiocca, E Antonio, additional

Published
2021
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8. Combined immunotherapy with controlled interleukin-12 gene therapy and immune checkpoint blockade in recurrent glioblastoma: An open-label, multi-institutional phase I trial.

Author

Chiocca, E Antonio, Gelb, Arnold B, Chen, Clark C, Rao, Ganesh, Reardon, David A, Wen, Patrick Y, Bi, Wenya Linda, Peruzzi, Pierpaolo, Amidei, Christina, Triggs, Dan, Seften, Leah, Park, Grace, Grant, James, Truman, Kyla, Buck, Jill Y, Hadar, Nira, Demars, Nathan, Miao, John, Estupinan, Taylor, and Loewy, John

Published
2022
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9. Automated search for arthritic patterns in infrared spectra of synovial fluid using adaptive wavelets and fuzzy C-means analysis

Author

Cui, Jie, Loewy, John, and Kendall, Edward J.

Subjects
Arthritis -- Diagnosis, Infrared spectroscopy -- Usage, Infrared spectroscopy -- Analysis, Form perception -- Research, Wavelet transforms -- Usage, Biological sciences, Business, Computers, Health care industry
Abstract

Analysis of synovial fluid by infrared (IR) clinical chemistry requires expert interpretation and is susceptible to subjective error. The application of automated pattern recognition (APR) may enhance the utility of IR analysis. Here, we describe an APR method based on the fuzzy C-means cluster adaptive wavelet (FCMC-AW) algorithm, which consists of two parts: one is a FCMC using the features from an M-band feature extractor adopting the adaptive wavelet algorithm and the second is a Bayesian classifier using the membership matrix generated by the FCMC. A FCMC-cross-validated quadratic probability measure (FCMC-CVQPM) criterion is used under the assumption that the class probability density is equal to the value of the membership matrix. Therefore, both values of posterior probabilities and selection criterion [M.sub.FQ] can be obtained through the membership matrix. The distinctive advantage of this method is that it provides not only the 'hard' classification of a new pattern, but also the confidence of this classification, which is reflected by the membership matrix. Index Terms--Adaptive wavelets, arthritis, infrared spectrum, pattern recognition.

Published
2006

11. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence

Author

Garbutt, James C., Kranzler, Henry R., O'Malley, Stephanie S., Gastfriend, David R., Silverman. Bernard L., Loewy, John W., Ehrich, Elliot W., and Pettinati, Helen M.

Subjects
Alcoholics -- Drug therapy, Naltrexone -- Usage
Abstract

The efficacy and tolerability of a long-acting intramuscular formulation of naltrexone for treatment of alcohol-dependent patients is determined. Results revealed that the long-acting naltrexone was well tolerated and resulted in reductions in heavy drinking among treatment-seeking alcohol-dependent patients during 6 months of therapy.

Published
2005

12. CTIM-05. COMBINATION OF CONTROLLED INTERLEUKIN-12 GENE THERAPY WITH IMMUNE CHECKPOINT BLOCKADE IN RECURRENT GLIOBLASTOMA: UPDATED RESULTS OF A MULTI-INSTITUTIONAL, OPEN LABEL PHASE 1 TRIAL

Author

Antonio Chiocca, E, primary, Lukas, Rimas, additional, Chen, Clark, additional, Rao, Ganesh, additional, Amidei, Christina, additional, Buck, Jill, additional, Hadar, Nira, additional, Demars, Nathan, additional, Miao, John, additional, Estupinan, Taylor, additional, Loewy, John, additional, Wang, Yunxia, additional, Gelb, Arnold, additional, and Cooper, Laurence, additional

Published
2020
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13. CTIM-28. PHASE 2 TRIAL OF CONTROLLED IL-12 IN COMBINATION WITH PD-1 INHIBITOR IN ADULT SUBJECTS WITH RECURRENT GLIOBLASTOMA (rGBM)

Author

Lukas, Rimas, primary, Chiocca, E Antonio, additional, Bush, Nancy Ann Oberheim, additional, Landolfi, Joseph, additional, Cavaliere, Robert, additional, Yu, John, additional, Kurz, Sylvia, additional, Demars, Nathan, additional, Buck, Jill, additional, Hadar, Nira, additional, Miao, John, additional, Loewy, John, additional, Wang, Yunxia, additional, Gelb, Arnold, additional, and Cooper, Laurence, additional

Published
2020
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14. Survival of subjects with recurrent glioblastoma receiving intratumoral administration of controlled IL-12 with limited exposure to dexamethasone.

