Search Results - "Bechhofer, Robin"

Reports to Independent Data Monitoring Committees: An Appeal for Clarity, Completeness, and Comprehensibility by Buhr, Kevin A, Downs, Matthew, Rhorer, Janelle, Bechhofer, Robin, Wittes, Janet

“…Organizations presenting reports to independent data monitoring committees (IDMCs) should present data in a way that facilitates the ability of the IDMC to…”
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Monitoring a clinical trial conducted under the food and drug administration regulations allowing a waiver of prospective informed consent: The diaspirin cross-linked hemoglobin traumatic hemorrhagic shock efficacy trial by Lewis, Roger J., Berry, Donald A., Cryer, Henry, Fost, Norman, Krome, Ronald, Washington, Geraldine R., Houghton, Jaime, Blue, John W., Bechhofer, Robin, Cook, Thomas, Fisher, Marian

“…In 1996, the US Food and Drug Administration (FDA) enacted Rule 21 CFR §50.24, which allows a narrow exception to the requirement for prospective informed…”
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Regional Differences in Baseline Characteristics and Outcomes in Patients Hospitalized with Worsening Heart Failure and Systolic Dysfunction by Zannad, Faiez, Wang, Norman C, Konstam, Marvin A, Bechhofer, Robin, Gheorghiade, Mihai, Burnett, John C, Grinfeld, Liliana, Swedberg, Karl, Udelson, James E, Cook, Thomas, Ouyang, John, Zimmer, Christopher, Orlandi, Cesare, Maggioni, Aldo P

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Regional Comparison of Baseline Therapy in Patients Hospitalized for Acute Heart Failure with Systolic Dysfunction by Wang, Norman C, Konstam, Marvin A, Gheorghiade, Mihai, Bechhofer, Robin, Burnett, John C, Grinfeld, Liliana, Swedberg, Karl, Udelson, James E, Cook, Thomas, Ouyang, John, Zimmer, Christopher, Orlandi, Cesare, Maggioni, Aldo P, Zannad, Faiez

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The QRS Interval Predicts Mortality and Re-Hospitalization in Patients Hospitalized with Worsening Heart Failure and Systolic Dysfunction by Wang, Norman C, Zannad, Faiez, Konstam, Marvin A, Bechhofer, Robin, Gheorghiade, Mihai, Burnett, John C, Grinfeld, Liliana, Swedberg, Karl, Udelson, James E, Cook, Thomas, Ouyang, John, Zimmer, Christopher, Orlandi, Cesare, Maggioni, Aldo P

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Phase IB trial of chimeric antidisialoganglioside antibody plus interleukin 2 for melanoma patients by ALBERTINI, M. R, HANK, J. A, SCHILLER, J. H, KHORSAND, M, BORCHERT, A. A, GAN, J, BECHHOFER, R, STORER, B, REISFELD, R. A, SONDEL, P. M

“…We conducted a Phase IB trial of antidisialoganglioside chimeric 14. 18 (ch14.18) antibody and interleukin 2 (IL-2) to determine the maximal tolerated dose…”
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Repetitive weekly cycles of recombinant human interleukin-2: responses of renal carcinoma with acceptable toxicity by Sosman, J A, Kohler, P C, Hank, J, Moore, K H, Bechhofer, R, Storer, B, Sondel, P M

“…A phase I trial of repetitive weekly cycles of human recombinant interleukin-2 (IL-2) was performed in 23 patients with metastatic carcinoma. Patients received…”
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Clinical and immunological effects of recombinant interleukin 2 given by repetitive weekly cycles to patients with cancer by SONDEL, P. M, KOHLER, P. C, HANK, J. A, MOORE, K. H, ROSENTHAL, N. S, SOSMAN, J. A, BECHHOFER, R, STORER, B

“…Eleven patients received four consecutive weekly cycles of human recombinant interleukin 2 (IL-2) by continuous infusion for 4 days/week. Two dose levels were…”
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Repetitive weekly cycles of interleukin-2. II. Clinical and immunologic effects of dose, schedule, and addition of indomethacin by Sosman, J A, Kohler, P C, Hank, J A, Moore, K H, Bechhofer, R, Storer, B, Sondel, P M

