scholarly journals Spinal intraarterial chemotherapy: interim results of a Phase I clinical trial

2016 ◽  
Vol 24 (2) ◽  
pp. 217-222 ◽  
Author(s):  
Athos Patsalides ◽  
Yoshiya Yamada ◽  
Mark Bilsky ◽  
Eric Lis ◽  
Ilya Laufer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiation Therapy ◽  
Phase I ◽  
Metastatic Disease ◽  
Spinal Metastases ◽  
Cord Compression ◽  
Local Tumor Control ◽  
Phase I Clinical Trial ◽  
Intraarterial Chemotherapy ◽  
Tumor Control

OBJECT Despite advances in therapies using radiation oncology and spinal oncological surgery, there is a subgroup of patients with spinal metastases who suffer from progressive or recurrent epidural disease and remain at risk for neurological compromise. In this paper the authors describe their initial experience with a novel therapeutic approach that consists of intraarterial (IA) infusion of chemotherapy to treat progressive spinal metastatic disease. METHODS The main inclusion criterion was the presence of progressive, metastatic epidural disease to the spine causing spinal canal compromise in patients who were not candidates for the standard treatments of radiation therapy and/or surgery. All tumor histological types were eligible for this trial. Using the transfemoral arterial approach and standard neurointerventional techniques, all patients were treated with IA infusion of melphalan in the arteries supplying the epidural tumor. The protocol allowed for up to 3 procedures repeated at 3- to 6-week intervals. Outcome measures included physiological measures: 1) periprocedural complications according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events; and 2) MRI to assess for tumor response. RESULTS Nine patients with progressive spinal metastatic disease and cord compression were enrolled in a Phase I clinical trial of selective IA chemotherapy. All patients had metastatic disease from solid organs and were not candidates for further radiation therapy or surgery. A total of 19 spinal intraarterial chemotherapy (SIAC) procedures were performed, and the follow-up period ranged from 1 to 7 months (median 3 months). There was 1 serious adverse event (febrile neutropenia). Local tumor control was seen in 8 of 9 patients, whereas tumor progression at the treated level was seen in 1 patient. CONCLUSIONS These preliminary results support the hypothesis that SIAC is feasible and safe.

scholarly journals DDRE-17. A PHASE I CLINICAL TRIAL OF DOSE-ESCALATED METABOLIC THERAPY COMBINED WITH CONCOMITANT RADIATION THERAPY IN HIGH-GRADE GLIOMA

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. i10-i10
Author(s):  
Keren Porper ◽  
Yael Shpatz ◽  
Luba Plotkin ◽  
Ronit Goldman Pechthold ◽  
Alisa Talianski ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiation Therapy ◽  
Phase I ◽  
Dietary Intervention ◽  
Recurrent Disease ◽  
Phase I Clinical Trial ◽  
High Grade ◽  
Newly Diagnosed ◽  
Mtor Inhibition ◽  
Metabolic Therapy

Abstract BACKGROUND Animal brain-tumor models have demonstrated a synergistic interaction between radiation therapy and a ketogenic diet (KD). Metformin has in-vitro anti-cancer activity, through AMPK activation and mTOR inhibition. We sought to assess the feasibility of combined radiation, KD and metformin in adults with high grade gliomas. METHODS A prospective single-institution phase I clinical trial of combined metabolic therapy and radiotherapy. Radiotherapy was either 60Gy over six weeks or 35Gy over two weeks for newly diagnosed and recurrent gliomas, respectively. The dietary intervention consisted of a KD supplemented with medium chain triglycerides (MCT). There were three cohorts 1) dietary intervention alone, 2) low-dose metformin combined with dietary intervention and 3) high-dose metformin combined with dietary intervention. Clinicaltrials.gov NCT02149459. RESULTS A total of 13 patients were accrued, median age 61 years, of whom 6 had newly diagnosed and 7 with recurrent disease. All completed radiation therapy; 5 patients stopped the metabolic intervention early. Metformin 850mg three-times daily was poorly tolerated. There were no grade 4 / 5 adverse events, and only one grade 3 event (nausea). The median level of ketones during the intervention was 0.5 mM. Ketone levels were associated with dietary factors (high fat, low carbohydrates, MCT intake), use of metformin and low insulin levels. Median progression free survival was 10 months for newly diagnosed disease and 4 months for recurrent disease. CONCLUSIONS The intervention was fairly well tolerated, however only moderate ketones levels were obtained. Metformin use and dietary intake were associated with higher serum ketone levels. The recommended phase II dose is the 8 weeks of a low-carbohydrate diet combined with 850mg metformin twice daily.

Patient outcomes and tumor control in single-fraction versus hypofractionated stereotactic body radiation therapy for spinal metastases

2020 ◽  
pp. 1-10
Author(s):  
Christine Park ◽  
Elizabeth P. Howell ◽  
Vikram A. Mehta ◽  
Luis Ramirez ◽  
Meghan J. Price ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Total Dose ◽  
Stereotactic Body Radiation Therapy ◽  
Spinal Metastases ◽  
Local Tumor Control ◽  
Tumor Control ◽  
Local Tumor ◽  
Single Fraction ◽  
Median Total Dose

OBJECTIVEStereotactic body radiation therapy (SBRT) offers efficient, noninvasive treatment of spinal neoplasms. Single-fraction (SF) high-dose SBRT has a relatively narrow therapeutic window, while hypofractionated delivery of SBRT may have an improved safety profile with similar efficacy. Because the optimal approach of delivery is unknown, the authors examined whether hypofractionated SBRT improves pain and/or functional outcomes and results in better tumor control compared with SF-SBRT.METHODSThis is a single-institution retrospective study of adult patients with spinal metastases treated with SF- or three-fraction (3F) SBRT from 2008 to 2019. Demographics and baseline characteristics, radiographic data, and posttreatment outcomes at a minimum follow-up of 3 months are reported.RESULTSOf the 156 patients included in the study, 70 (44.9%) underwent SF-SBRT (median total dose 1700 cGy) and 86 (55.1%) underwent 3F-SBRT (median total dose 2100 cGy). At baseline, a higher proportion of patients in the 3F-SBRT group had a worse baseline profile, including severity of pain (p < 0.05), average use of pain medication (p < 0.001), and functional scores (p < 0.05) compared with the SF-SBRT cohort. At the 3-month follow-up, the 3F-SBRT cohort experienced a greater frequency of improvement in pain compared with the SF-SBRT group (p < 0.05). Furthermore, patients treated with 3F-SBRT demonstrated a higher frequency of improved Karnofsky Performance Scale (KPS) scores (p < 0.05) compared with those treated with SF-SBRT, with no significant difference in the frequency of improvement in modified Rankin Scale scores. Local tumor control did not differ significantly between the two cohorts.CONCLUSIONSPatients who received spinal 3F-SBRT more frequently achieved significant pain relief and an increased frequency of improvement in KPS compared with those treated with SF-SBRT. Local tumor control was similar in the two groups. Future work is needed to establish the relationship between fractionation schedule and clinical outcomes.

scholarly journals Safety of pioglitazone during and after radiation therapy in patients with brain tumors: a phase I clinical trial

2018 ◽  
Vol 145 (2) ◽  
pp. 337-344 ◽  
Author(s):  
Christina K. Cramer ◽  
Natalie Alphonse-Sullivan ◽  
Scott Isom ◽  
Linda J. Metheny-Barlow ◽  
Tiffany L. Cummings ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiation Therapy ◽  
Brain Tumors ◽  
Phase I ◽  
Phase I Clinical Trial
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