Experimental melanoma shots to end in September
Monday, July 15th 2002, 12:00 am
By: News On 6
TULSA, Okla. (AP) _ Melanoma patients who have received an experimental drug under a special federal ruling have learned that their vaccine shots will end in September.
Notice has been given by University of Oklahoma officials in Tulsa to about half a dozen melanoma survivors, the remaining patients in a controversial cancer study conducted at OU's medical school in Tulsa.
The study and its experimental vaccine was discontinued in March 2000 due to safety concerns for the patients involved.
Under a special exception by the Food and Drug Administration in August 2000, the study was extended for two years for 12 late-stage melanoma sufferers wanting to continue it.
During the past two years, the skin cancer survivors received shots of the vaccine, which was developed by former OU researcher J. Michael McGee.
Since that time, three of the patients have died from a progression of their cancer while three others dropped out of the program, said Gary Raskob, associate vice president for clinical research and dean of OU's College of Public Health in Oklahoma City.
The remaining cancer survivors still receiving the shots see the experimental vaccine as their only chance for combatting the cancer.
``It feels like a death sentence to me if the shots are not continued,'' said one of the study participants, Rosemarie Whisman of Claremore.
Whisman, 61, who was first diagnosed with melanoma in 1994, said the cancer ``is known to come back again and again.''
``After the last shot, I'll wonder every time I get a pain or headache if it's back,'' she said.
After surgery in 1994 to remove a stage four tumor _ one of the deadliest stages of the cancer _ Whisman said she was cancer free until 1999 when doctors again removed a malignant lump from her body.
Whisman said she has been tumor and cancer free since enrolling in the melanoma study conducted at OU's College of Medicine in Tulsa and at sites in Newport Beach, Calif.; Springfield, Mo.; Knoxville, Tenn.; Nashville, Tenn., and Bloomington, Ind.
At least 92 late-stage melanoma sufferers were involved in the OU cancer study that was begun about 1998. Twenty eight patients were involved when the study was closed.
A report on the study showed that 37 patients died due to progression of their melanoma; one died due to stroke and three patients died of an unknown cause.
In the aftermath of the controversial study, OU drastically tightened research guidelines involving human subjects.
Meanwhile, a lawsuit involving several former study participants or their survivors has been filed against the school.
Raskob said OU has been sensitive to the needs of the patients continuing the shots. He said the FDA approval period for the continuation of the vaccine will expire in September.
When the last shot is administered, Raskob said the cancer survivors will be given detailed information on other cancer treatment options.