Melanoma Clinical Trials Worth a Shot

Melanoma patients in clinical trials may see benefits but toxic reactions are still a risk

(RxWiki News) Treating melanoma is notoriously tricky. Doctors may hesitate to recommend clinical trials fearing the risks for patients outweigh the rewards. But these fears may be unfounded.

A recent study weighed the benefits and risks involved in clinical trial medications for melanoma patients.

The researchers found that patients had similar rates of toxic reactions and clinical benefits with clinical trial medications and standard melanoma medications.

"Talk to an oncologist about clinical trial options."

Jason Luke, MD, from the Melanoma Disease Center at the Dana-Farber Cancer Institute in Boston, MA, and fellow scientists wanted to know if phase I clinical trials for patients with melanoma were more dangerous than standard treatments.

Malignant melanoma is the deadliest form of skin cancer. It can spread quickly and infect vital organs and lymph nodes. Once melanoma has spread through the body, treatment options are limited and the odds of winning the cancer battle decrease.

Clinical trials offer patients a chance to participate in the testing of new medications. Medications go through multiple clinical trial phases before the trial results are presented to the US Food and Drug Administration for approval.

Since clinical trials are used to test new medications, there is a risk the medications could be dangerous or ineffective. However, patients may also benefit from the new medications. 

For this study, researchers looked at all phase I melanoma clinical trials sponsored by the National Cancer Institute-Cancer Therapy Evaluation Program (NCI-CTEP) between 1995 and 2011. Altogether, 937 patients with melanoma were treated in 148 CTEP phase I trials.

The researchers compared the CTEP results to six phase III clinical trials for the chemotherapy medication dacarbazine, brand name DTIC. Dacarbazine is currently one of the standard treatments for melanoma.

Dacarbazine was ineffective in nearly half of patients in the phase I trials being studied.

Researchers found:

  • An average of 6 percent of study members had tumor reduction with the trial medications and 27 percent of patients’ tumors stopped spreading
  • In the phase III trials involving dacarbazine prior to its approval, 9 percent of patients had tumor reduction and 28 percent of patients’ tumors stopped spreading
  • 28 percent of patients had life-threatening toxic reactions to the trial medicines, and 54 percent had serious, but not life-threatening, reactions

“With these data in mind, melanoma patients with good performance status, and the physicians treating them, should consider the pros and cons of treatment on a phase I protocol in the same general setting that they would entertain treatment with standard of care dacarbazine chemotherapy,” the authors wrote.

This study was published in February in Melanoma Research.

No outside funding was used for this project. No conflicts of interest were declared.

Review Date: 
February 21, 2013