A Phase I Trial L-NNA in Patients with Advanced Solid Tumours.

• Research type

  Research Study

• Full title

  A Phase I trial of N(G)-Nitro-L-arginine (L-NNA), a nitric oxide synthase inhibitor, given as a single intravenous infusion over 10 minutes in patients with advanced solid tumours.

• IRAS ID

  30502

• Sponsor organisation

  Cancer Research UK

• Eudract number

  2009-013621-42

• ISRCTN Number

  N/A

• Research summary

  This is a phase I clinical trial of L-NNA given once as a 10 minute infusion to patients with advanced solid cancer. Nitric oxide is a small signalling molecule that's considered a potential target for anti-cancer treatment likely to be administered with radiotherapy or chemotherapy. Nitric oxide has been shown to be involved in tumour blood flow and therefore may contribute to tumour growth and progression. L-NNA is an inhibitor ot nitric oxide synthase, inhibiting the production of nitric oxide has been shown to reduce blood volume through the tumour. In a previous trial with L-NNA in cancer patients (18 patients received L-NNA at various doses), the effects of L-NNA on tumour blood volume were still be detectable after 24 hours. In this trial L-NNA will be given once to patients with advanced solid cancer. The effects of L-NNA on the tumour and normal tissue (kidney) blood flow/volume will be evaluated. The safe dose at which there is the greatest effect on tumour blood flow compared to normal tissue will be further evaluated in later trials (likely to be with either chemotherapy, radiotherapy or a repeat dosing schedule). The trial will be conducted at one site over a period of 18 to 27 months. Patients will receive L-NNA on Day 1, undergo a number of safety assessments (blood test, ECGs, cardiac monitoring) and will be required to have up to 6 CT scans. The last study related visit will be on Day 28 (or last follow up, post Day 28, of drug related adverse events). Cancer Research UK will be funding this Phase I trial.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  11/H0402/5

• Date of REC Opinion

  16 Feb 2011

• REC opinion

  Further Information Favourable Opinion