Oncology NEWS International Vol 15 No 10

>Calypso 4D Localization System Measures Prostate Movement During Radiotherapy

October 01, 2006

Calypso Medical Technologies, Inc.'s Calypso 4D Localization System has been granted 510(k) clearance by the FDA to locate the tumor target during treatment setup and monitor organ motion continuously during radiation therapy for prostate cancer patients, without adding ionizing radiation.

Recombinant MAGE-A3 Cancer Immunotherapy Promising

October 01, 2006

A recombinant fusion protein designed to stimulate immune response against the MAGE-A3 tumor antigen has shown some efficacy in patients with completely resected early-stage non-small-cell lung cancer (NSCLC), decreasing the recurrence rate by about one-third.

WHI Calcium/Vit D Trial:

October 01, 2006

Attendees at the 42nd Annual Meeting of the American Society of Clinical Oncology were eager to learn whether calcium and vitamin D supplementation has beneficial effects on breast cancer, mammograms, and arthralgias.

FDA Approves Vectibix for Metastatic Colon Ca

October 01, 2006

The US Food and Drug Administration (FDA) has approved Amgen's Vectibix (panitumumab) for the treatment of patients with colorectal cancer that has metastasized following standard chemotherapy.

NCCN Presents Hematologic Ca Congress

October 01, 2006

World-renowned thought leaders discussed important clinical advances and new guidelines in the diagnosis and treatment of hematologic malignancies, at the first annual National Comprehensive Cancer Network (NCCN) Hematologic Malignancies Congress.

Interim Results for MediGene's Oncolytic Virus NV1020

October 01, 2006

MediGene AG has announced that the interim analysis of a phase I/II trial of its oncolytic herpes simplex virus NV1020 has shown efficacy for the treatment of liver metastases in patients with colorectal cancer. Therefore, the trial will continue as scheduled, with the maximum dosage of the virus. The agent is delivered to the liver at weekly intervals through the hepatic artery. All patients receiving the maximum dosage demonstrated either disease stabilization or a clear regression of liver metastases, the company said in a press release, adding that some patients showed regressing metastases in other organs as well.

GSK Files NDA for Tykerb for Advanced Breast Cancer Rx

October 01, 2006

GlaxoSmith-Kline (GSK) has announced the submission of a New Drug Application to the US Food and Drug Administration (FDA) for approval to market Tykerb (lapatinib ditosylate), in combination with capecitabine (Xeloda), for the treatment of advanced or metastatic HER2-positive breast cancer

Interim Data Show Satraplatin Efficacy in Advanced Prostate Ca

October 01, 2006

GPC Biotech AG and Pharmion Corporation have announced positive results for the companies' oral platinum agent satraplatin in an interim analysis of the double-blind, randomized phase III registration trial.

ODAC Suggests Abraxane Efficacy Study as Adjuvant Rx

October 01, 2006

The Oncologic Drugs Advisory Committee (ODAC) has recommended that FDA work with Abraxis Bioscience to design a well-controlled, randomized, reasonably sized clinical trial of Abraxane-paclitaxel protein-bound particles for injectable suspension (albumin bound)—to support a future supplemental application for the drug as an alternative to standard paclitaxel (Taxol) in the adjuvant treatment of node-positive breast cancer.

Adjuvant Chemotherapy Improves Survival for Stage II and III NSCLC, but Not for Stage IB, Studies Suggest

October 01, 2006

Use of adjuvant chemotherapy for stage IB non-small-cell lung cancer (NSCLC) is less certain than it appeared to be at last year's American Society of Clinical Oncology (ASCO) meeting, according to a study reported at the 2006 ASCO Annual Meeting.

Grant Launches Starr Cancer Consortium

October 01, 2006

The Starr Foundation, one of the largest private foundations in the United States, has launched the multi-institutional Starr Cancer Consortium with a $100 million grant to coordinate the research efforts of five internationally recognized cancer research centers.

Noxafil Approved for Prevention of Aspergillus Infection

October 01, 2006

The US Food and Drug Administration (FDA) has approved Schering-Plough Corporation's Noxafil (posaconazole) Oral Suspension for the prevention of invasive Aspergillus and Candida infections in patients age 13 years and older at high risk of developing these infections.

