Cediranib for Androgen-Independent Prostate Cancer

Name of the Trial
Phase II Study of AZD2171 in Patients with Metastatic Androgen-Independent Prostate Cancer (NCI-07-C-0059). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-07-C-0059.

Principal Investigators
Dr. William Dahut and Dr. William Figg (Protocol Chair), NCI Center for Cancer Research

Why This Trial Is Important
Advanced prostate cancer is often dependent upon male hormones (androgens) for continued growth and may initially respond to anti-androgen therapy. Unfortunately, prostate cancer growth ultimately becomes androgen-independent. Treatment with the chemotherapy drug docetaxel may help men with androgen-independent prostate cancer survive longer, but, if the cancer becomes resistant to docetaxel, there currently are no other proven effective treatment options.

One strategy being tested for treating metastatic, androgen-independent prostate cancer is to block the blood supply that feeds the tumors. A large body of research indicates that solid tumors need to develop new blood vessels (a process called tumor angiogenesis) in order to keep growing and that attacking the tumor blood supply may inhibit further growth and spread. Some studies suggest that metastatic prostate cancer may be especially dependent on tumor angiogenesis.

A drug called cediranib blocks the action of vascular endothelial growth factor (VEGF), a protein that plays a crucial role in tumor angiogenesis, by attaching to VEGF receptors on cancer cells. Cediranib treatment, therefore, may be able to block prostate tumor angiogenesis and inhibit prostate tumor growth.

In this trial, men with metastatic, androgen-independent prostate cancer whose cancer has continued to progress on docetaxel will take oral cediranib daily. Treatment will continue for those patients whose tumors do not progress and who do not suffer unacceptable side effects. Doctors want to see if cediranib can help delay the progression of cancer in these patients.

“There are a number of drugs that block the action of VEGF being tested in metastatic, androgen-independent prostate cancer, but each drug works differently,” said Dr. Dahut. “Cediranib looks to be a promising agent because it blocks more VEGF receptors than other drugs in the class, potentially making it a more effective inhibitor of tumor angiogenesis.”

For More Information
See the list of eligibility criteria and contact information at http://cancer.gov/clinicaltrials/NCI-07-C-0059 or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The call is toll free and confidential.

Source: NCI Cancer Bulletin.  April 29, 2008

Herbal Therapy for Brain Cancer

Name of the Trial
Phase II Randomized Study of Adjuvant Boswellia Serrata and Standard Treatment Versus Standard Treatment Alone in Patients with Newly Diagnosed or Recurrent High-Grade Gliomas (CASE-CCF-7348). See the protocol summary at http://www.cancer.gov/clinicaltrials/CASE-CCF-7348.

Principal Investigator
Dr. Glen Stevens, Cleveland Clinic Foundation

Why This Trial Is Important
High-grade gliomas are among the most common and aggressive forms of adult brain cancer. Swelling of the brain (brain edema) is an often debilitating symptom of glioma and may continue to affect patients even if the tumor is surgically removed.

Resin from the Boswellia serrata tree (frankincense) has been shown in animal and human studies to reduce inflammation, which is a primary cause of brain edema. Additionally, laboratory studies suggest that B. serrata resin may also cause human brain cancer cells to undergo programmed cell death (apoptosis).

In this trial, patients will be randomly assigned to take an herbal preparation of B. serrata orally four times a day in conjunction with standard treatment for six months or to take standard treatment alone for six months. All patients are advised to eat a low-fat healthy diet. Diets rich in red meat contain a substance called arachidonic acid, and chemicals in fat can be converted to arachidonic acid. Arachidonic acid is converted in the brain to signaling molecules called eicosanoids that may promote inflammation and tumor growth. Doctors want to see if B. serrata can help reduce brain edema, tumor growth, and levels of 5-lipoxygenase, an enzyme that helps convert arachidonic acid to eicosanoids, in these patients when combined with standard treatment.

“Some small studies have suggested that frankincense extract may help limit brain edema and even have an anti-tumor effect,” said Dr. Stevens. “We hope that use of this herbal preparation in conjunction with a healthy diet will help improve patient outcomes and act in a complementary fashion with standard treatments for high-grade gliomas.”

For More Information
See the lists of entry criteria and trial contact information at http://cancer.gov/clinicaltrials/CASE-CCF-7348 or call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.

Source: NCI Cancer Bulletin.  April 15, 2008

Batracylin for Patients with Advanced Solid Tumors or Lymphoma

Name of the Trial
Phase I Study of Batracylin in Patients with Metastatic or Unresectable Solid Tumors or Lymphoma (NCI-07-C-0097). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-07-C-0097.

Principal Investigator
Dr. Martin Gutierrez, NCI Center for Cancer Research

Why This Trial Is Important
Scientists have made great strides in determining how certain proteins contribute to cancer formation, growth, and spread. As a result, the development of drugs that target these proteins has become a major focus of cancer research.

Along with the development of such targeted therapies, researchers have explored the possibility of matching the genetic characteristics of patients to treatments that may be especially suited to them. The drug batracylin is an example of a targeted therapy that may prove beneficial to patients with certain genetic characteristics.

Batracylin inhibits two proteins, topoisomerase I and topoisomerase II, that are overabundant in certain types of cancer cells and may play a role in cancer formation and progression. Drugs have been developed that target one or the other of these proteins, but batracylin is the first drug to reach human clinical trials that targets them both.

Although this ability makes batracylin a promising anticancer agent, early testing in animals indicated that different species process the drug differently, with some species processing it very quickly, resulting in unacceptably severe side effects. Subsequent research showed that a cellular process called acetylation occurs more rapidly in these species, causing them to process batracylin more quickly. This finding led researchers to theorize that humans whose genetic characteristics cause slow acetylation would be able to tolerate and benefit from treatment with batracylin.

In this trial, patients with solid tumors or lymphomas for which standard therapies do not exist or are of minimum benefit and who are slow acetylators, as determined by a blood test, will be treated with increasing doses of batracylin. Researchers hope to assess the pharmacokinetics of batracylin in these patients and determine the most appropriate dose for future clinical trials.

For More Information
See the list of entry criteria and trial contact information at http://cancer.gov/clinicaltrials/NCI-07-C-0097 or call the NCI Clinical Trials Referral Office at 888-624-1937. The call is toll free and confidential.

Source: NCI Cancer Bulletin. April 1, 2008