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Clinical Trials Monthly - April 2011

Dear Colleague,

This month we’re focused on melanoma, recurrent/metastatic breast cancer, lung cancer and lymphoma. You are encouraged to review these and all of the trials on our easy-to-use database: www.seattlecca.org/clinical-trials.

Highlighted trials this month include:


Melanoma

Last month, the Federal Drug Administration (FDA) approved ipilimumab (Yervoy), the first drug shown to prolong the lives of people with melanoma.

“This is an altogether new approach to immunotherapy,” says Dr. Kim Margolin, professor of medical oncology at the University of Washington and director of the study of Yervoy at SCCA. “It blocks the signals that T lymphocytes use to control normal reactions. The result is that T lymphocytes and the cells that assist them in recognizing and eradicating tumor cells are re-activated.”

To see all of the melanoma trials being conducted at SCCA
go to www.seattlecca.org/clinical-trials/melanoma-list.cfm.

GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain
GSK2118436 is a new drug that’s being developed by GlaxoSmithKline that may help melanoma patients whose cancer has metastasized to the brain. GSK2118436 inhibits the activity of B-raf, a protein that’s been associated with several types of cancer including melanoma. This is a Phase II open-label, two-cohort, multi-center study designed to assess the efficacy, pharmacokinetics, safety and tolerability of an oral, twice-daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or V600K mutation-positive metastatic melanoma to the brain.

Investigator: Kim Margolin, MD


Breast Cancer

Zoledronic Acid for Bone Metastases from Breast Cancer (6979)
Zoledronic acid (Zometa) is an approved treatment for patients with bone metastasis and complications from multiple myeloma. This Phase III study looks at how effective zoledronic acid is in treating breast cancer patients with bone metastasis. The trial compares the effectiveness of giving zoledronic acid every four weeks versus every 12 weeks over the course of one year.

Patients are expected to be in this study for about one year. There will be a total of 15 scheduled patient visits to complete this study: a screening visit; 13 treatment visits once a month (treatment is IV over one hour, usually) and one end-of-study visit. Patient diary information will be collected by a touch-tone telephone system (IVRS) one time a week.

There is an optional pharmacokinetic sub-study involving additional urine specimen collection. Treatment will be done at SCCA. Network locations are not involved.

Investigator: Georgiana Ellis, MD

Lapatinib vs Trastuzumab + Taxane for HER2/Positive First-line Metastatic Cancer (UW09024)
Drugs used in chemotherapy, such as paclitaxel (Taxol) and docetaxel (Taxotere), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab (Herceptin), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether chemotherapy is more effective with lapatinib or trastuzumab in treating breast cancer patients. This randomized Phase III trial is studying chemotherapy and lapatinib to see how well they work compared with chemotherapy and trastuzumab in treating women with HER2/neu-positive metastatic breast cancer.

Investigator: Georgiana Ellis, MD

Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice (6916)
This research study examines the effectiveness of a newly developed computer system. The system is designed to help patients report and manage symptoms related to chemotherapy and/or endocrine therapy. The system also notify care providers of symptoms. This allows providers to address symptoms in a timely fashion. This study examines whether the reporting and the notification features improve patient-provider communication and assist physicians in making clinical decisions.

Investigator: VK Gadi, MD, PhD

Expanded Access Protocol of Iniparib in Combination with Gemcitabine/Carboplatin (20100374) (10009)
Expanded access is for patients, who would benefit from a life-saving drug, that otherwise do not meet full eligibility criteria of that drug in the clinical trial. This trial is designed to offer pre-approval drug access to iniparib (a PARP inhibitor) in combination with gemcitabine and carboplatin in order to provide potential clinical benefit to patients with ER-, PR-, and HER2-negative metastatic breast cancer.

Investigator: Jennifer Specht, MD

Triple Negative Gen (6628)
Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab (Avastin), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread, while others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib (Tarceva) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized nanoparticle formulation together with bevacizumab and erlotinib may kill more tumor cells.

This Phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab work when followed by bevacizumab and erlotinib in treating patients with metastatic breast cancer.

Investigator: Jennifer Specht, MD

Pfizer Sutent (6488)
This is a Phase II study evaluating the safety and efficacy of sunitinib maleate in combination with weekly paclitaxel followed by doxorubicin and daily oral cyclophosphamide plus G-CSF as neoadjuvant chemotherapy for locally advanced or inflammatory breast cancer.

The purpose of this study is to determine the safety and effectiveness of an investigational drug treatment for patients with locally advanced or inflammatory breast cancer. In this research study, an investigational drug called sunitinib (Sutent) will be added to the current, standard (non-research) drug treatment for locally advanced or inflammatory breast cancer.

Participants will receive treatment at Seattle Cancer Care Alliance. If hospitalization is needed while in Seattle, participants will be admitted to University of Washington Medical Center. Treatment on this study will last about six months. Surgery, which is not a part of this study treatment, is expected to take place about a month after completion of this study treatment. Follow-up may continue for up to five years after treatment has stopped.

Investigator: Jennifer Specht, MD


Lung Cancer

NCT00932451 Crizotinib (PF-02341066) for NSCLC with Profile Involving ALK Gene (UW09035)
Crizotinib is an anaplastic lymphoma kinase (ALK) inhibitor that has shown early promise for patients with advanced lung cancer. This Phase II trial evaluates the safety and efficacy of crizotinib in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. Patients who participated in Study A8081007 (see NCT00932893) are also eligible for this trial.

Patients must be ALK-positive. Treatment includes taking oral pills twice daily at home. Patients will visit SCCA labs and their physician every three weeks. They will have CT scans at SCCA every six weeks. Crizotinib is provided by Pfizer, all other standard of care procedures (labs, MD visit, etc.) are billed to insurance. Screening procedures included are EKG, brain MRI, bone scan, CT scans, labs, and physical exam, etc.

Investigator: Renato Martins, MD, MPH

NCT00676507 Lucanix Vaccine Therapy for NSCLC (UW08006)
Lucanix is a vaccine therapy that has shown early promise for patients with advanced lung cancer. Vaccines made from gene-modified tumor cells such as Lucanix may help the body build an immune response to kill tumor cells. This is Phase III trial is studying Lucanix to see how well it works compared to a placebo in treating subjects with Stage III or stage IV nonsmall cell lung cancer. Patients must have had a response or be stable following first-line chemotherapy. Lucanix injection, labs and physician visits will take place every month at SCCA only. Patients will receive CT scans (at SCCA only) every three months. Lucanix is provided by NovaRx; all other standard of care procedures (labs, MD visit, etc.) are billed to insurance. Screening procedures included are EKG, brain MRI, bone scan, CT scans, labs and physical exams, etc.

Investigator: Keith Eaton, MD, PhD


Lymphoma

TREC for Relapsed or Refractory Lymphoid Malignancies (PSOC 2502)
This Phase I trial is studying the side effects and best dose of bendamustine hydrochloride when given together with carboplatin, etoposide, and rituximab in treating patients with relapsed or refractory lymphoid malignancies.

Drugs used in chemotherapy, such as bendamustine hydrochloride (Treanda), etoposide (Eposin), and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab (Rituxan), can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread, while others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bendamustine hydrochloride together with carboplatin, etoposide, and rituximab may kill more cancer cells.

Investigator: Lihua Elizabeth Budde, MD, PhD


Referral or Consultation

To discuss treatment options for your patients with a physician, please call our intake office at (206) 288-SCCA (7222) or (800) 804-8824. To read the full description of each trial and or enroll your patients online, please see www.seattlecca.org/clinical-trials.


 


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