Preclinical safety testing of DISC-hGMCSF to support phase I clinical trials in cancer patients

2001 ◽  
Vol 3 (5) ◽  
pp. 458-467 ◽  
Author(s):  
Peter T. Loudon ◽  
Diane M. Blakeley ◽  
Mike E. G. Boursnell ◽  
Debbie A. Day ◽  
Imogen A. Duncan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Clinical Trials ◽  
Safety Testing ◽  
Preclinical Safety ◽  
Support Phase

Prognostic factors for cancer patients with good performance status considered for inclusion in phase I clinical trials

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2568-2568
Author(s):  
M. Bonneterre ◽  
N. Penel ◽  
M. Vanseymortier ◽  
E. Dansin ◽  
S. Clisant ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Prognostic Factors ◽  
Serum Albumin ◽  
Phase I ◽  
Cancer Patients ◽  
Cox Model ◽  
Performance Status ◽  
Univariate Analysis ◽  
Rank Test ◽  
Phase I Clinical Trials

2568 Background: For investigators, the selection of patients to be considered for phase I clinical trials is difficult, because of the lack of objective criteria for a rational decision-making process. From October 1997 to October 2002, we retrospectively assessed prognostic factors for cancer patients considered for Phase 1 trials. Methods: 148 consecutive patients who had been screened for inclusion in 6 different phase I trials were included in the present study. 70 out of them actually received the phase I treatment. Univariate (Log-Rank test) and multivariate analysis (Cox proportional hazard ratio model) were performed to determine the prognostic factors related to overall survival (OS) after screening. Results: The study comprised 63 men and 85 women, with a median age of 54 (range 23–79). The most frequent primary cancer sites were: breast (38 cases), head and neck (28 cases), lung (18 cases) and colorectal (17 cases). 91 out of them had a performance status PS = 0. The median OS of the 148 patients was 5.7 months (173 days, range 1–2,421). Univariate analysis identified PS = 1, Body Mass Index < 20, liver and visceral metastasis, serum albumin < 38 g/L, lymphocytes count < 0.7 x 109/L and granulocytes count > 7.5 x 109/L as poor prognostic factors. The Cox model identified serum albumin < 38 g/L (HR 2.51 [1.51–4.18], p=0.0001) and lymphocyte count < 0.7 x 109/L (HR 2.27 [1.13–4.62], p=0.024) as independent prognostic variables for OS. All patients presenting with both prognostic factors died within 90 days. Conclusion: We propose a simple model, easily obtained at the patient bedside, which can discriminate patients who have a life expectancy of over 3 months and thus could be enrolled in phase-I anti-cancer trials. No significant financial relationships to disclose.

Integration of specialty palliative care in a phase I ovarian cancer population.

2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 75-75
Author(s):  
Marisa R Moroney ◽  
Breana Hill ◽  
Jeanelle Sheeder ◽  
Jennifer Robinson Diamond ◽  
Melony Avella-Howell ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Palliative Care ◽  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Disease Stage ◽  
Phase I Clinical Trials ◽  
Care Services ◽  
Palliative Care Services

75 Background: ASCO guidelines recommend patients with advanced cancer receive early integrated specialty palliative care based on evidence of multiple clinical benefits. To our knowledge, there is no literature evaluating utilization of specialty palliative care in Phase I clinical trial patients, but there is limited data demonstrating underutilization of palliative care services in patients with life-threatening diseases including advanced cancer. Methods: A retrospective review of ovarian cancer patients enrolled in Phase I clinical trials at one institution from 2008 to 2018. Charts were reviewed for patient and disease characteristics including age, disease stage, number of chemotherapy regimens and date of death. Charts were also reviewed to determine if and when patients received specialty palliative care services. Results: A total of 121 patients with ovarian cancer were enrolled in Phase I clinical trials. Median age at time of Phase I enrollment was 59 years (range 33-88). 87% of patients had advanced stage disease: 60% Stage III and 27% Stage IV. Median number of chemotherapy regimens received prior to Phase I enrollment was 5 (range 1-13). Median survival was 311 days (95%CI 225.9-396.1). Of the 121 patients, 4 (3.3%) received specialty palliative care prior to Phase I enrollment, 7 (5.8%) within 30 days after enrollment, and 53 (43.8%) more than 30 days after enrollment. 57 patients (47.1%) never received specialty palliative care. Conclusions: Ovarian cancer patients enrolled in Phase I clinical trials have advanced cancer – defined by ASCO as disease that is late-stage and life limiting with a prognosis less than 24 months – and should therefore receive early integrated specialty palliative care. This study demonstrates that a significant portion of Phase I ovarian cancer patients are either receiving no or late integration of specialty palliative care. Further work needs to focus on increasing early integration of specialty palliative care in this population.

