Conditions: Malignant Solid Tumor Lymphomas
Keywords: Advanced Solid Tumors Lymphomas Safety Blood flow Nitric oxide Cancer Dynamic contrast enhanced MRI (DCE-MRI) Contrast Enhanced Ultrasound (CEUS)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 26
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001 for injection in subjects with advanced solid tumors or lymphomas for which there are no currently accepted curative therapies. This study will also conduct an exploratory evaluation of objective tumor response using CT or MRI.

Detailed description:
The DINAMIC (DINitroazetidines As Medications In Cancer) trial represents a provascular approach to temporarily change tumor blood flow and oxygenation. Blood supply to most tumors is poor, causing parts of tumors to have a low oxygen content which promotes aggressiveness and metastasis. The DINAMIC trial uses specific imaging techniques (including ultrasound), biopsy, and breath analysis to provide an early assessment of therapeutic activity.

Arms:
arm 1: None

Interventions: intervention 1: RRx-001 intervention 2: RRx-001 intervention 3: RRx-001 intervention 4: RRx-001 intervention 5: RRx-001 intervention 6: RRx-001
Intervention descriptions: intervention 1: Dose level 1 (10 mg/m2) intervention 2: Dose Level 2 (16.7 mg/m2) intervention 3: Dose Level 3 (24.6 mg/m2) intervention 4: Dose Level 4 (33 mg/m2) intervention 5: Dose Level 5 (55.0 mg/m2) intervention 6: Dose Level 6 (83 mg/m2)

Protocol document: