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Sponsored by: |
Diffusion Pharmaceuticals LLC |
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Information provided by: | Diffusion Pharmaceuticals LLC |
ClinicalTrials.gov Identifier: | NCT00826930 |
The purpose of this study is to evaluate the impact of Trans Sodium Crocetinate (TSC) on oxygen levels in brain tumor tissue in patients with high grade glioma. The proposed clinical indication for TSC is a radiation sensitizer for the treatment of cancerous tumors.
Condition | Intervention | Phase |
---|---|---|
High Grade Glioma |
Drug: Trans Sodium Crocetinate (TSC) |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Study to Determine the Effect of Trans Sodium Crocetinate (TSC) on Intra-Tumoral Oxygen Concentration, Tolerability, and Pharmacokinetics of TSC in Post-Operative Patients With High Grade Glioma (HGG) |
Estimated Enrollment: | 48 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1A: Experimental
0.5 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none
|
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
|
2A: Experimental
0.75 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none
|
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
|
3A: Experimental
1.0 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none
|
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
|
4A: Experimental
Dose of TSC either 0.5 mg/kg, 0.75 mg/kg, or 1.0 mg/kg based on the Data Monitoring Committee decision, anticonvulsants at Baseline - phenytoin only or none
|
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
|
1B: Experimental
0.5 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none
|
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
|
2B: Experimental
0.75 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none
|
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
|
3B: Experimental
1.0 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none
|
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
|
4B: Experimental
Dose of TSC either 0.5 mg/kg, 0.75 mg/kg, or 1.0 mg/kg based on the Data Monitoring Committee decision, anticonvulsants at Baseline - any except phenytoin-only or none
|
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
|
In this open-label, one-site study, up to 48 patients with high grade glioma (HGG) who are undergoing biopsy or partial debulking of the tumor as part of standard of care will have an oxygen monitoring probe placed in residual tumor tissue. Oxygen levels in the tumor tissue will be measured prior to and after administering a single bolus injection of TSC. Safety assessments will occur throughout the trial, including at a 7 to 14 day follow-up visit. Pharmacokinetic assessments will be performed prior to and during the first 24 hours after TSC dosing.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kim M. Whitten, PharmD, RAC | (434) 220-0718 | kwhitten@diffusionpharma.com |
Contact: Jenny S. Tornqvist, PhD | (434) 220-0718 | jtornqvist@diffusionpharma.com |
United States, Maryland | |
Johns Hopkins Medical Institute/Johns Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Principal Investigator: Stuart A. Grossman, MD | |
Sub-Investigator: Arati Desai, MD, MAS |
Responsible Party: | Diffusion Pharmaceuticals LLC ( Kim M. Whitten, PharmD, RAC ) |
Study ID Numbers: | DP100-201 |
Study First Received: | January 21, 2009 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00826930 History of Changes |
Health Authority: | United States: Food and Drug Administration |
High Grade Glioma Brain Tumor Solid Tumor Partial Debulking |
Tumor Resection Tumor Tissue Hypoxia Radiation Sensitizer Cancerous Tumor |
Neuroectodermal Tumors Brain Neoplasms Radiation-Sensitizing Agents Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Glioma Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |