UM’s clinical trial for new bladder cancer drug shows promise

Robert’s bladder cancer had spread throughout his body, causing great pain and significant weight loss. Worse, he wasn’t responding to chemotherapy.

“I was ready to let him go,” Alice said. “We were to that point.”

Then, in the spring, he found out about a proposed clinical trial at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. A new drug, developed by the university’s Dr. Andrew Schally, a Nobel Prize-winner, was ready for its Phase I/II testing.

Chambers, 64, a one-time entertainment director for a series of Atlantic City casinos, was diagnosed with bladder cancer in 2007. He would be the first patient to try the new drug.

There would be six appointments spread three weeks apart to intravenously dispense the drug into his arm.

“When you enter a clinical trial you don’t think of curing yourself,” Chambers said Tuesday from a bed at Sylvester with his wife by his side. A Kindle rested at his feet loaded with Siddhartha Mukherjee’s 2011 Pulitzer-winning novel, The Emperor of All Maladies: A Biography of Cancer.

“This particular trial is for people who are at their end game, so you’re at that point mentally resigned to whatever’s going to happen,” he said. “If it’s something that can be beneficial to other people down the road, I think it’s a good thing to do.”

Of course, Chambers allows that he harbored thoughts of curing himself but, “being the first one, with no track record, it’s rolling the dice, really.”

Call him a winner so far.

Doctors are excited with the results of the trial. His pain was gone three weeks after his first treatment in May. His cancerous growths have been reduced by 70 percent after five treatments.

“After the second infusion, I was feeling a lot better and palpable things were changing,” Chambers said. “I could feel a tumor in the lymph node of my neck. After the second treatment, it was gone. That was my first indication that this thing was actually working.”

At first, after so many setbacks, Chambers, a former smoker, was afraid to believe he might finally be on top of the cancer, his wife said.

“He’d been through so much that didn’t work,’’ she said. “This had to work.”

Tuesday, he sat for his sixth and final infusion.

“When he came here, he had failed chemotherapy,” said UM oncologist Dr. Gustavo Fernandez, who is leading the trial and treating Chambers. “There was no hope. No other options. Literally, he was dying of cancer.”

Today, “his quality of life has changed dramatically. The cancer is shrinking and we are very happy about that,” Fernandez said.

The dual-action drug works by targeting the cancer cells and acting like a missile to destroy them, Fernandez explained.

“The drug has two components, a protein part and a chemotherapy part. The protein portion binds to the cancer cell’s receptors and gets internalized inside the cells. When the drug is internalized, then the chemo part gets inside the cell and destroys the cancer cells.”

Side effects are greatly reduced as compared to traditional chemotherapy which can lead to severe nausea and hair loss.

Chambers suffers from urothelial carcinoma, the most common type of bladder cancer in the United States, affecting about 70,000 people annually. The cancerous cells attack the innermost lining of the bladder wall. In a majority of these cases, when caught early, the cancer doesn’t metastasize in other parts of the body and it can be removed by surgery or less-invasive approaches. But Chambers’ cancer had metastasized and proved resistant to traditional treatment. “When chemo fails, we don’t have any other option to offer patients. That is the reason for the clinical trial of the new drug,” Fernandez said.

The FDA approved the Phase I/II clinical trial for six infusions only.

“If we can continue this treatment, we will do it. If not, we’ll watch the patient closely. We know the cancer is shrinking. We may have to do another CAT scan to see how the cancer has decreased from last time,” Fernandez said.

Schally, chief of the UM’s Endocrine, Polypeptide and Cancer Institute, began his work on the drug two decades ago while working in New Orleans. He won a Nobel Prize in 1977 for his discovery that the brain produces luteinizing hormone-releasing protein. Then he combined this protein with a chemotherapy agent to form a drug, AEZS-108, against bladder cancer.

“It took him eight years to figure out how to connect the two pieces,” said Dr. Norman Block, a UM professor of pathology, urology, oncology and biomedical engineering.

After Hurricane Katrina displaced Schally six years ago, Block convinced his pal to work at the UM.

Block represented Schally at the hospital Tuesday because his 84-year-old colleague was on his honeymoon in Bora-Bora.

“He’s on his third wife and third honeymoon and third vacation trip. He never takes vacation except to get married,” Block teased.

But Block said Schally is thrilled with the results of his drug at this stage.

So are the Chambers, who live in West Palm Beach. The couple have two grandchildren.