“…Clinical trials with high doses of interleukin 2 (IL-2) have shown antitumor responses, but many of the patients have experienced severe and occasionally…”
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Clinical and immunological effects of treatment with murine anti-CD3 monoclonal antibody along with interleukin 2 in patients with cancer by HANK, J. A, ALBERTINI, M, SOSMAN, J, SONDEL, P. M, WESLY, O. H, SCHILLER, J. H, BORCHERT, A, MOORE, K, BECHHOFER, R, STORER, B, GAN, J, GAMBACORTI, C

“…Anti-CD3 mAb and interleukin 2 (IL-2) were used in a Phase I study to treat 29 patients with cancer. The anti-CD3 was given as an i.v. bolus infusion over 10…”
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The influence of autologous lymphokine-activated killer cell infusions on the toxicity and antitumor effect of repetitive cycles of interleukin-2 by Albertini, M R, Sosman, J A, Hank, J A, Moore, K H, Borchert, A, Schell, K, Kohler, P C, Bechhofer, R, Storer, B, Sondel, P M

“…Twenty patients with refractory malignancies were treated with a protocol evaluating the addition of ex vivo-activated autologous lymphokine-activated killer…”
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Serum CD25 levels during interleukin-2 therapy: dose dependence and correlations with clinical toxicity and lymphocyte surface sCD25 expression by Bogner, M P, Voss, S D, Bechhofer, R, Hank, J A, Roper, M, Poplack, D, Hammond, D, Sondel, P M

“…Using an enzyme-linked immunosorbent assay (ELISA), we have measured serum levels of a soluble form of the p55 subunit of the interleukin-2 receptor complex,…”
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Phase 1 clinical trial of recombinant interleukin-2: a comparison of bolus and continuous intravenous infusion by Kohler, P C, Hank, J A, Moore, K H, Storer, B, Bechhofer, R, Hong, R, Sondel, P M

“…The toxicologic, biologic, and clinical effects of recombinant interleukin-2 (IL-2) were tested in 25 patients with cancer. Escalating doses from 10(3) to…”
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A pilot phase II trial of continuous-infusion interleukin-2 followed by lymphokine-activated killer cell therapy and bolus-infusion interleukin-2 in renal cancer by Gambacorti-Passerini, C, Hank, J A, Albertini, M R, Borchert, A A, Moore, K H, Schiller, J H, Bechhofer, R, Borden, E C, Storer, B, Sondel, P M

“…Nine patients with metastatic renal cell carcinoma were entered into a pilot protocol including a 4-week regimen utilizing human recombinant interleukin-2…”
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In vivo induction of the lymphokine-activated killer phenomenon: interleukin 2-dependent human non-major histocompatibility complex-restricted cytotoxicity generated in vivo during administration of human recombinant interleukin 2 by HANK, J. A, KOHLER, P. C, WEIL-HILLMAN, G, ROSENTHAL, N, MOORE, K. H, STORER, B, MINKOFF, D, BRADSHAW, J, BECHHOFER, R, SONDEL, P. M

“…The availability of purified human recombinant interleukin 2 (IL-2) has enabled clinical trials to test its in vivo effects. We report here the immunological…”
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Depressed in vitro T cell responses concomitant with augmented interleukin-2 responses by lymphocytes from cancer patients following in vivo treatment with interleukin-2 by Hank, J A, Sosman, J A, Kohler, P C, Bechhofer, R, Storer, B, Sondel, P M

“…Peripheral blood lymphocytes obtained from cancer patients receiving interleukin-2 (IL-2) on two separate clinical protocols were evaluated for their in vitro…”
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The in vitro function of lymphocytes from 25 cancer patients receiving four to seven consecutive days of recombinant IL-2 by Rosenthal, N S, Hank, J A, Kohler, P C, Minkoff, D Z, Moore, K H, Bechhofer, R, Hong, R, Storer, B, Sondel, P M

“…Twenty-five cancer patients received human recombinant interleukin-2 (IL-2) for 4 to 7 consecutive days in a Phase I trial. IL-2 was administered either as a…”
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