Author

Lukas, Rimas Vincas, primary, Kurz, Sylvia Christine, additional, Yu, John, additional, Landolfi, Joseph C., additional, Rao, Ganesh, additional, Amidei, Christina, additional, Buck, Jill Yannetti, additional, Hadar, Nira, additional, Estupinan, Taylor, additional, Miao, John, additional, Loewy, John W., additional, Wang, Yunxia, additional, Demars, Nathan A., additional, Gelb, Arnold Bruce, additional, and Cooper, Laurence JN, additional

Published
2020
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15. Controlled IL-12 in combination with a PD-1 inhibitor subjects with recurrent glioblastoma.

Author

Chiocca, E. Antonio, primary, Lukas, Rimas Vincas, additional, Chen, Clark C, additional, Rao, Ganesh, additional, Amidei, Christina, additional, Buck, Jill Yannetti, additional, Hadar, Nira, additional, Demars, Nathan A., additional, Miao, John, additional, Estupinan, Taylor, additional, Loewy, John W., additional, Wang, Yunxia, additional, Gelb, Arnold Bruce, additional, and Cooper, Laurence JN, additional

Published
2020
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16. Final results of controlled IL-12 monotherapy in adults with grade III or IV gliomas.

Author

Chiocca, E. Antonio, primary, Lukas, Rimas Vincas, additional, Yu, John, additional, Yamini, Bakhtiar, additional, Oberheim Bush, Nancy Ann, additional, Amidei, Christina, additional, Buck, Jill Yannetti, additional, Demars, Nathan A., additional, Hadar, Nira, additional, Miao, John, additional, Estupinan, Taylor, additional, Wang, Yunxia, additional, Loewy, John W., additional, Gelb, Arnold Bruce, additional, and Cooper, Laurence JN, additional

Published
2020
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17. Naltrexone Treatment for Alcohol Dependency

Author

Garbutt, James C., Kranzler, Henry R., OʼMalley, Stephanie S., Gastfriend, David R., Silverman, Bernard L., Loewy, John W., Ehrich, Elliot W., and Pettinati, Helen M.

Published
2005

19. Identifying predictive variables for long-term weight change after participation in a weight loss program

Author

Lavery, Margaret A. and Loewy, John W.

Subjects
Weight loss -- Influence, Physical fitness -- Evaluation
Abstract

Objective and design To determine if there was an association between weight change and 31 independent variables among obese persons 2 years after a weight loss program. Data were obtained from subjects' records and from questionnaires administered at enrollment and after a 2-year follow-up. Setting The 8-week weight control program was taught by registered dietitians and developed by the staff at the Sid Richardson Institute for Preventive Medicine, Houston, Tex. Subjects/samples Of the 1,460 subjects who attended at least one of eight classes, 509 subjects (123 men and 386 women) responded to the mailed follow-up questionnaire. Main outcome measures Associations between weight change and the 31 independent variables were assessed. Heights and weights were measured by the dietitians during treatment. Two-year follow-up weights were self-reported. Statistical analyses performed Analysis of variance was used for 16 of the independent variables. For the remaining variable we performed a test of the null hypothesis that the correlation coefficient was 0 based on the test of the regression coefficient between the independent and dependent variable. A stepwise regression process was used to determine the best combination of variables predictive of weight change. Results Of the 31 independent variables, 16 were significantly predictive of weight change. The adjusted [R.sup.2] for the entire group of 16 variables was .379. Thus, 37.9% of the variance was explained by the joint efforts of the 16 variables. Eight variables with an adjusted [R.sup.2] of .371 (accounting for 37.1% of the variance) were most important: feeling in control of eating habits, percentage over ideal body weight at enrollment, percentage of weight lost during the 8-week treatment, frequency fo weight measurement, increase in physical activity, frequency of eating in response to emotion, number of pounds gained before subject resumed diet, and occupation. Application/conclusion The predictive variables for weight change may be useful to professionals who treat obese clients and may improve success rates of long-term weight loss. J Am Diet Assoc. 1993;93:1017-1024., Obesity is a pervasive public health problem that affects millions of Americans of all ages, sex, race, and socio-economic status. It has been identified as a risk factor for many […]

Published
1993

21. Outpatient treatment of febrile episodes in low-risk neutropenic patients with cancer

Author

Rubenstein, Edward B., Rolston, Kenneth, Benjamin, Robert S., Loewy, John, Escalante, Carmen, Manzullo, Ellen, Hughes, Pamela, Moreland, Betty, Fender, Andrew, Kennedy, Kathryn, Holmes, Frankie, Elting, Linda, and Bodey, Gerald P.

