The ROCKET clinical cancer trial has been shut down by the Food and Drug Administration due to three patients who died while participating in the clinical trial. Two of these patients died last year while the third died this past May. The cause of death for all three participants in the clinical trial is listed as cerebral edema or swelling in the brain. The ROCKET cancer trial was in Phase II of the testing stage when it was halted. The patients in the trial all had a relapse of B-cell acute lymphoblastic leukemia.
The ROCKET cancer trial was testing the ability of a person’s immune system to assist doctors in treating and curing cancer. Known as immunotherapy, these revolutionary cancer treatments are still highly experimental with the potential for unknown circumstances, such as what happened in the ROCKET clinical trial, to happen.
Cancer immunotherapy trial halted after patient deaths https://t.co/hAtluK7ZiB
— Graham Player Ph.D. (@gplayer) July 9, 2016
Juno is the company behind ROCKET, and when it was announced that the FDA had stopped the clinical trial, CEO Hans Bishop held a press conference over a conference call. Bishop immediately addressed the cerebral edema in the three patients that died. Bishop stated that it is believed that the edema was caused by fludarabine. Fludarabine was given to members of the cancer study as a way to reset their immune system and start the immunotherapy process.
Fludarabine was added to the clinical trial due to how it worked in other studies. Investigators into the deaths feel that fludarabine interacted in a fatal manner with JCAR015 cells. Bishop is currently in the process of negotiating with the FDA to restart the trial. Part of the negotiating on Bishop’s part is dealing with no longer using fludarabine in the cancer trial. FDA spokesperson Tara Goodin commented on how the FDA handles death in clinical trials.
“If at any time the FDA determines that human subjects are or would be exposed to an unreasonable and significant risk of illness or injury, the FDA may place the study on ‘clinical hold,’ which prohibits further investigation until the FDA’s safety concerns are adequately addressed and the FDA removes the clinical hold order.”
Latest immune therapy by Seattle biotech cancer vaccine fanatics halted after three deaths. https://t.co/nvwEZjVMzf
— The Refusers (@the_refusers) July 8, 2016
The process of getting a new drug or medical procedure to market begins with animal testing. Companies must prove to the FDA that their treatment has beneficial effects and has minimal chance of causing harm to humans in testing phases.
The first round of human testing is known as a Phase I clinical trial. In Phase I, healthy adults are used to determine what side effects exist and how the body metabolizes the medication. If Phase I goes off without problems, Phase II clinical trials will begin.
Phase II is where it is determined that the drug actually works against the disease that it is designed for. As opposed to Phase I, Phase II clinical trials ask for volunteers who have the disease that the drug is being tested on. If the FDA is satisfied with the study and results of Phase II, Phase III is allowed to occur.
Phase III is the last stage before a drug is approved to be sold. This phase helps determine what dosage should be given and how the drug works with people of varying genetic makeups. Once Phase III is complete, the drug company fills out many pieces of paperwork for the FDA to look over. If all of the data shows positive results, the FDA approves the new drug.
Do you think the ROCKET cancer clinical trial will be restarted in the future?
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