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Old 02-09-2009, 07:19 PM   #1
eric
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'Targeted Chemo' Safely Shrinks Liver Tumors

http://abcnews.go.com/Health/Cutting...6803208&page=1
Linda Campbell had already beaten ocular melanoma, a rare form of skin cancer, or so she thought. Then during the summer, doctors discovered the tumors had spread to her liver.
"There were so many they couldn't count them," said Campbell.
Campbell, who's 59 years old and lives with her husband outside of Lexington, N.C., learned that when cancer spreads to the liver, it becomes much more deadly.
It does not matter whether cancer starts in the breast or colon, lung or skin, the real damage is caused when it metastasizes to the liver. Every year an estimated 200,000 Americans receive the grim diagnosis and few patients survive more than a year.
"There was a lot of crying. ... And we weren't sure what to do," Campbell told ABC News.
Doctors suggested Campbell enroll in a clinical trial testing a new, radically different type of chemotherapy. This experimental technique targets only the cancer site, allowing doctors to flood the liver with 10 times the dose of a standard chemotherapy drug.
"You can perhaps get a better effectiveness, which would improve the longevity of the patient and the quality of life," said Dr. H. Richard Alexander of the University of Maryland Medical Center in Baltimore, Md., one of several now conducting clinical trials on this technique.
"Anytime you get a dose of chemo intravenously, even a teaspoon, it's going to be distributed through the entire body," Alexander said. "You are only going to get a drop or a fraction of a drop into the tumor where you really want it. But if you can direct a teaspoon of chemotherapy to a region of the body where the cancer is actively growing, then you are going to get a much higher dose of that potentially effective chemotherapy directly to the tumor."
The challenge: how to do it safely. Now, doctors say they've found a way.
In this protocol, doctors thread a catheter up to the liver and for the next 30 minutes inject the high doses of the chemotherapy drug directly to the site. To prevent the drug from reaching the rest of the body, doctors "capture" the blood -- now loaded with the chemo drug -- as it leaves the liver. The blood is passed through an external filter then safely returned to the body.
"We can very effectively capture almost all of the blood containing chemo as it comes out of the liver," said Alexander.
In a recently completed Phase I clinical trial, after four monthly treatments, liver tumors shrank in 50 percent of patients. In two patients, the tumors actually disappeared.
And early indications are Campbell's liver tumors have started to respond, and with few side effects.
"I'm surprised at how good I feel afterwards," she said. No hair loss or nausea. Some fatigue and appetite loss appear to be the biggest complaints.
Campbell does not know if, or when, her cancer will start growing again, but she knows the "targeted chemo" could provide precious time.
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Old 02-10-2009, 01:28 PM   #2
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Interesting. I guess the filtering of blood exiting the liver is what makes it different from existing directed chemo to the liver.
I wonder if they have settled on a name for this protocol.
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Old 02-10-2009, 01:32 PM   #3
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http://www.the-dispatch.com/article/...05/1053/SPORTS


Local woman participating in promising clinical trial


By VIKKI BROUGHTON HODGES
The Dispatch


Published: Tuesday, February 10, 2009 at 9:00 a.m.
Last Modified: Tuesday, February 10, 2009 at 9:08 a.m.
A High Rock Lake resident is a participant in a national clinical trial that is giving hope to the estimated 200,000 Americans diagnosed with liver cancer each year.

.art_main_pic { width:250px; float:left; clear:left; }
Click to enlarge
Linda Campbell (left) and her daughter, Lisa Campbell-Taylor, stand in front of a display of homemade Valentine's Day cards in their shop, Peanut Doodles, which is in Lakeside Village in Southmont.
Vikki B. Hodges/The Dispatch


Want to know more?
For more information, visit livercancertrials.com. To see the 'ABC News' news clip and video of how the process works, go to abcnews.go.com/
Health/Cutting Edge/story?id=
6803208&page=1.




