scholarly journals Calcium Electroporation for Keloids: A First-in-Man Phase I Study

Dermatology ◽  
2021 ◽  
pp. 1-9
Author(s):  
Hanne Falk ◽  
Mille Vissing ◽  
Gitte Wooler ◽  
Julie Gehl
Keyword(s):  
Side Effects ◽  
Phase I ◽  
Phase I Study ◽  
Symptom Relief ◽  
Scar Tissue ◽  
Self Assessment ◽  
Keloid Scarring ◽  
Experienced Symptom ◽  
Volume Size

<b><i>Background:</i></b> Keloid scarring is a pathologic proliferation of scar tissue that often causes pruritus, pain, and disfigurement. Keloids can be difficult to treat and have a high risk of recurrence. Recent studies have shown promising results in the treatment of cutaneous metastases with intralesional calcium combined with electroporation (calcium electroporation). As calcium electroporation has shown limited side effects it has advantages when treating benign keloid lesions, and on this indication we performed a phase I study. <b><i>Methods:</i></b> Patients with keloids were treated with at least 1 session of calcium electroporation and followed up for 2 years. Calcium was administered intralesionally (220 mM) followed by the application of eight 100-µs pulses (400 V) using linear-array electrodes and Cliniporator (IGEA, Italy). Treatment efficacy was evaluated clinically (size, shape, erythema), by patient self-assessment (pruritus, pain, other) and assessed histologically. <b><i>Results:</i></b> Six patients were included in this small proof of concept study. Treatment was well tolerated, with all patients requesting further treatment. Two out of 6 patients experienced a decrease in keloid thickness over 30%. A mean reduction of 11% was observed in volume size, and a mean flattening of 22% was observed (not statistically significant). Five out of 6 patients reported decreased pain and pruritus. No serious adverse effects or recurrences were observed over a mean follow-up period of 338 days. <b><i>Conclusion:</i></b> In this first phase I clinical study on calcium electroporation for keloids, treatment was found to be safe with minor side effects. Overall, patients experienced symptom relief, and in some patients keloid thickness was reduced.

Long-term follow-up of a phase I study of high-dose decitabine, busulfan, and cyclophosphamide plus allogeneic transplantation for the treatment of patients with leukemias

Cancer ◽  
2003 ◽  
Vol 97 (5) ◽  
pp. 1242-1247 ◽  
Author(s):  
Marcos de Lima ◽  
Farhad Ravandi ◽  
Munir Shahjahan ◽  
Borje Andersson ◽  
Daniel Couriel ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Allogeneic Transplantation ◽  
High Dose ◽  
Long Term Follow Up

scholarly journals Significant Increase in Cytotoxic T Lymphocytes and Natural Killer Cells by Triphala: A Clinical Phase I Study

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Pratya Phetkate ◽  
Tanawan Kummalue ◽  
Yaowalak U-pratya ◽  
Somboon Kietinun
Keyword(s):  
T Cells ◽  
Side Effects ◽  
Natural Killer Cells ◽  
Phase I ◽  
Natural Killer ◽  
Phase I Study ◽  
Cytotoxic T Cells ◽  
Killer Cells ◽  
Clinical Phase ◽  
Hiv Aids

Background. Searching for drugs or herbal formulations to improve the immunity of HIV/AIDS positive people is an important issue for researchers in this field. Triphala, a Thai herbal formulation, is reported to have immunomodulatory effects in mice. However, it has not yet been investigated for immunostimulatory and side effects in healthy human volunteers.Objective. To evaluate the immunostimulatory and side effects of Triphala in a clinical phase I study.Materials and Methods. All volunteers took Triphala, 3 capsules per day for 2 weeks. Complete physical examination, routine laboratory analysis, and immunological studies were performed before ingestion and after initial meeting for 4 consecutive weeks.Results. We found that Triphala demonstrated significant immunostimulatory effects on cytotoxic T cells (CD3−CD8+) and natural killer cells (CD16+CD56+). Both of them increased significantly when compared with those of the control samples. However, no significant change in cytokine secretion was detected. All volunteers were healthy and showed no adverse effects throughout the duration of the study.Conclusion. Triphala has significant immunostimulatory effects on cellular immune response, especially cytotoxic T cells and natural killer cells. Increases in the absolute number of these cells may provide a novel adjuvant therapy for HIV/AIDS positive people in terms of immunological improvement.