Subjects
Neutropenia -- Care and treatment, Fever -- Care and treatment, Ambulatory medical care -- Methods, Cancer patients -- Care and treatment, Antibiotics -- Health aspects, Health
Abstract

Background. Hospitalization and intravenous (IV) broad-spectrum antibiotics are the standard of care for all febrile neutropenic patients with cancer. Recent work suggests that a low-risk population exists who might benefit from an alternate approach. Methods. A prospective randomized clinical trial was performed comparing oral ciprofloxacin 750 mg plus clindamycin 600 mg every 8 hours with IV aztreonam 2 g plus clindamycin 600 mg every 8 hours for the empiric outpatient treatment of febrile episodes in low-risk neutropenic patients with cancer. Results. The oral regimen cured 35 of 40 episodes (88% response rate), whereas the IV regimen cured 41 of 43 episodes (95% response rate, P = 0.19). Although the cost of the oral regimen was significantly less than that of the IV regimen (P < 0.0001), it was associated with significant renal toxicity (P < 0.05), which led to early termination of the study. Overall, combining its safety and efficacy, the IV regimen was superior (P = 0.03). Conclusions. This prospective study suggested that outpatient antibiotic therapy for febrile episodes in low-risk neutropenic patients with cancer is safe and effective. Better oral regimens are needed.

Published
1993

25. Results of an International Randomized Phase III Trial of the Mammalian Target of Rapamycin Inhibitor Ridaforolimus Versus Placebo to Control Metastatic Sarcomas in Patients After Benefit From Prior Chemotherapy

Author

Demetri, George D., primary, Chawla, Sant P., additional, Ray-Coquard, Isabelle, additional, Le Cesne, Axel, additional, Staddon, Arthur P., additional, Milhem, Mohammed M., additional, Penel, Nicolas, additional, Riedel, Richard F., additional, Bui-Nguyen, Binh, additional, Cranmer, Lee D., additional, Reichardt, Peter, additional, Bompas, Emmanuelle, additional, Alcindor, Thierry, additional, Rushing, Daniel, additional, Song, Yang, additional, Lee, Ruey-min, additional, Ebbinghaus, Scot, additional, Eid, Joseph E., additional, Loewy, John W., additional, Haluska, Frank G., additional, Dodion, Pierre F., additional, and Blay, Jean-Yves, additional

Published
2013
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26. Phase II Study of the Mammalian Target of Rapamycin Inhibitor Ridaforolimus in Patients With Advanced Bone and Soft Tissue Sarcomas

Author

Chawla, Sant P., primary, Staddon, Arthur P., additional, Baker, Laurence H., additional, Schuetze, Scott M., additional, Tolcher, Anthony W., additional, D'Amato, Gina Z., additional, Blay, Jean-Yves, additional, Mita, Monica M., additional, Sankhala, Kamalesh K., additional, Berk, Lori, additional, Rivera, Victor M., additional, Clackson, Tim, additional, Loewy, John W., additional, Haluska, Frank G., additional, and Demetri, George D., additional

Published
2012
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27. A Phase I Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Deforolimus in Patients with Advanced Malignancies

Author

Hartford, Christine M., primary, Desai, Apurva A., additional, Janisch, Linda, additional, Karrison, Theodore, additional, Rivera, Victor M., additional, Berk, Lori, additional, Loewy, John W., additional, Kindler, Hedy, additional, Stadler, Walter M., additional, Knowles, Heather L., additional, Bedrosian, Camille, additional, and Ratain, Mark J., additional

Published
2009
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32. Preliminary evaluation of safety and activity of recombinant human interleukin 11 in patients with active Crohn's disease

Author

Sands, Bruce E., primary, Bank, Simmy, additional, Sninsky, Charles A., additional, Robinson, Malcolm, additional, Katz, Seymour, additional, Singleton, John W., additional, Miner, Philip B., additional, Safdi, Michael A., additional, Galandiuk, Susan, additional, Hanauer, Stephen B., additional, Varilek, Gary W., additional, Buchman, Alan L., additional, Rodgers, Vance D., additional, Salzberg, Bruce, additional, Cai, Bin, additional, Loewy, John, additional, DeBruin, Michael F., additional, Rogge, Holly, additional, Shapiro, Mark, additional, and Schwertschlag, Ullrich S., additional

Published
1999
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37. Automated Search for Arthritic Patterns in Infrared Spectra of Synovial Fluid Using Adaptive Wavelets and Fuzzy C-Means Analysis.