Click to enlarge
Lab assistant Hether Ashby (left) draws blood from Linda Campbell on Monday at Lexington Memorial Hospital. Campbell has bloodwork done twice a week at LMH to monitor her hemoglobin and red and white blood cell counts, among other things, as she participates in a national clinical trial on treating liver cancer.
Vikki B. Hodges/The Dispatch


Linda Campbell, 59, was diagnosed with liver cancer in July 2008. She had already beaten ocular melanoma, a very rare form of skin cancer, in 2000 and a recurrence in 2006. But a routine CT scan of her liver this past summer found that the cancer had metastasized to the organ. An MRI confirmed that her liver was "riddled" with numerous peppercorn-size tumors and two marble-size ones.
Campbell said she didn't hesitate to participate in the trial.
"I knew it was my best chance to survive," she said. "If you do nothing, you might live a year if you're lucky."
Campbell was featured last week on "ABC News" about her participation in a Phase III clinical trial at the University of Maryland Medical Center, one of about a dozen trial sites, in which a targeted drug delivery system allows doctors to deliver significantly higher doses of anti-cancer drugs to the site of disease without exposing the patient's entire body to those same high levels.
In Campbell's case, her liver is receiving 10 times the amount of a standard chemotherapy drug than would be used in systemic cancer therapies that are given intravenously and go to all parts of the body. The targeted therapy has shown that getting more of the drugs to the tumor site - and less to the rest of the body - increases the rate of tumor shrinkage and improves quality of life by lessening the usual side effects such as nausea and hair loss.
Campbell said the targeted therapy is done by threading a catheter to the liver and injecting the high dose of the chemotherapy drug directly into the organ for the next 30 minutes and then capturing the blood as it leaves the liver. The blood is then filtered to remove the chemo and returned to the body.
But the treatment is much more involved than a half-hour process. Every five weeks Campbell and her grown daughter, Lisa Campbell-Taylor, drive to Baltimore for the treatment.
The night before the chemotherapy, Campbell is hydrated intravenously to better tolerate the chemo.
"The filter gets the chemo out of the liver, but it takes everything out, the good and the bad, so they have to put some things back in," she said, adding that she is ready to return home the next afternoon.
Campbell said the first treatment hit her the hardest and was the highest dosage she has received. But the second and third treatments were much easier for her to tolerate, with some fatigue the only side effect.
"I would come home and feel tired but also feel great," she said.
Campbell returns for her fourth treatment next week.
Dr. H. Richard Alexander Jr. in Baltimore, who is running the clinical trial, said the recently completed Phase I clinical trial showed that after four monthly treatments, liver tumors shrank in half of the patients. Two patients actually had their tumors disappear.
"Phase I was a small number of patients, about a dozen, but the results were so striking we went to the FDA and said we'd like to go straight to the definitive Phase III treatment," said Alexander, who began his research several years ago at the National Institutes of Health. "And they agreed to that because of the results we got."
It could still take another year to 18 months for final Food and Drug Administration approval for the now experimental treatment, Alexander said. More patients continue to be enrolled in the Phase III trial.
"It's been deemed safe, but this stage is to verify its effectiveness," he said.
Alexander said a scan of Campbell's liver in the initial treatment stage showed encouraging tumor shrinkage. Before treatment, the small tumors were so close together and overlapping that it was hard to distinguish them.
"I'm very optimistic," he said.
Campbell credits Alexander, as well as her local oncologist, Dr. William Black of Carolina Oncology Associates in Salisbury, and many other medical professionals who have treated her over the past nine years. She noted it's a team effort, too. She has bloodwork done twice weekly at Lexington Memorial Hospital to monitor her white and red blood cell counts and hemoglobin levels, among other things. If she needs a blood transfusion, she goes to Rowan Regional Medical Center, which Black is associated with. She had been referred to Alexander by a surgical oncologist at UNC Hospitals in Chapel Hill.
When she was diagnosed with ocular melanoma by a retina specialist in 2000 at the National Naval Medical Center in Bethesda, Md., she was referred to a specialist at Will's Eye Institute in Philadelphia, which specializes in ocular oncology and related conditions of the eye. She and her husband, Hugh, lived in McLean, Va., at the time, before he retired from the U.S. Coast Guard; they moved to High Rock Lake about two and a half years ago to be closer to their daughter and her husband, Perry Taylor, an engineer for Richard Childress Racing.
"I tell people to research and find the best possible doctors in their area," she said. "I've been so lucky. I've had the best doctors you could possibly have.
"They've all said don't give up. Their positive attitude has been very helpful."
Campbell said she also tells everyone that follow-up care and exams are crucial once you've been diagnosed with any form of cancer because of the way it can silently spread. Doctors knew that ocular melanoma can spread to the brain and liver, so she received annual scans, which is how her liver cancer was discovered, not because of any symptoms.
"Follow-up is so important," she said.
Campbell said people should also make sure they have annual eye exams. She said she only knew something was wrong in her eye because the tumor was in her line of vision and started to affect her sight. She noted that most ocular melanoma tumors are to the side of the eye, and people may have no symptoms or vision problems for years, during which time the tumors grow and become more deadly.
"You have to be your own best advocate, too," said Hugh Campbell. "You have to keep asking questions."
When Campbell and her daughter go to Baltimore, Hugh and Perry take care of their business, Peanut Doodles, a scrapbooking, card making and art supply business in Southmont the mother, daughter and son-in-law opened in June 2008. They also take care of the shop's two mascots, Peanut, for whom the business is named, and Buttercup.
"My family has been wonderful," she said. "And this store really keeps me going. It gives me a reason to get up and come in every day. We've met so many people through the store, and everyone has just been wonderful."
Campbell said she is very encouraged by preliminary results but also realistic.
"I will be going up there and be monitored the rest of my life," she said. "It's a lifestyle thing. I just hope it prolongs my life a good long time.
"I know it's not a cure, but it's buying me time, and I'm hoping they find a cure."
Vikki Broughton Hodges can be reached at 249-3981, ext. 214, or at vikki.hodges@the-dispatch.com.
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Old 02-10-2009, 01:36 PM   #4
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http://www.umm.edu/general_surgery/b....htm#Alexander

