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Clinical Trials Monthly - March 2012

Clinical Trials Monthly presents new and important trials that may benefit your patients. This month we have included trials lymphoma, multiple myeloma, myelosdysplastic syndrome, polycythemia vera, and lung cancer. 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

Lymphoma

  • CAL-101 for Indolent B-Cell Non-Hodgkin’s Lymphoma (NCT01282424)
  • Lenalidomide -- Novel Chemotherapy-Free Approach for the Treatment of Follicular Lymphoma (NCT01476787)

Multiple Myeloma

  • Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma (NCT01335399)

Myelodysplastic Syndrome

  • ON 01910.Na for Refractory Myelodysplastic Syndrome (NCT01241500)

Polycythemia Vera

  • INC424 for Polycythemia Vera (NCT01243944)

Lung Cancer

  • BMS-936558 + Combination Chemotherapy for Non-Small Cell Lung Cancer (NCT01454102 )
  • Onartuzumab (MetMAb) for Squamous Non-Small Cell Lung Cancer (NCT01519804)
  • Onartuzumab (MetMAb) + Chemotherapy for Non-Squamous Non-Small Cell Lung Cancer (NCT01496742)

Lymphoma

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)

The purpose/goal of this study is to evaluate the therapeutic potential of a novel chemotherapy-free approach for the treatment of follicular lymphoma. This study will determine if lenalidomide (Revlimid), when given along with rituximab, can help control disease and increase the length of response (complete or partial) and progression-free survival compared to the standard care—rituximab plus chemotherapy treatment. Lenalidomide is an oralimmunomodulatory agent. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. It is currently used to treat myelodysplastic syndrome and multiple myeloma. This study is open to patients with histologically confirmed follicular lymphoma grade 1, 2 or 3a, stage II, III, or IV, who have not received prior systemic treatment for lymphoma.

Investigator: Edward N. Libby, MD

Multiple Myeloma

Phase III, Randomized, Open-Label Trial of Lenalidomide/
Dexamethasone with or without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma (NCT01335399)

Elotuzumab is a humanized monoclonal immunoglobin G1 antibody that targets CS1, a glycoprotein heavily expressed on the surface of multiple myeloma cells but with limited expression on normal cells. The purpose of this study is to determine whether the addition of elotuzumab to lenalidomide (Revlimid)/low-dose dexamethasone will increase the progression-free survival in those with newly diagnosed disease. Interim results of a Phase II trial presented at ASH 2010 (American Society of Hematology) indicated a response rate of 81 percent when elotuzumab was administered with lenalidomide and dexamethasone to patients with untreated multiple myeloma. Enrolled patients must have measurable disease, no previous anti-myeloma treatment, and not be a candidate for stem cell transplantation.

Investigator: William I. Bensinger, MD

Myelodysplastic Syndrome

Phase III Multicenter Randomized Controlled Study to Assess Efficacy and Safety of ON 01910.Na 72-Hr Continuous IV Infusion in MDS Patients with Excess Blasts Relapsing After or Refractory to or Intolerant to Azacitidine or Decitabine (NCT01241500)

The objective of this study is to compare overall survival in myelodysplastic syndrome (MDS) patients receiving Estybon (ON 01910.Na) plus best supportive care to survival in patients receiving best supportive care. ON 01910.Na is an investigational drug that inhibits cell growth and selectively kills cancer cells,

Patients in this study will have excess blasts (five to 30 percent bone marrow blasts) and have failed azacitidine or decitabine treatment. These patients have a short life expectancy (approximately four months). The high level of bone marrow activity of ON 01910.Na, documented in Phase I and II studies, has the potential to delay the transition of MDS to acute myeloid leukemia (AML), a significant and severe complication that shortens survival of these MDS patients.

Investigator: Bart Lee Scott, MD

Polycythemia Vera

Randomized, Open-Label, Multicenter Phase III Study of Efficacy
and Safety in Polycythemia Vera Subjects who are Resistant
to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets
versus Best Available Care (NCT012434944)

This pivotal Phase III trial (CINC424B2301) is designed to compare the efficacy and safety of INC424 (ruxolitinib) to the best available therapy in patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU). If study results are positive, INC424 would be the first FDA-approved treatment for this disease. Preclinical studies suggested that Janus kinase 1 and 2 (JAK1 and JAK2) need to work cooperatively to promote downstream signals that maintain normal hematopoiesis. Dysregulated JAK signaling has been associated with PV and two other myeloproliferative neoplasms.

Investigator: Bart Lee Scott, MD

Lung Cancer

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination with Gemcitabine + Cisplatin or Carboplatin as First-line Treatment for Patients with Stage IIIb or IV Squamous Non-Small Cell Lung Cancer (NCT01519804)

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable stage IIIB or stage IV squamous non-small cell lung cancer. Onartuzumab is a humanized monovalent monoclonal antibody directed against the hepatocyte growth factor receptor (c-Met). A variety of cancer cells overexpress cMET; onartuzumab, by inhibiting the c-MET signaling pathway, may have antineoplastic activity.

Patients will be randomized to receive either onartuzumab 15 mg/kg IV or placebo on day one of each of four 21-day cycles in combination with paclitaxel 200 mg/m2 IV and platinum (carboplatin/cisplatin) standard dose IV on the same day. Patients who have not progressed after four cycles will continue with either onartuzumab or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.

Investigator: Keith Eaton, MD, PhD

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of RO5490258 (MetMAb) Vs. Placebo in Combination with Either Bevacizumab + Platinum + Paclitaxel or Pemetrexed + Platinum in Patients with Untreated Stage IIIb or IV Non-Squamous Non-Small Cell Lung Cancer (NCT01496742)

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb or RO5490258), a humanized monovalent monoclonal antibody directed against the hepatocyte growth factor receptor (c-Met), in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable stage IIIB or IV nonsquamous non-small cell lung cancer.

In cohort one, patients will be randomized to receive four cycles of bevacizumab (Avastin) 15 mg/kg IV, paclitaxel 200 mg/m2 IV, platinum (cisplatin/carboplatin) standard dose IV plus either MetMAb 15 mg/kg IV or placebo on day one of each 21-day cycle. In cohort two, patients will be randomized to receive pemetrexed 500 mg/m2 IV, platinum (cisplatin/carboplatin) standard dose IV plus either MetMAb 15 mg/m2 IV or placebo on day one of each 21-day cycle.

Patients who have not progressed after four cycles will be offered maintenance therapy with their assigned treatment. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Investigator: Keith Eaton, MD, PhD

Multi-Arm Study of BMS-936558 in Combination with Three Platinum-Based Doublet Chemotherapy Regimens in Subjects with Treatment-Naive Stage IIIB/IV Non-Small Cell Lung Cancer (NCT01454102)

The study is evaluating the safety and tolerability of BMS-936558 (formerly MDX-1106) when combined with one of three platinumbased doublet chemotherapy regimens (cisplatin/gemcitabine; cisplatin/pemetrexed; or carboplatin/paclitaxel) in patients with non-small cell lung cancer. BMS-936558 is a fully human antibody against a protein (PD-1, Programmed Death-1) involved in repressing the immune system.

Blocking this protein with an antibody activates the immune system and enables it to fight tumors. In the same class of drugs as Yervoy, which blocks CTLA-4 (another immune-inhibitory protein), BMS-936558 was developed to allow the patient’s T cells to function with an anti-cancer response. Eligible patients are newly diagnosed with a confirmed stage IIIB/IV non-small cell lung cancer.

Investigator: Laura Q.M. Chow, 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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