Extended follow-up of outcome measures in multiple myeloma patients treated on a phase I study with bortezomib and pegylated liposomal doxorubicin

2006 ◽  
Vol 86 (3) ◽  
pp. 211-216 ◽  
Author(s):  
Suzanne E. Biehn ◽  
Dominic T. Moore ◽  
Peter M. Voorhees ◽  
Reynaldo A. Garcia ◽  
Mary Jo Lehman ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Phase I ◽  
Outcome Measures ◽  
Phase I Study ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin

scholarly journals P2.07-011 Long Follow up from Phase I Study of Nivolumab and Chemotherapy in Patients with Advanced Non-Small-Cell Lung Cancer

2017 ◽  
Vol 12 (11) ◽  
pp. S2419
Author(s):  
S. Kanda ◽  
Y. Ohe ◽  
Y. Matsumoto ◽  
S. Murakami ◽  
Y. Goto ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Phase I ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Phase I Study ◽  
Small Cell ◽  
Small Cell Lung

scholarly journals Abstract CT166: TRX-E-002-1 in treatment-refractory ovarian cancer - 3-month follow-up results from a phase I study dose escalation phase

2020 ◽  
Author(s):  
Jermaine Coward ◽  
Ganessan Kichenadasse ◽  
Paul Harnett ◽  
Kathleen Moore ◽  
Minal Barve ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase I ◽  
Dose Escalation ◽  
Phase I Study ◽  
Treatment Refractory ◽  
Study Dose

A Phase I Study of Recombinant Interleukin 2 in Melanoma Patients. Toxicity and Clinical Effects

1987 ◽  
Vol 73 (6) ◽  
pp. 575-584 ◽  
Author(s):  
Raffaele Marolda ◽  
Filiberto Belli ◽  
Augusto Prada ◽  
Fabrizio Villani ◽  
Carlo Gambacorti-Passerini ◽  
...  
Keyword(s):  
Side Effects ◽  
Phase I ◽  
Phase I Study ◽  
Interleukin 2 ◽  
Previous History ◽  
Venous Catheter ◽  
Electrolyte Imbalance ◽  
Clinical Effects ◽  
Peripheral Venous Catheter ◽  
Recombinant Interleukin 2

Toxicity and clinical effects of a new brand of recombinant interleukin 2 (rIL2, Bioleukin™, Biogen, Geneva) were evaluated by a phase I study in 12 patients with stage III melanoma. Escalating doses from 100 μg/m2 to 800 μg/m2 were administered thrice a day with bolus injections given via a peripheral venous catheter for up to a maximum of 7 days. All patients showed malaise, fever and chills and mild gastrointestinal side effects. A modest electrolyte imbalance (hypocalcemia and hypokalemia) was detected in all 12 patients. Renal toxicity as judged by serum creatinine was not observed, and hepatic toxicity was moderate with the possible exception of one patient who had an unclear previous history of liver dysfunction. Mild, transient leukopenia was found in several patients, whereas thrombocytopenia developed in 4 patients; no anemia was observed. Cutaneous rash was seen in half of the patients treated. Fluid retention was minimal, with a weight gain associated to treatment that never exceeded 10% of pretreatment body weight. Electrocardiographic alterations developed in 2 patients in the form of ventricular and supraventricular extrasystoles. In 2 patients given the highest dose of rIL2, a significant reduction in transfer lung factor for carbon monoxide was seen, indicating alterations in pulmonary functions. Other dose-related toxicities were thrombocytopenia and malaise. All side effects disappeared 2-3 days after the end of rIL2 administration. No major responses were seen in association with the 4-8 days of treatment given in this study.

