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Clinical Trials Monthly - June 2012




Clinical Trials Monthly presents new and important trials that may benefit your patients. This month we’ve included trials for breast cancer, colon cancer screening, salivary gland tumors, and lymphoma.

Each study summary has a link to the specific details about the trial on our online Clinical Trials Database. The complete list of all trials recruiting participants at Seattle Cancer Care Alliance can be found at www.seattlecca.org/clinicaltrials.

THIS MONTH’S FEATURED CLINICAL STUDIES

Breast Cancer
  • Denosumab as Adjuvant Treatment for Early-Stage Breast Cancer at High Risk of Recurrence (NCT01077154)
Colon Cancer
  • Biomarkers for Early Detection of Colorectal Adenocarcinoma in Adults Undergoing Colonoscopy (NCT01511653)
Salivary Gland Cancer
  • Eribulin for Locally Advanced Salivary Gland Cancers (NCT01613768)
Lymphoma
  • CAL-101 for Indolent B-Cell Non-Hodgkin’s Lymphoma (NCT01282424)
  • CAL-101 for Relapsed or Refractory Hodgkin’s Lymphoma (NCT01393106)
  • Rituximab + Lenalidomide vs Chemotherapy (RELEVANCE-7636) for Follicular Lymphoma (NCT01476787)

Breast Cancer

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence (UW11015) (NCT01077154)

This randomized Phase III trial will determine if denosumab can prevent disease recurrence in the bone or in any other part of the body when it is given as adjuvant therapy for women with early-stage breast cancer who are at high risk of disease recurrence. Bone is a frequent site of relapse for women with early-stage breast cancer. Most women with advanced breast cancer will one day develop disease in the bone.

Denosumab is a fully human monoclonal antibody that specifically inhibits RANK ligand and thereby blocks maturation of osteoclasts, which break down bone as part of the natural bone recycling process. The antibody is currently approved to treat postmenopausal osteoporosis and to prevent bone problems related to cancer metastases. The hypothesis in the breast cancer study is that denosumab may interrupt a “vicious cycle” of cancer-induced bone destruction and tumor cell expansion through the bone. It is not yet known if denosumab may prevent disease recurrence in the bone or in any other part of the body.

Women enrolled will receive subcutaneous injections of either the active agent or placebo, monthly for 6 months and then every 3 months for 4½ years. All study participants take daily calcium and vitamin D supplements. Nationwide, 4500 women will enroll in the study.

Colon Cancer

Study of Biomarkers for Early Detection of Colorectal Adenocarcinoma in Adults Undergoing Colonoscopy (NCT01511653)

Dr. William M. Grady’s lab is helping in the attempt to validate noninvasive molecular markers of colon cancer that may eventually replace the need for widespread colonoscopy screening. The study is part of a national multicenter study that seeks to enroll 6000 subjects who are asymptomatic, 50 to 80 years of age, and having routine colon screening. The researchers will compare the screening results from two stool-based biomarkers (one is a panel) and one serum-based biomarker with results from colonoscopy and FIT (fecal immunohistochemistry) tests, which are the current standards for colon cancer screening.

This is funded by the National Cancer Institute’s Early Detection Research Network. The population targeted for this study is persons undergoing colonoscopy for screening or routine surveillance. Prior to prepping for colonoscopy, subjects will provide blood and stool samples as well as specific data regarding their GI and general medical history and concomitant medications. The goal of the study is to find accurate noninvasive tests that will allow more focused use of colonoscopy in those deemed to be high risk for colorectal cancer.
 

Investigator: William M. Grady, MD

 

Salivary Gland Cancer

Phase II Trial of Eribulin for Locally Advanced Refractory or Metastatic Salivary Gland Cancers (NCT01613768)

Researchers at SCCA have partnered with the National Cancer Institute to initiate a study examining the safety and efficacy of eribulin (eribulin mesylate) in patients with salivary gland cancer. Approved about two years ago for use in advanced breast cancer, eribulin is a microtubule inhibitor that blocks cell division and leads to cell death (apoptosis). SCCA researchers hope that this unique drug will provide a new treatment alternative for patients whose salivary gland cancer is too far advanced for surgery or radiation.