scholarly journals Clinical outcomes of breast cancer patients treated in phase I clinical trials at University of Colorado Cancer Center

2020 ◽  
Vol 9 (23) ◽  
pp. 8801-8808
Author(s):  
Jennifer A. Weiss ◽  
Andrew Nicklawsky ◽  
Jodi A. Kagihara ◽  
Dexiang Gao ◽  
Christine Fisher ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Cancer Center ◽  
Breast Cancer Patients ◽  
Phase I Clinical Trials ◽  
University Of Colorado

Survival and clinical outcomes of ovarian cancer patients enrolled in phase I clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5559-5559
Author(s):  
Bradley Corr ◽  
Marisa Moroney ◽  
Jeanelle Sheeder ◽  
Brandon Sawyer ◽  
S. Gail Eckhardt ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ovarian Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Ca 125 ◽  
Phase I Trials ◽  
Phase I Clinical Trials ◽  
Heavily Pretreated

5559 Background: Ovarian cancer patients who enroll in Phase I clinical trials are typically platinum resistant, heavily pretreated patients with a poor prognosis. Historically, clinical benefit of Phase I trials in this patient population has been uncertain. We assessed prognostic factors and survival in women with recurrent, previously treated ovarian cancer who enrolled in Phase I clinical trials. Methods: We performed a retrospective analysis of all ovarian cancer patients who were treated on Phase I clinical trials from 2008 through 2018 at the University of Colorado Cancer Center. Patient characteristics, treatment-related toxicities and survival data were assessed. Descriptive statistics and Cox proportional hazards models were utilized to identify risk factors associated with survival time. Results: A total of 132 individual patients were treated on Phase I clinical trials. Patients had a median age of 59 years (range 33-88) with a median of 5.5 (range 1-13) previous chemotherapy lines. 53/132 (40%) of patients were treated on multiple Phase I trials with a median of 1 (range 0-5) prior Phase 1 clinical trial enrollments. All patients had an ECOG performance status of 0 or 1. Overall response rate (defined as complete or partial response) was 9% and disease control rate (defined as complete or partial response or stable disease as best response) was 33%. Median overall survival (OS) was 11.5 months (95% CI: 9.3-13.7). Two patients died on trial due to progression of disease while no patients died due to treatment-related toxicity. In multivariate analysis, independent risk factors predicting shorter survival were elevated CA-125 (HR 2.8; 95% CI: 1.6-5.2) and albumin < 3.5 g/dL (HR 2.5; 95% CI: 1.65-3.79). BMI > 25 predicted longer survival (HR 0.65; 95% CI: 0.44-0.96). Conclusions: Phase I clinical trials for heavily pretreated ovarian cancer patients are safe by a standard of no patients experiencing toxicity-related deaths in our study. They are clinically efficacious with patients experiencing OS of 11.5 months, which is comparable to existing approved therapies. Elevated CA-125 and low albumin levels predict shorter survival, while BMI > 25 predicts longer survival. Phase I clinical trial options should be considered for all heavily pretreated ovarian cancer patients if available to them.

scholarly journals Clinical Outcomes and Survival of Advanced Renal Cancer Patients in Phase I Clinical Trials

2014 ◽  
Vol 12 (5) ◽  
pp. 359-365 ◽  
Author(s):  
Laeeq Malik ◽  
Helen Parsons ◽  
Devalingam Mahalingam ◽  
Benjamin Ehler ◽  
Martin Goros ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Renal Cancer ◽  
Phase I Clinical Trials ◽  
Advanced Renal Cancer
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