Vestibular Rehabilitation Therapy Outcomes in Patients With Persistent Postural-Perceptual Dizziness

2019 ◽  
Vol 128 (4) ◽  
pp. 323-329 ◽  
Author(s):  
Ebtessam H. Nada ◽  
Ola A. Ibraheem ◽  
Mohammad R. Hassaan
Keyword(s):  
Side Effects ◽  
Symptom Relief ◽  
Management Strategies ◽  
Vestibular Rehabilitation ◽  
Therapy Outcomes ◽  
Short Term ◽  
Self Assessment ◽  
Rehabilitation Therapy ◽  
Group I

Objectives: Persistent postural-perceptual dizziness (PPPD) represents an important category of vertigo. Medical treatment and psychotherapy provide convenient control of symptoms. However, these management strategies can have inconvenient side effects and short-term relief, respectively. Vestibular rehabilitation therapy (VRT) is a self-conducted habituation program that can be personalized to the subject’s needs to give adequate symptom relief without side effects. The present study aims to test the effect of VRT on patients with PPPD. Methods: Participants were diagnosed as having PPPD by the exclusion of organic vestibular lesions. The study involved 2 groups with PPPD: Group I, treated with the VRT, and Group II, treated with the VRT plus placebo. The Dizziness Handicap Inventory (DHI), a self-assessment scale, was used to evaluate the VRT outcomes. Results: There was a significant decrease in functional, physical, and total scores on the DHI in both groups after VRT. Adding the placebo did not have supplementary outcomes. The patients who did not benefit from the VRT had a significantly longer duration of PPPD, more complex aggravating factors, more composite VRT exercises, and a higher DHI score than the patients who benefited from VRT. Conclusions: Customized VRT adequately reduced symptoms and improved quality of life in subjects with PPPD.

Psychologic Aspects of Patients Participating in a Phase I Study with the Synthetic Retinoid 4-Hydroxyphenyl Retinamide

1988 ◽  
Vol 74 (3) ◽  
pp. 353-356 ◽  
Author(s):  
Antonio Filiberti ◽  
Marcello Tamburini ◽  
Claudio Andreoli ◽  
Fiamma Buranelli ◽  
Tiziana Campa ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Sexual Life ◽  
Experimental Setting ◽  
Synthetic Retinoid ◽  
Daily Dose ◽  
Previously Treated ◽  
Set Up ◽  
Anxiety Depression

One hundred and one patients participating in a phase I study with the synthetic retinoid 4-HPR (4-hydroxyphenyl retinamide) were evaluated. The study was set up by Veronesi et al. during 1986 at the National Cancer Institute of Milan. The patients were randomized into 4 groups. of therapy: 25 in the placebo group, 25 in the group receiving a daily dose of 100 mg of HPR, 26 in the group receiving 200 nig/day of HPR, and 25 in the group receiving 300 mg/day of HPR. All patients were previously treated at our Institute for breast cancer. None had received adjuvant therapy, chemotherapy or hormone therapy. After 4–5 months from the beginning of treatment, all patients received a series of tests to evaluate anxiety, depression and sexual life. Moreover, during one the follow-up checkups after 4–5 months, the patients filled-out a self-scoring mood questionnaire. The results did not show any particular differences between the groups, although we found that the administered drug and experimental setting do not interfere with the psychologic state of the participating patients.

An evaluation of survivorship care plan program.

2017 ◽  
Vol 35 (5_suppl) ◽  
pp. 62-62
Author(s):  
Debra Spoljaric ◽  
Brittany Depp ◽  
Allison A. King
Keyword(s):  
Side Effects ◽  
Phase I ◽  
Phase Ii ◽  
Cancer Survivor ◽  
Late Effects ◽  
Survivorship Care Plan ◽  
Survivorship Care ◽  
Care Plans ◽  
The Impact