This is a relatively rare and little-studied disease and pharmaceutical companies have historically not been interested in developing drugs for these patients. UW Medical Center is one of only three centers in the U.S. with a neutron beam radiation facility—now considered the best therapy for early salivary gland cancer. This capability has attracted patients from all over the country to Seattle for care and that is why clinicians here have long been interested in developing new therapies for this population.

The new open-label study with eribulin involves two IV injections every 21 days and the treatment will continue until disease progression or toxicity. SCCA is the only site in the U.S. currently enrolling patients in this Phase II study.
 

Investigator: Keith D. Eaton, MD, PhD

 

Lymphoma

A Phase II Study to Assess the Efficacy and Safety of CAL 101 in Patients with Relapsed or Refractory Hodgkin’s Lymphoma (NCT01393106)

CAL-101 (GS-1101) is a potent, selective inhibitor of a type of phosphatidylinositol 3 kinase (PI3K) enzyme that is implicated in cancer and inflammatory diseases. In the Phase I trial of this drug, CAL-101 was well tolerated with no dose-limiting toxicity in any of the patients. CAL-101 decreases cellular proliferation and/or cell death in a range of non-Hodgkin’s lymphoma (NHL) cell lines. In this open-label, single-arm, Phase II study, patients with histologically confirmed classic Hodgkin’s lymphoma will receive CAL-101 in tablet form to be taken twice per day, once in the morning and once in the evening, starting at 150 mg twice per day.

Treatment with CAL-101 can continue in responding patients as long as the study is still ongoing and the patients have no excess toxicity from treatment. The primary outcome is overall response rate.
 

Investigator: Ajay K. Gopal, MD


A Phase II Study to Assess the Efficacy and Safety of CAL-101 in Patients with Indolent B-Cell Non-Hodgkin’s Lymphoma Refractory to Rituximab and Alkylating Agents (NCT01282424)

The purpose of this study is to evaluate the efficacy and safety of CAL-101 (GS-1101) in patients with previously treated, indolent (slow-growing) non-Hodgkin’s lymphoma (iNHL) that is resistant to rituximab and alkylating-agent chemotherapy.

The primary objective will be to assess the overall response rate. CAL-101 is a potent, selective inhibitor of a type of phosphatidylinositol 3 kinase (PI3K) enzyme that is implicated in cancer and inflammatory diseases.
In the Phase I trial of this drug, CAL-101 was well tolerated with no dose-limiting toxicity in any of the patients. CAL-101 decreases cellular proliferation and/or cell death in a range of non-Hodgkin’s lymphoma cell lines.

Eligible patients will be older than 18 years of age and have histologically confirmed B-cell iNHL. Treatment with CAL-101 can continue in responding patients as long as the study is ongoing and the patients have no excess toxicity from treatment.
 

Investigator: Ajay K. Gopal, MD


A Phase III Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects with Previously Untreated Follicular Lymphoma. The “RELEVANCE” Trial (Rituximab Lenalidomide Versus any Chemotherapy) (NCT01476787)

A new international, randomized study at SCCA, the RELEVANCE trial hopes to provide a better treatment for newly diagnosed follicular lymphoma patients. This trial will help determine whether a new combination of approved drugs, lenalidomide and rituximab, neither of which are chemotherapies, is more effective than the standard of care. “We are looking for high response rates and longer response rates,” says Edward N. Libby, MD, lead investigator on the RELEVANCE trial at SCCA.

Unique to this study is lenalidomide (Revlimid), which has been added in for maintenance – small doses over long periods of time. “Revlimid affects the immune system in ways to help kill cancer, but we don’t know exactly how this works,” Libby says. Revlimid is currently used to treat multiple myeloma and myelodysplasia.

Both of the study drugs have been approved for treatment in other diseases. Patients gaining control of their disease will have rituximab every three weeks and lenalidomide three out of four weeks until which time maintenance therapy can begin.
 

Investigator: Edward N. Libby, MD


 

Referral or Consultation

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


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