Abstract

The objectives of this Phase II trial are: Primary: To evalute the efficacy of intratumoral/interstitial regional therapy with HN-66000 in patients with refractory and progressive glioblastoma mulitforme (GBM) or anaplastic astrocytoma (AA). Efficacy will be determined by comparing measurement of tumor volume on contrast-enhanced MRI before treatment with HN-66000 with measurements of tumor volume made after two separate treatments with HN-66000. To evaluate the safety of intratumoral/interstitial regional therapy with HN-66000 by observing and questioning patients for adverse events. All patients will be followed with extensive neurological examinations, MRI examinations, and blood and urine chemistry profiles. Secondary: To evaluate and compare possible differences in efficacy between histological types (GMB or AA), degree of transferring receptor expression in tumor tissue and serum antidiphtheria antibody titer levels. To estimate survival at 6 and 12 months.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR001070-23
Application #
6286809
Study Section
General Clinical Research Centers Committee (CLR)
Project Start
1977-03-01
Project End
2000-11-30
Budget Start
Budget End
Support Year
23
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

Name
Medical University of South Carolina
Department
Type
DUNS #
183710748
City
Charleston
State
SC
Country
United States
Zip Code
29425

  Publications

Kelly, Clare B; Hookham, Michelle B; Yu, Jeremy Y et al. (2018) Subclinical First Trimester Renal Abnormalities Are Associated With Preeclampsia in Normoalbuminuric Women With Type 1 Diabetes. Diabetes Care 41:120-127
Putterman, Chaim; Pisetsky, David S; Petri, Michelle et al. (2018) The SLE-key test serological signature: new insights into the course of lupus. Rheumatology (Oxford) 57:1632-1640
Hall, Jordan T; Ebeling, Myla; Shary, Judy R et al. (2018) The relationship between physical activity and vitamin D status in postpartum lactating and formula-feeding women. J Steroid Biochem Mol Biol 177:261-265
Kelly, Clare B; Hookham, Michelle B; Yu, Jeremy Y et al. (2018) Response to Comment on Kelly et al. Subclinical First Trimester Renal Abnormalities Are Associated With Preeclampsia in Normoalbuminuric Women With Type 1 Diabetes. Diabetes Care 2018;41:120-127. Diabetes Care 41:e102-e103
Bell, Katherine A; Wagner, Carol L; Perng, Wei et al. (2018) Validity of Body Mass Index as a Measure of Adiposity in Infancy. J Pediatr 196:168-174.e1
Sen, Sarbattama; Penfield-Cyr, Annie; Hollis, Bruce W et al. (2017) Maternal Obesity, 25-Hydroxy Vitamin D Concentration, and Bone Density in Breastfeeding Dyads. J Pediatr 187:147-152.e1
Wolf, Bethany J; Spainhour, John C; Arthur, John M et al. (2016) Development of Biomarker Models to Predict Outcomes in Lupus Nephritis. Arthritis Rheumatol 68:1955-63
Wagner, C L; Baggerly, C; McDonnell, S et al. (2016) Post-hoc analysis of vitamin D status and reduced risk of preterm birth in two vitamin D pregnancy cohorts compared with South Carolina March of Dimes 2009-2011 rates. J Steroid Biochem Mol Biol 155:245-51
Hollis, Bruce W; Wagner, Carol L (2016) Response to commentary by D Roth. Evid Based Med 21:120
Hollis, Bruce W; Wagner, Carol L; Howard, Cynthia R et al. (2015) Maternal Versus Infant Vitamin D Supplementation During Lactation: A Randomized Controlled Trial. Pediatrics 136:625-34

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