62 Background: The Commission on Cancer mandated the development and implementation of survivorship care plans (SCP) in 2015. Minimal evidence exists to suggest SCP are meaningful to survivors and primary care physicians (PCP). We sought to evaluate the usefulness of the SCP as perceived by both survivors and PCP. Methods: Phase I was 8-month pilot using a 7-page SCP detailing medical information and follow up sections addressed to the survivor and to the PCP. To evaluate patient and PCP views on the SCP, a telephone survey was created for patients and a two-page Likert scale survey for PCP was faxed. Phase I evaluations revealed 90% of survivors did not look past page 2 of the document and 16% of PCP felt it was too long and busy to read. The SCP was edited for a 3-page version and implemented in Phase II over 11-months. Results: In Phase I, 78 SCP were delivered to survivors, 58% were surveyed. Of PCP, 24% responded. In Phase II, 895 SCP were delivered, and 274 (31%) survivors surveyed. In Phase I and II, when asked to identify themselves as a cancer survivor, 282 (88%) confirmed and 21 (7%) were unsure. After reviewing the SCP, 93.1% understood their plan of care; 79.6% understood potential late effects; 33% were aware of support or resources available; 96% would recommend to another cancer survivor to get one. In Phase II, 16% (43) of PCP responded. Overall replies were positive: 61% found resource list helpful; 66% wanted more specific information about patient potential late effects; 87% agreed knowing symptoms of late effects is helpful. 70% wanted clarity on follow up tests needed and who should order. PCP overwhelmingly agreed (88%) the SCP is helpful. 90% agreed that knowing ongoing side effects of treatment was important. Conclusions: Survivors liked having their cancer treatment in one concise document and PCP physicians feel that the SCP is meeting their basic needs. PCP are interested in more specific long term side effects to monitor in their patients and direction on what follow-up tests are needed and who is ordering them. Further research is needed to study the impact of SCP on survivors’ health.

Phase I study of irinotecan/5-fluorouracil/leucovorin (FOLFIRI) with sunitinib for advanced gastroesophageal cancers (EGC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15569-e15569
Author(s):  
Sarbajit Mukherjee ◽  
Christos Fountzilas ◽  
Patrick McKay Boland ◽  
Kristopher Attwood ◽  
Wei Tan ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Kinase Inhibitor ◽  
Objective Response ◽  
Progression Free Survival ◽  
Maximum Tolerated Dose ◽  
Primary Objective ◽  
Clinical Activity ◽  
Free Survival

e15569 Background: Sunitinib (S) is a multi-targeted tyrosine kinase inhibitor with activity against VEGFR, PDGRF, KIT, FLT-3, and RET. S is synergistic with chemotherapy in preclinical models. We hypothesized that S+FOLFIRI combination will have increased efficacy in advanced EGC. Methods: This was a phase I study for patients with advanced chemo naïve EGC. Dose escalation used a standard 3+3 design. The primary objective was to determine the tolerability and safety of S+FOLFIRI. Secondary objectives were overall survival (OS), progression-free survival (PFS) and objective response rate (ORR). Results: Twenty-three patients participated in the study (Male 78%, Female 22%). Median age was 60 (Range: 37-77) years. Median follow up time was 67.5 (95% CI: 58.9, 76) months. The most frequently reported adverse events were neutropenia (78%; G3/4: 43%), nausea (74%; G3/4:13%), diarrhea (65%; G3/4: 4%), vomiting (61%, G3/4: 9%) lymphopenia (52%; G3/4: 13%) and fatigue (52%; G3/4:17%).Two dose limiting toxicities (DLTs) were noted each at dose level (DL) 1 and 1A, one at DL 1B and 3 at DL 2 (Table 1). Maximum tolerated dose was determined at DL 1B. At the time of data reporting 21 patients had died. Two patients came off the study per investigator request. All patients were evaluated for efficacy. The median OS and PFS were 12.4 (95% CI: 8.9, 16.5) months and 6.2 (95% CI: 3.4, 13.5) months, respectively. Conclusions: S+FOLFIRI was reasonably tolerated, with a manageable safety profile and signs of clinical activity in patients with advanced EGC. This study was supported by a research grant from Pfizer, Inc. Clinical trial information: NCT00524186. [Table: see text]

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