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Posts with tag phase

Another attack on HER2 comes in form of vaccine

There are sometimes silver linings to the darkest of cancer clouds. I know -- because I have the dark cloud of HER2 positive breast cancer hanging over my head. HER2 positive means the tumor removed from my breast was aggressive. It aggressively over-expressed a protein that accelerates tumor growth. And it led to a poor prognosis -- that might be considered a good one too.

You see, research on the whole HER2 issue is turning up some pretty powerful potions. Like Herceptin -- the drug that miraculously cuts recurrence upwards of 50 percent for positive women like me. I was a lucky recipient of this drug. And the pharmacist who mixed the drug for all 17 of my infusions tells me it's really a good thing I have this HER2 problem -- because the drugs created to attack the problem may just cure me of my disease.

So in an odd turnabout -- from bad luck to good fortune -- I am not so sad my tumor was aggressive. It means there are bonus treatments for me. And if my cancer comes back and Herceptin no longer works, there is another drug called Tykerb. And now the Army is leading its own breast cancer vaccination study. The focus -- HER2.

Early study results from Walter Reed Army Medical Center in Washington, D.C. suggest a 50 percent reduction in disease recurrence for HER2 positive women who receive a vaccination of AE37.

AE37 targets HER2 and boosts the body's immune system so it can battle the protein before it stimulates growth. It's similar to Herceptin, but the activity of AE37 stimulates a patient's own immune system to recognize the cancer target rather than interacting with the target directly.

Should the Food and Drug Administration decide to support this study, it will proceed to Phase 3 testing, which includes a much larger pool of participants.

Cancer survivor's kit helps others keep on living

Survivorship is the new cancer buzz word -- and what an important word it is. Once left to each individual to define, manage, and transcend, survivorship is now recognized as a distinct phase of cancer recovery -- just as important, and maybe even more so, than diagnosis and treatment.

Linda Griggs, a 13-year breast cancer survivor, clearly remembers the day her chemotherapy ended. With her therapy complete, her hair growing back, and her medical team sending her off to have a nice life, she thought she'd be fine. But she wasn't.

Three months after her last dose of chemotherapy, Griggs was depressed, consumed with worry about how her cancer might come back. And she realized that the end of treatment is not really the end. It's just the beginning.

Griggs told her doctor about her anxiety, about how she was just trying to make it to her next three-month-check up. When her doctor told her, "that's not living," something clicked for Griggs who instantly decided to start living -- really living.

Surviving is about self-nurturing, says Griggs, who has created a kit to help others survive cancer. On her website, she writes that there are a couple of other breast cancer survivor kits out there -- containing tissues, herbal teas, meditation tapes, medical appointment books, and breast cancer resource materials.

"This is not that," she says of her kit that focuses on the emotional upheaval cancer creates.

Griggs' kit is full of hands-on creative materials -- like an inner child notebook, complete with magic markers for journaling and expressing emotions. If you're angry, you can write down angry thoughts. If you're sad, write what makes you sad. Save the pages, tear them up, burn them, do what you wish -- but allow your emotions to flow, Griggs says.

The kit also includes a wooden box with instructions on how to create a healing shrine, a copy of Griggs' non-fiction account of the first five years of her cancer journey, and so much more.

Griggs, who also teaches healing workshops, guides others to understand cancer as a hero's quest. She says when something happens to us -- death, divorce, disease -- we are receiving a call to adventure. All bet's are off. We must start fresh, gather our spirit guides, collect ourselves, dive into the underworld, overcome, and then emerge full of wisdom of growth.

Griggs has emerged -- full of her own wisdom and growth. She is a hero -- on a quest to help others survive a disease that threw her way off track for way too long.

CML patients that stop responding to Gleevec

Nilotinib is an investigational drug that targets the same protein as Gleevec, but through a different mechanism. Nilotinib, according to results recently presented at the 2006 meeting of the American Society of Hematology, is effective and well tolerated in patients with chronic-phase myeloid leukemia (CML) who do not respond to or cannot tolerate Gleevec.

In the past the only curative treatment for CML was a stem cell transplant. Researchers are focused on finding curative therapies that do not involve so much of a mortality risk and are more easily tolerated. A study was conducted to further evaluate the treatment with nilotinib in patients with CML who have stopped responding to Gleevec. Results of the study indicate that nilotinib was effective.

Xeloda reaches endpoint in phase III study

The latest Phase III study of Roche's cancer treatment Xeloda -- featuring 627 previously treated colorectal patients -- has reached its primary endpoint of progression-free survival.

Study results show that the chemotherapy combination XELOX (Xeloda plus oxaliplatin) was as effective as the combination FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin) in delaying disease progression -- a result that will be used in worldwide submissions of the drug.

Xeloda, an oral chemotherapy agent that can be taken at home, is already used in previously untreated colorectal cancer patients. It has also been approved for treatment of early stage colon cancer and for breast cancer that has spread to other parts of the body.

