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Trans Sodium Crocetinate (TSC) Study of Intra-Tumoral Oxygen Concentration, Safety, and Pharmacokinetics in Patients With High Grade Glioma
This study is currently recruiting participants.
Verified by Diffusion Pharmaceuticals LLC, March 2009
First Received: January 21, 2009   Last Updated: March 31, 2009   History of Changes
Sponsored by: Diffusion Pharmaceuticals LLC
Information provided by: Diffusion Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00826930
  Purpose

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)

Resource links provided by NLM:


Further study details as provided by Diffusion Pharmaceuticals LLC:

Primary Outcome Measures:
  • Change from baseline in tumor tissue oxygen monitoring recordings [ Time Frame: Daily while inpatient ] [ Designated as safety issue: No ]
  • Safety assessments (laboratory tests) [ Time Frame: Daily while inpatient, 7-14 Day Follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic assessments [ Time Frame: Day 1, Day 2 ] [ Designated as safety issue: No ]
  • Tumor hypoxia biomarkers (HIF 1-alpha, osteopontin, carbonic anhydrase IX) [ Time Frame: Daily while inpatient ] [ Designated as safety issue: No ]

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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old.
  • Prior histological diagnosis of high grade glioma (HGG) with prior initial treatment and radiation therapy for HGG; recurrence of HGG suspected, and care plan includes surgical procedure.
  • Undergoing surgical procedure for clinical reasons, and gross surgical resection not expected.
  • Neurosurgeon is planning stereotactic biopsy or tumor debulking for clinical reasons; frozen tissue confirmation of malignancy during this operative procedure is necessary.
  • Neurosurgeon evaluates that placement of oxygen monitoring probe after biopsy or debulking can be done safely without complications.
  • Contrast enhancing disease on MRI within 21 days prior to enrollment.
  • Karnofsky Performance Score ≥ 60 at Screening.
  • Recovered from toxicity of prior antineoplastic therapy, and off cytotoxic chemotherapy for 7 days prior to Screening.
  • Recovered from prior radiotherapy and had at least 21 days elapse since completion of radiotherapy prior to Screening.
  • Recovered from prior surgery for their brain tumor in investigator's clinical judgment.
  • If female, negative serum or urine pregnancy test at Screening.
  • Within 2 weeks of starting study, hematologic and renal functions as specified: Absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9.0g/dL, creatinine ≤ 1.7mg/dl, serum bilirubin ≤ 1.5mg/dL, blood urea nitrogen within 2 times the upper limit of normal, transaminases ≤ 4 times above the upper limits of the institutional norm, and prothrombin time and partial thromboplastin time within institutional norm or below.
  • Patient or patient's medical power of attorney provided written consent to participate in the study.
  • Mini Mental Status Exam score ≥ 15.

Exclusion Criteria:

  • Pregnant or lactating.
  • Receiving concurrent cytotoxic chemotherapy for their tumor within 7 days prior to Screening, or decision is made at the time of surgery to treat with other modality of treatment (e.g., gliadel wafers).
  • Serious concurrent infection or medical illness which would jeopardize the ability of the patient to safely participate.
  • Behavioral, cognitive, or psychiatric disease or personal situation that might interfere with optimal participation.
  • Cannot undergo an MRI.
  • Received an investigational drug not approved for human use by the FDA within 30 days of enrollment.
  • Previously received TSC.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826930

Contacts
Contact: Kim M. Whitten, PharmD, RAC (434) 220-0718 kwhitten@diffusionpharma.com
Contact: Jenny S. Tornqvist, PhD (434) 220-0718 jtornqvist@diffusionpharma.com

Locations
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            
Sponsors and Collaborators
Diffusion Pharmaceuticals LLC
  More Information

No publications provided

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

Keywords provided by Diffusion Pharmaceuticals LLC:
High Grade Glioma
Brain Tumor
Solid Tumor
Partial Debulking
Tumor Resection
Tumor Tissue Hypoxia
Radiation Sensitizer
Cancerous Tumor

Study placed in the following topic categories:
Neuroectodermal Tumors
Brain Neoplasms
Radiation-Sensitizing Agents
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009