"Dr. Alexander is recognized for developing innovative techniques to treat patients with advanced cancers of the gastrointestinal tract, especially the liver. One example is isolated hepatic perfusion, a way to circulate high doses of chemotherapy directly into the liver to treat patients with inoperable cancer. With this "closed loop" technique, only the liver is exposed to the chemotherapy, protecting other organs and minimizing the side effects of treatment."
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Old 02-10-2009, 01:39 PM   #5
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Surg Oncol Clin N Am. 2008 Oct;17(4):857-76, x. Links
Development of isolated hepatic perfusion for patients who have unresectable hepatic malignancies.

Jones A, Alexander HR Jr.
Department of Surgery, University of Maryland School of Medicine, 22 South Greene Street, Baltimore, MD 21201, USA.
Isolated hepatic perfusion (IHP) has a role in the treatment of colorectal carcinoma, ocular melanoma, and neuroendocrine tumor liver metastases. Outcomes data with IHP have improved with better patient selection, adoption of standard operative techniques, use of appropriate types and doses of chemotherapeutics, and careful measures of efficacy and survival. The percutaneous approach to IHP, the treatment of additional tumor types (eg, unresectable hepatocellular carcinoma, gastrointestinal sarcoma, occult primaries), the use of other agents within the IHP circuit, and gene therapy all deserve additional attention.
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Old 02-11-2009, 06:31 PM   #6
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Is it only being done in Maryland?
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Jan04: Bilateral Mastectomy at age 28
Initial DX: Left Breast: IDC 2cm, Grade 3, HER2+3, 0 Nodes +, ER/PR-. Right Breast: Extensive DCIS ER-/PR+; Stage 1-2a
Feb04-Apr04: 4 AC, dose dense
Aug 04: 4 Taxotere
Dec 05: Bone and Liver METS; Stage 4. Carboplatin/Taxol/Herceptin. DX with Li-Fraumeni Syndrome
Apr 06: NED, maintenance Herceptin
Apr 07: CA1503=14; masses in liver; Xeloda/Tykerb
Nov 07: NED, Tykerb maintenance
Sept 08: Liver mets again, on Tykerb/Xeloda again, CA=19 and 27
Nov 08: Progression, Tykerb/Gemzar, CA=25
Dec 08: Progression, Herceptin/Navelbine, CA=40, 57, and 130
Jan 09: Progression in bone, recession in liver, Herceptin/Carbo/Abraxane CA=135
June 09: CA27/29=24, chemo break
Sept 09: Progression, CA=24, waiting on clinical trial (4 weeks no treatment)
Nov 09: now have brain mets, trial "on hold", getting 14 WBR treatments starting 11/2/09
Dec 09: possible start on p53 trial
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Old 03-01-2009, 10:28 PM   #7
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"the University of Maryland Medical Center, one of about a dozen trial sites"