Author

Jie Cui, Loewy, John, and Kendall, Edward J.

Subjects
*ARTHRITIS, *SYNOVIAL fluid, *FUZZY mathematics, *BAYESIAN analysis, *DISTRIBUTION (Probability theory), *ALGORITHMS, *CLINICAL chemistry
Abstract

Analysis of synovial fluid by infrared (IR) clinical chemistry requires expert interpretation and is susceptible to subjective error. The application of automated pattern recognition (APR) may enhance the utility of IR analysis. Here, we describe an APR method based on the fuzzy C-means cluster adaptive wavelet (FCMC-AW) algorithm, which consists of two parts: one is a FCMC using the features from an M-band feature extractor adopting the adaptive wavelet algorithm and the second is a Bayesian classifier using the membership matrix generated by the FCMC. A FCMC-cross-validated quadratic probability measure (FCMC-CVQPM) criterion is used under the assumption that the class probability density is equal to the value of the membership matrix. Therefore, both values of posterior probabilities and selection criterion MFQ can be obtained through the membership matrix. The distinctive advantage of this method is that it provides not only the 'hard' classification of a new pattern, but also the confidence of this classification, which is reflected by the membership matrix. [ABSTRACT FROM AUTHOR]

Published
2006
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39. Sonoanatomy of the median, ulnar and radial nerves.

Author

Loewy, John

Subjects
*ULTRASONIC imaging, PERIPHERAL neuropathy diagnosis
Abstract

Examines the ultrasonography (US) anatomy of the median, ulnar and radial nerves. Symptoms of peripheral nerve lesion; Link between US radial nerve and immature ovary; Clinical features of the disease.

Published
2002

41. A Randomized Placebo-Controlled Trial of Recombinant Human Interleukin-11 in Cancer Patients With Severe Thrombocytopenia Due To Chemotherapy

Author

Tepler, Isidore, Elias, Laurence, Smith, John W., Hussein, Mohamad, Rosen, Gerald, Chang, Alex Y.-C., Moore, Joseph O., Gordon, Michael S., Kuca, Bernice, Beach, Kathleen J., Loewy, John W., Garnick, Marc B., and Kaye, James A.

Abstract

Thrombocytopenia is a complication of cancer treatment that can limit dose intensity. Interleukin-11 (IL-11) is a growth factor that increases platelet production. We conducted a multicenter, randomized, placebo-controlled trial of recombinant human IL-11 (rhlL-11) in 93 patients with cancer who had already been transfused platelets for severe thrombocytopenia resulting from chemotherapy. The patients had received platelet transfusions for nadir platelet counts of ≤20,000/μL during the chemotherapy cycle immediately preceding study entry. Chemotherapy was continued during the study without dose reduction. Patients were randomized to receive placebo or rhlL-11 at 50 or 25 Md/kg subcutaneously once daily for 14 to 21 days beginning 1 day after chemotherapy. Eight of 27 (30%) evaluable patients treated with rhlL-11 at a dose of 50 μg/kg did not require platelet transfusions versus 1 of 27 (4%) patients who received placebo [P <.05). Five of 28 (18%) patients treated with rhlL-11 at 25 μg/kg avoided platelet transfusions (P= .23). Side effects were fatigue and cardiovascular symptoms, including a low incidence of atrial arrhythmias and syncope. There were no differences among treatment groups in the incidence of neutropenic fever, days of hospitalization, or number of red blood cell transfusions. This study shows that rhlL-11 treatment at a dose of 50 μg/kg significantly increases the likelihood that patients who have already been transfused platelets for severe chemotherapy-induced thrombocytopenia will not require platelet transfusions during a subsequent chemotherapy cycle.

Published
1996
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42. A Phase I Trial of Recombinant Human Interleukin-11 (Neumega rhIL-11 Growth Factor) in Women With Breast Cancer Receiving Chemotherapy

Author

Gordon, Michael S., McCaskill-Stevens, Worta J., Battiato, Linda A., Loewy, John, Loesch, David, Breeden, Elyse, Hoffman, Ron, Beach, Kathleen J., Kuca, Bernice, Kaye, James, and Sledge, George W.

