Trans Sodium Crocetinate (TSC) Study of Intra-tumoral Oxygen Concentration, Safety, and Pharmacokinetics in Patients With High Grade Glioma

NCT00826930 | Terminated Phase 1 DMC

• 1 other identifier: DP100-201
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

High Grade Glioma

Keywords

High Grade Glioma; Brain Tumor; Solid Tumor; Partial Debulking; Tumor Resection; Tumor Tissue Hypoxia; Radiation Sensitizer; Cancerous Tumor

Outcome Measures

Primary Outcomes (2)

• Change from baseline in tumor tissue oxygen monitoring recordings

  Daily while inpatient

• Safety assessments (laboratory tests)

  Daily while inpatient, 7-14 Day Follow-up

Secondary Outcomes (2)

• Pharmacokinetic assessments

  Day 1, Day 2

• Tumor hypoxia biomarkers (HIF 1-alpha, osteopontin, carbonic anhydrase IX)

  Daily while inpatient

Study Arms (8)

1A

EXPERIMENTAL

0.5 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none

Drug: Trans Sodium Crocetinate (TSC)

2A

EXPERIMENTAL

0.75 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none

Drug: Trans Sodium Crocetinate (TSC)

3A

EXPERIMENTAL

1.0 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none

Drug: Trans Sodium Crocetinate (TSC)

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)

1B

EXPERIMENTAL

0.5 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none

Drug: Trans Sodium Crocetinate (TSC)

2B

EXPERIMENTAL

0.75 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none

Drug: Trans Sodium Crocetinate (TSC)

3B

EXPERIMENTAL

1.0 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none

Drug: Trans Sodium Crocetinate (TSC)

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)

Interventions

Trans Sodium Crocetinate (TSC) DRUG

Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.

1A; 1B; 2A; 2B; 3A; 3B; 4A; 4B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diffusion Pharmaceuticals Inc: lead

Study Sites (1)

Johns Hopkins Medical Institute/Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Interventions

trans-sodium crocetinate

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 12, 2010

Record last verified: 2010-08

Locations

US (1)