Could call Dr. H. Richard Alexander to find out about other sites or hub of research:
Contact Information:
1-800-373-4111 (physicians only)
1-800-492-5538 (patients and general information)
1-410-328-8919 (news media only)
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Old 03-02-2009, 06:58 AM   #8
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Rich - I'm hoping your timing turns out to be a blessing since I had forgotten about this and just sent it off to Caryn's Onc. If her liver isn't strong enough to filter on it's own, this seems to me to be an option to at least target the liver as a first step.
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Old 03-02-2009, 02:24 PM   #9
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U of Maryland pointed me to this site, the company that makes the catheter used and is sponsoring trials:
http://www.delcath.com/
Haven't come across trials with MBC but arms might be twistable.
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Old 03-02-2009, 03:03 PM   #10
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A site that focuses on the trials:
http://www.livercancertrials.com/
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Old 08-08-2010, 10:37 PM   #11
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Re: 'Targeted Chemo' Safely Shrinks Liver Tumors

I'm being treated by the VA for a 2.5 cm tumor. I have cirrosis and hep-c from my time in Viet Nam. (touching enormous amounts of blood and taking a bath in Agent Orange, basically. Unfortunately the VA is short on Doctors so I tried to get referred to Emory but the VA won't refer me there. I don't know what the problem is. I only have medicare part A but not B or I would go to Emory on my own. What does a person have to do to get into one of the IHP trials near Athens or Atlanta,Ga.. My understanding is I really need a liver transplant but first the VA has told me they'll probably send me to Birmingham, Ala. for radiation treatment to kill the tumor then if I can get on a transplant list to a VA in Nashville for a transplant ........ if I make it that long. They discovered the tumor in a Feb. 2009 cat scan, according to my records, but I've been feeling like heck for longer than that. This new type treatment sounds like a "God" send!" My son has spinal-bifda and my daughter has diabetes. They need their dad to be as close as possible, while getting treatment and a few more years! What must I do to qualify?

Last edited by Steve Bailey; 07-06-2011 at 09:31 PM.. Reason: Found paper work indicating my post needed revising!
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Old 06-24-2011, 06:26 AM   #12
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Re: 'Targeted Chemo' Safely Shrinks Liver Tumors

Can anyone give us an update on these trials? This type of treatment sounds like it could have a major impact on the way cancer is treated and it would seem to me to have the potential to save and improve the quality of many lives. I am curious if this treatment has yet been accepted or considered as standard treatment. I am wondering if anyone has been to Dr. Robert Goulet? Would you recommend him?
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Old 06-24-2011, 09:52 AM   #13
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Re: 'Targeted Chemo' Safely Shrinks Liver Tumors

Looks like still trialing in other cancers. Delcath FDA filing refused Feb 2011.
Other options for liver here:
http://her2support.org/vbulletin/sho...053#post221053
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Old 06-27-2011, 08:22 AM   #14
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Re: 'Targeted Chemo' Safely Shrinks Liver Tumors

Thank you.
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Old 05-08-2012, 08:58 AM   #15
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Re: 'Targeted Chemo' Safely Shrinks Liver Tumors

Can you give me further info on the treatment in Maryland? On Herceptin/Tykerb 1500 and not working, tumors in liver doubling in size
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Old 05-08-2012, 09:06 AM   #16
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Re: 'Targeted Chemo' Safely Shrinks Liver Tumors

Been following this but doesn't seem to be available yet. Other liver directed therapies:

Liver mets (various established and evolving ablation techniques)

http://her2support.org/vbulletin/sho...053#post221053
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