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Clinical Trials Monthly - March 2011

Dear Colleague,

Most likely you've heard that clinical trials can offer your patients cutting-edge treatment. This month we highlight several studies for patients with:

Multicentric Castleman's disease (MCD) is a disorder characterized by abnormal non-cancerous growths in the lymphatic tissues. Patients with this rare and debilitating condition have very few therapeutic options. Recently, SCCA's Dr. Corey Casper and colleagues published the first data from the United States on a monoclonal antibody against interleukin-6, siltuximab. The Phase I study of 32 patients with Castleman's disease found that 78 percent of the 23 patients treated achieved a response, and no significant toxicities were noted. Now Dr. Casper is leading a Phase II registration study of siltuximab, which may present a unique opportunity for your patients with MCD. It also serves as a reminder of the potential of clinical trials for patients whose needs outstrip current treatment options.

Bone Marrow Transplant

A Phase II Study to Assess Immunosuppression with Sirolimus Combined with Cyclosporine (CSP) and Mycophenolate mofetil (MMF) for Prevention of Acute GVHD after Non-myeloablative HLA Class I or II Mismatched Donor Hematopoietic Cell Transplantation (FHCRC 2206)
This Phase II trial focuses on how well giving sirolimus together with cyclosporine and mycophenolate mofetil works in preventing graft-versus-host disease in patients with hematologic malignancies who are undergoing donor peripheral blood stem cell transplant.

Investigator: Brenda Sandemaier, MD
Conditions: hematologic malignancies

A Phase I/II Study Evaluating the Safety and Efficacy of Adding a Single Prophylactic Donor Lymphocyte Infusion (DLI) of Natural Killer Cells Early After Nonmyeloablative, HLA-Haploidentical Hematopoietic Cell Transplantation (FHCRC 2230)
The purpose of this study is to determine whether the experimental addition of cells after a non-myeloablative bone marrow transplant is safe for patients with life-threatening hematologic malignancies. The study also aims to determine the effects of this experimental treatment on recovery from transplant. The study is for patients who do not have a matched bone-marrow donor, and use a HLA-haploidentical donor.

Investigator: Brenda Sandmaier, MD
Conditions: chronic myeloproliferative disorders, leukemia, lymphoma, multiple myeloma and plasma cell neoplasm, myelodysplastic syndromes, myelodysplastic/myeloproliferative diseases.

Advanced Breast Cancer

Phase I Study of ABT-888 in Combination with Cisplatin and Vinorelbine for Patients with Advanced Triple Negative Breast Cancer and/or BRCA-Mutation Associated Breast Cancer (NCT01104259)
This Phase I trial is studying the side effects and best dose of ABT-888 when given together with cisplatin and vinorelbine ditartrate in treating patients with recurrent and/or metastatic breast cancer. ABT-888 may stop the growth of some tumor cells by blocking some of the enzymes needed for cell growth. Giving ABT-888 together with combination chemotherapy may kill more tumor cells.

Investigator: Eve Rodler, MD
Condition: advanced breast cancer

Prostate Cancer

A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naive Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy
The purpose of this study is to determine the benefit of MDV3100 versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but who have not yet received chemotherapy.

Investigator: Celestia Higano, MD
Condition: prostate cancer

Solid Tumor Cancer

A Randomized Discontinuation Study of XL184 in Subjects with Advanced Solid Tumors
The study aims to determine whether XL184 demonstrates anti-tumor activity in selected tumor types under a randomized discontinuation trial design. Patients who respond to XL 184 after 12 weeks of open-label administration will continue on the drug. Patients who are progressing will discontinue study treatment. Patients who demonstrate stable disease will be randomized to either XL184 or placebo. If disease progression is observed in individuals, patients randomized to placebo will be offered the option to receive open-label XL184. Patients who progressed while taking XL184 will discontinue study treatment.

Investigator: Celestia Higano, MD
Conditions: solid tumors cancers

Tumors with ALK Mutation

A Dose Finding Study with Oral LDK378 in Patients with Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK) (NCT01283516)
This Phase I study will assess the safety and early efficacy of LDK378 in patients with genetic abnormalities in anaplastic lymphoma kinase (ALK). Tumor must be confirmed to be ALK positive.

Investigator: Laura Q.M. Chow, MD
Conditions: tumors characterized by genetic abnormalities of ALK

Multicentric Castleman's Disease

A Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti IL 6 Monoclonal Antibody) plus Best Supportive Care Compared with Best Supportive Care in Subjects with Multicentric Castleman's Disease (FHCRC 2366)
SCCA is participating in a pivotal Phase II registration study of siltuximab for patients with multicentric Castleman's disease. The study may present a unique opportunity for patients with this rare, debilitating condition. Patients will have the opportunity to receive siltuximab. Those randomized to placebo will be crossed-over to the active drug for persistent signs and symptoms of MCD on best supportive care.

Investigator: Corey Casper, MD, MPH
Condition: Multicentric Castleman's disease

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


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Clinical Trials Monthly

Each issue of Clinical Trials Monthly highlights several of the more than 200 clinical trials that are currently recruiting patients at SCCA.

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Each quarterly Leading Edge newsletter will highlight a new topic to give you the latest news on leading-edge therapies that SCCA physicians are offering.