“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial looking at SJG-136 for advanced cancer (PH1/095)
This trial was looking at a treatment called SJG-136 for advanced solid tumours (not lymphoma or leukaemia). This trial was supported by Cancer Research UK.
SJG-136 is a type of anti cancer drug called a DNA binding agent. It binds to the genetic material (DNA) inside the cancer cell. This damages the cell, and means it cannot divide to produce new cancer cells.
This was the first time that SJG-136 was given to patients. The aims of this phase 1 trial were to find out
- The best dose of SJG-136 to give
- What the side effects are
- What happens to SJG-136 inside the body
- How well it works as an anti cancer treatment
Summary of results
The results of this trial showed that although SJG-136 did change the DNA inside cancer cells, it also caused some serious side effects.
This trial recruited 16 people with advanced cancer. They all had SJG-136 through a drip into a vein once every 3 weeks. Each 3 week period is called a cycles of treatment. They had an average of 3 cycles.
The trial was designed as a dose escalation trial. This means that the first few people taking part have the lowest dose. The next few people taking part have a higher dose. And so on, until the trial team find the best dose to give. But SJG-136 caused some serious and unexpected side effects as the dose was increased. So the research team lowered the dose again.
The most common side effect was something called vascular leak syndrome (VLS). This means that fluid leaks out of the blood vessels into other parts of the body. The fluid can collect in the abdomen (ascites), around the lungs (pleural effusion) or in arms and legs (peripheral oedema).
SJG-136 also affected the liver and some people taking part had abnormal liver function test results.
The research team looked at what effect SJG-136 had on cancer 6 weeks after starting treatment. They were able to assess 12 of the people taking part. The cancer had stayed the same in 10 people. Doctors call this stable disease. Two of those people still had stable disease 3 months after treatment. But it continued to grow in the other 2 people.
The trial team concluded that more laboratory work should be done to find out why SJG-136 caused leakage from blood vessels and liver problems.
We have based this summary on information from the team who ran the trial. As far as we are aware, the information they sent us has not been reviewed independently (
How to join a clinical trial
Dr Daniel Hochhauser
Cancer Research UK (Centre for Drug Development)
National Cancer Institute (NCI)
This is Cancer Research UK trial number CRUKD/04/037.