Abstract

We performed a phase I trial of recombinant human interleukin-11 (rhIL-11) in women with breast cancer. Cohorts of three to five women were accrued to five dosage levels of rhIL-11 (10, 25, 50, 75, and 100 μg/kg/d). rhIL-11 alone was administered by a daily subcutaneous injection for 14 days during a 28-day prechemotherapy “cycle 0.” Patients (pts) subsequently received up to four 28-day cycles of cyclophosphamide (1,500 mg/m2) and doxorubicin (60 mg/m2) chemotherapy followed by rhIL-11 at their assigned dose (days 3 through 14). Sixteen pts (13 stage IV, 3 stage IIIB) were accrued to this study. Median age was 53 years and median Eastern Cooperative Oncology Group Performance Status was 0. A grade 3 neurologic event was seen in 1 pt at 100 μg/kg. Because of the degree of grade 2 constitutional symptoms (myalgias/arthralgias and fatigue) at 75 μg/kg, dose escalation was stopped and 75 μg/kg was the maximally tolerated dose. No other grade 3 or 4 adverse events related to rhIL-11 were seen. The administration of rhIL-11 was not associated with fever. Reversible grade 2 fatigue and myalgias/arthralgias were seen in all pts at 75 μg/kg. Weight gain of 3% to 5% associated with edema was seen at doses > 10 μg/kg but a capillary leak syndrome was not seen. rhlL-11 alone was associated with a mean 76%, 93%, 108%, and 185% increase in platelet counts at doses of 10,25,50, and 75 μg/kg, respectively. No significant changes in leukocytes were seen. A mean 19% decrease in hematocrit was observed. Acute-phase proteins increased with treatment at all doses. Compared with patients at the 10 μg/kg dose, patients receiving doses ≥25 μg/kg experienced less thrombocytopenia in the first two cycles of chemotherapy. We conclude that rhIL-11 has thrombopoietic activity at all doses studied, is well tolerated at doses of 10, 25, and 50 fig/kg, and at doses 2:25 μg/kg has the potential to reduce chemotherapy-induced thrombocytopenia in this model.

Published
1996
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44. The battle of the budget: commentary

Author

Loewy, John H.

Subjects
United States. Department of Energy -- Finance, United States. Solar Energy Research Institute -- Finance, Solar energy industry -- Political activity, Energy policy -- Economic aspects, Presidents -- Energy policy, Solar energy industry -- Finance, Business, Construction and materials industries, Engineering and manufacturing industries
Published
1982

47. Externally Placed vs Intravaginally Positioned Radio Frequency Coils for Quantitative Spin-Spin Relaxometry of Ovarian Follicular Fluid.

Author

Sarty, Gordon E., Baerwald, Angie R., Loewy, John, and Pierson, Roger A.

Subjects
*DIAGNOSTIC imaging, *RADIO frequency, *OVARIES, *MAGNETIC resonance imaging
Abstract

Objective: To evaluate different imaging protocols, especially with respect to radio frequency (RF) receiver coil location, for their suitability in providing least squares derived quantitative T2 values of ovarian follicular fluid for investigations of basic ovarian physiology. Methods: The ovaries of 10 women were imaged via magnetic resonance imaging (MRI) using externally positioned and intravaginally placed RF receiver coils. Half-Fourier acquisition with single-shot turbo spin-echo (HASTE), multiple-echo T2, Dixon, turbo spin-echo, and 3-dimensional (3D) fast imaging with steady-state precession (FISP) and time-reversed FISP (PSIF) sequences were used. Quantitative T2 nuclear spin relaxation rate information from the ovarian follicles between data acquired with the external and intravaginal coils were compared. Additionally, the amount of ovarian follicle and corpora lutea structural detail visible was qualitatively assessed. Results: The T2 computations indicated that there was no difference in the follicular fluid T2 values or in the heterogeneity (spatial variance) of the T2 values between data acquired with the external RF coil and data acquired with the intravaginal RF coil. The best sequences for the visualization of ovarian internal structure were the 3D PSIF sequences and the multiple-echo T2-weighted images, confirming our earlier imaging work on excised cow ovaries. Conclusion: It is best to use an externally placed RF coil for quantitative MRI study of ovarian physiology given the lack of difference in quantitative T2 information and the difficulty associated with imaging the ovaries using an intravaginal RF probe. [ABSTRACT FROM AUTHOR]

Published
2005

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