Cancer-drug trials give hope to dying

Desperate: Less than 5 percent of cancer patients in Phase I drug trials experience even partial tumor shrinkage, but patients are willing to try them anyway.

October 14, 2001|By JULIE BELL | JULIE BELL,SUN STAFF

Peggy Klang has let go of the hope that the experimental drug will save her from the tumor threatening her windpipe, or the others lodged in her abdomen, neck and lungs. Instead, she spends much of the energy she has left fighting pain and preparing for her own death.

Charles Sprenkle once hoped the same drug, being developed by EntreMed Inc. of Rockville, would help prevent a recurrence of the mouth cancer that resulted in the removal of part of his tongue.

But a cluster of cancer cells sprang up in his neck despite radiation and low doses of the drug, Angiostatin, taken in an early-stage test of its safety at Thomas Jefferson University Hospital in Philadelphia.

"I wish it had been a full-strength field trial," said Sprenkle, who believes stronger doses of the nontoxic drug might have helped him.

Klang, 48, and Sprenkle, 63, are two among tens of thousands of patients who this year will take unproven drugs in the human tests known as clinical trials.

Without the tests, new treatments wouldn't exist. Childhood leukemia still would kill every child who got it rather than a little over a third today. Testicular cancer, once spread, would claim nine out of 10 victims, instead of roughly one in 10. Deaths from Hodgkin's disease, a cancer of the lymph nodes, would occur at nearly three times the present rate.

It is these kinds of transformational results, achieved in increments over many years, that motivate most patients to enroll in early-stage trials like the one at Thomas Jefferson, experts say.

Many cancer patients view experimental drugs as more promising than proven treatments, studies show. They want the drugs to save their lives.

But the hard truth is that the great majority of patients in such initial tests won't benefit from experimental drugs.

Instead, cancer patients enrolling in Phase I trials, the first of the three human test phases required by the Food and Drug Administration, embark on an intensely personal journey that often results in the same outcome: death.

"Most of these patients are going to die," said Dr. Frederick J. Meyers, a cancer researcher at the University of California-Davis.

One reason: Patients generally enroll to take a single experimental drug only after established treatments haven't worked and their disease is far advanced.

In the trial at Jefferson, the patients aren't necessarily as sick. That test pairs Angiostatin with the approved treatment of radiation. Still, to get into the trial, the patients must be seriously ill - with their cancer advanced enough to require five to seven weeks of radiation to the head, neck, chest or pelvic area.

The trials - which entail multiple blood draws, CAT scans and urine samples designed to track the progress of a drug - can be a challenge to the endurance of sick patients.

Along the way, they and their families must navigate a bewildering system in which doctors double as cancer researchers and patients' bodies function as scientific data generators. Even the most sophisticated patients - accustomed to physicians concerned only about their well-being - may not fully grasp that they are being studied as much as treated.

"There's a disconnect between how physicians view Phase I and what patients' expectations are," said Dr. Jonathan D. Cheng, a researcher at Fox Chase Cancer Center in Philadelphia who has studied cancer patients' expectations.

Doctors design Phase I trials to assess a drug's safety and determine the proper dose for coming trials, not to help patients now. "Patients," he said, "want an effective cancer therapy."

Still, neither Klang nor Sprenkle regret enrolling.

"It wasn't really a waste of time," Klang said about the weekday infusions of Angiostatin at Thomas Jefferson. "I had to be there anyway for the radiation." Sprenkle, who once thought the drug would help him, now hopes it will help others.

"Obviously, with cancer, there should be a better way," he said, referring to the debilitating side effects that accompany the treatments now in routine use, "and, hopefully, Angiostatin is it."

Developing a cancer drug is a complex process, one being chronicled in The Sun as Angiostatin makes its way through the first phase of human testing. It takes the drive of committed scientists, the persistence of executives, the meticulous skills of doctors - and money. But it takes its ultimate contributions from those who initially benefit the least - patients.

Life before cancer

Klang's life before cancer had a comfortable rhythm. She rose each workday at 4 a.m. and watched a rerun of the late news while she drank her coffee. She walked her dog, Justa, and made her lunch. It was a 13-minute drive to the Cherry Hill, N.J., post office, where she sorted mail before delivering it.

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