Phase III trial evaluating ALIMTA for treatment of extensive stage small cell lung cancer

Eli Lilly and Company has launched a major clinical trial evaluating ALIMTA (pemetrexed for injection) in extensive stage small cell lung cancer (SCLC), a devastating and rapidly spreading form of lung cancer. SCLC is sometimes called oat cell cancer because small cell lung cancer cells resemble oat grains. Patients with SCLC are staged according to a two-stage system, being diagnosed as having either limited stage disease or extensive stage disease. About 65 to 70 percent of patients with SCLC are diagnosed with extensive stage disease and the current two year survival rate is less than 10 percent.

The GALES trial, Global Analysis of Pemetexed in SCLC Extensive Stage, is a Phase III trial that will enroll 1,820 patients with extensive stage disease. The study's primary objective is to compare the overall survival after treatment with pemetrexed plus carboplatin verses the current standard treatment of etoposide plus carboplatin.

More details on the study design and information on global recruitment sites may be found at www.clinicaltrials.gov and www.lillytrials.com or by calling 1-877-CTLILLY.

Clinical trial tests common virus to treat malignant brain tumors

Malignant glioma is the most common primary brain tumor. The outlook for patients with malignant glioma is poor. Median survival for patients with grade III glioma is three to five years and less than one year for the most aggressive form of malignant glioma called glioblastoma multiforme.

The virus or reovirus that the researchers are focusing on is a common virus in humans that inhabits the lungs and intestines. The researchers added that this virus is something that most humans have been exposed to by adulthood but demonstrates no illness or negative effects on us.

When the virus is exposed to the malignant glioma cells it appears to infect and kill the tumor cells. Dr. James M. Markert, M.D., professor and director of the division of neurosurgery at the University of Alabama at Birmingham (UAB) and lead investigator of the trial explains "Healthy, non-cancerous cells in our bodies have the ability to prevent the reovirus from replicating, so that even if we are infected with the virus we do not usually exhibit significant symptoms but brain tumor cells do not have that protection, due to a mutation in their DNA. The reovirus replicates, destroying the tumor cell, and the replicated virus goes in search of new tumor cells to infect". So not only will the main tumor be destroyed but the virus could potentially be effective against glioma cells that have begun to spread away from the primary tumor to other parts of the brain.

The phase one clinical trial will enroll fifteen patients that have recurrent malignant glioma. The patients will have a brain surgery procedure that infuses the reovirus through two catheters that are placed on the tumor mass.

The main purpose of this study is to determine whether the virus is safe to administer to humans. It has shown in previous studies to be well tolerated and not have any negative side effects. This research sounds very exciting to me since this disease is very hard to treat. I know too well, as my uncle was diagnosed with a brain tumor and died just over a year from diagnoses before he turned forty. This was in 1987. The prognosis since that time really hasn't changed for malignant glioma. I hope this is something that can give the patients diagnosed much more hope of a longer survival.

The Rack Pack strives to support friend with breast cancer

Glamour's October magazine features stories about breast cancer survivors. Cancer Vixen Marisa Acocella Marchetto, cartoonist for Glamour and The New Yorker and author of Cancer Vixen: A True Story, is profiled. And another survivor -- young mom Kelly Corrigan who authors her online journal Circus of Cancer -- is highlighted. And Allison Briggs, diagnosed with breast cancer at the age of 26, shares her photo journal with readers who learn from all three survivors that more and more, women are sharing their cancer journeys in very public ways.

Allison -- Alli -- could not sleep the night she was diagnosed with breast cancer so she sent her boyfriend to the store for medication to calm her upset stomach. While he was gone, she noticed a camera sitting on the bedside table. She had an overwhelming urge to start snapping photos. So she took some self-portraits, had her boyfriend take some more when he returned home, and decided that night she would document her journey through photographs. She wanted to remember this phase of her life -- even though she had no idea how it would turn out.

Life is turning out just fine for Alli, who has rallied a support team called The Rack Pack, a group of women who aim to make a difference -- all because of the inspiration and strength they receive from their friend Alli. They are participating in the Susan G. Komen Breast Cancer 3-Day, 60-mile walk in San Diego November 10-12. They sell Rack Pack t-shirts. They offer e-mail notification of exclusive Rack Pack events. They share updates about Alli. They never stop trying to make a difference -- for Alli and for women everywhere fighting breast cancer.

Glioblastoma Multiforme phase III trial does not improve survival

Glioblastoma Multiforme is usually only has a survival rate up to one year after diagnosis. This primary brain tumor's standard treatment is surgery to remove as much as the cancer as possible, radiation and or chemotherapy. Even with the most aggressive forms of treatment the patients do not survive.

Researchers are trying to improve survival of patients diagnosed with Glioblastoma. The results of a phase III clinical trial published in the Journal of Clinical Oncology tried to improve survival rates by using a treatment consisting of cisplatin, carmustine and radiation therapy. Unfortunately this regimin produced more adverse side effects and did not improve survival.

My uncle died of a brain tumor. He died in 1987. I do not think that this disease has any better cure rate then it did back then. He died a little over a year after he was diagnosed. It doesn't seem that chemotherapy or radiation works for this type of cancer but it's all we got so we try new combinations.

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