'Death Receptors' Are New Targets for Cancer Treatment

October 01, 2006

A new bioengineered protein that targets two apoptosis receptors produced one dramatic tumor regression and stopped tumor growth in several cases of disease stabilization in 60% of the advanced cancer patients treated in a phase I dose-finding trial

Therapeutic Interventions Benefit Kids of Parents With Ca

October 01, 2006

A research-based psychosocial intervention especially geared to the needs of children whose parents have cancer is of great benefit, offering emotional support at a time when their fears can be overwhelming

Predictive System Incorporates Multiple Prognostic Markers

October 01, 2006

Researchers are using large patient datasets and computer programs to develop an expanded cancer staging system, moving beyond the conventional three markers—tumor size, nodal involvement, and metastasis—used in TNM staging. The new system, presented at the International Union Against Cancer's World Cancer Congress, uses TNM stage and other factors, such as histology and tumor grade, to fine tune and personalize prognosis

Systematic Approach Can Manage Erlotinib Skin Toxicity

October 01, 2006

A systematic approach to early treatment of skin toxicity in patients on erlotinib (Tarceva)-based therapy can reduce the need for dose modification or delay in patients with head and neck cancer or non-small-cell lung cancer (NSCLC)

ODAC Votes No on Genasense Accelerated Approval for CLL

October 01, 2006

The Oncologic Drugs Advisory Committee voted 7-to-3 against recommending accelerated approval for Genasense (oblimersen sodium, Genta) to treat relapsed/refractory chronic lymphocytic leukemia (CLL) in combination with fludarabine (Fludara) and cyclophosphamide.

Small Estrogen Doses Fight Drug-Resistant Tumor Cells

October 01, 2006

a new treatment model for breast cancer to reverse the eventual development of resistance to antiestrogen therapy, including an intriguing strategy that involves the use of very small doses of estrogen itself

Methylphenidate May Reduce Fatigue in Prostate Cancer

October 01, 2006

Methylphenidate (Ritalin) effectively reduces fatigue in men with prostate cancer; however, careful monitoring is essential because the psychostimulant can also elevate blood pressure and pulse rates

Polymorphism Affects Response to, Toxicity of Irinotecan Rx

October 01, 2006

A polymorphism that reduces the hepatic metabolism of irinotecan (Camptosar) and that is present in about half of patients with colorectal cancer affects their odds of response to and toxicity from regimens containing this agent

Adding Sequential Docetaxel to Adjuvant E→CMF Marginally Improves DFS in Early Breast Cancer Patients

October 01, 2006

Results of the multicenter Italian phase III Taxit 216 trial show marginally better disease-free survival (DFS) with the addition of sequential docetaxel (Taxotere) to standard epirubicin→CMF (cyclophosphamide/methotrexate/fluorouracil) as adjuvant treatment for high-risk early breast cancer, with acceptable toxicity.

Breast Ca Study Looking at Early Environmental Exposures

October 01, 2006

Investigators continue to seek participants in an unusual breast cancer epidemiologic study. Rather than recruit the traditional pool of adult women, the Environmental and Genetic Determinants of Puberty study hopes to accrue 1,200 girls age 6 to 8, to examine the relationships among breast development, age at first menses, and factors such as hormonal changes, diet, exercise, obesity, family medical history, psychosocial stressors, environmental exposures, and genetic characteristics and biomarkers.

Pre-IND Meeting for Lovaxin C

October 01, 2006

xAdvaxis, Inc. has conducted a pre-IND meeting with the FDA regarding its two planned phase II studies for its lead product Lovaxin C, a live Listeria vaccine for the treatment of cervical and head and neck cancers. The IND will be filed once phase I/II studies have been completed. In a separate news release, Advaxis announced that its breast cancer vaccine Lovaxin B, Listeria monocytogenes modified to deliver HER2/neu to immune cells, is in preclinical testing.

ODAC Recommends That FDA Approve New Indication for Fragmin to Reduce VTE Recurrences in Ca Patients

October 01, 2006

Members of the Oncologic Drugs Advisory Committee (ODAC) unanimously recommended that the Food and Drug Administration grant accelerated approval to Fragmin (dalteparin sodium, Pfizer) for the extended treatment of symptomatic venous thromboembolism (VTE), proximal deep vein thrombosis (DVT), and/or pulmonary embolism (PE) to reduce the recurrence of VTE in patients with cancer.