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Clinical Trials Monthly - September 2011

Dear Colleague,

This month we’ve described several ongoing Phase I, II, and III trials for squamous cell carcinoma of the head and neck, lung cancer, non-squamous carcinoma of the lung, renal cell carcinoma, and brain metastasis from breast cancer.

Each study summary has a link to the specific details about that trial in our online Clinical Trials Database. The complete list of trials recruiting participants at Seattle Cancer Care Alliance can be found at


Head and Neck Cancer

Lung Cancer

Renal Cell Carcinoma

Breast Cancer

FDA approves Adcetris to treat two types of lymphoma

The U.S. Food and Drug Administration approved Adcetris (brentuximab vedotin) to treat Hodgkin’s lymphoma (HL) and a rare lymphoma called systemic anaplastic large cell lymphoma (SAL).

Adcetris is an antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30. It is used to treat HL that has progressed after autologous stem cell transplant or after two prior chemotherapy treatments for those who cannot receive a transplant. Adcetris may also be used for SAL that has progressed after one prior chemotherapy treatment.

“ Early clinical data suggest that patients who received Adcetris for Hodgkin lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy,” said Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

Adcetris is the first new FDA-approved treatment for Hodgkin’s lymphoma since 1977 and the first specifically indicated to treat anaplastic large cell lymphoma.

The drug is being approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The program is designed to provide patients with earlier access to promising new drugs, but the company will be required to submit additional clinical information after approval to confirm the drug’s clinical benefit.


Head and Neck Cancer

Phase I Clinical Trial of VTX-2337, a Small Molecule Toll-Like Receptor 8 Agonist in Combination with Cetuximab (Erbitux) in Patients with Recurrent or Metastatic Squamous Cell Carcinomas of the Head and Neck. (NCT01334177)

This Phase I trial studies the side effects and best dose of TLR8 Agonist VTX-2337 (VTX-2337) when given together with cetuximab (Erbitux) in treating patients with locally advanced, recurrent, or metastatic squamous cell cancer of the head and neck. Biological therapies, such as VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies such as cetuximab 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. Giving VTX-2337 together with cetuximab may kill more tumor cells.

Patients will first receive one cycle of cetuximab. One cycle is four doses; one dose once a week intravenously. Treatment then begins with cetuximab and VTX-2337. During the treatment phase, the patient will have blood draws to measure immune function, certain genes, and proteins before, and in some cases, after each treatment dose. VTX-2337 is given as an injection underneath the skin in the arm and will be given once a week after the Cetuximab infusion. It will be given three out of every four weeks. After treatment is complete, patients will enter the follow-up part of the study. This study will take about 4 months to complete.

Investigator: Laura Q.M. Chow, MD


Lung Cancer

A Randomized, Double-Blind, Phase II Study of Erlotinib (Tarceva) in Combination with OSI-906 or Placebo in Chemo-naive Patients with Advanced Non-small Cell Lung Cancer with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

Tarceva® (erlotinib) is a drug that blocks a receptor called the Epidermal Growth Factor Receptor (EGFR). OSI-906 is an experimental drug that blocks two receptors: the Insulin-like Growth Factor-1 Receptor (IGF-1R) and the Insulin Receptor (IR). EGFR, IGF-1R, and IR are found on the surface of many tumor cells and are involved in cancer growth, development, and survival. These receptors may be overactive in some cancers like non-small cell lung cancer (NSCLC).

Erlotinib is approved by the U.S. Food and Drug Administration for the treatment of advanced NSCLC in patients after at least one chemotherapy treatment. Some studies have shown that NSCLC subjects with some EGFR gene mutations may do better on EGFR inhibitors, such as erlotinib, than on chemotherapy. However, erlotinib has not been approved in subjects with an EGFR gene mutation who have not yet received chemotherapy. Thus, for the purpose of this study, erlotinib is still an experimental drug, which means that government regulatory agencies have not approved it for this use.

Patients will come to SCCA once every three weeks (21-day cycle) as long as they are receiving OSI-906/placebo or erlotinib. Cycle 1, 2 and 3 visits may last up to six hours and subsequent cycle visits may last up to two hours. OSI-906/placebo is taken by mouth twice daily, at approximately the same time each day. Erlotinib is taken once daily, at approximately the same time each morning.

OSI-906 is a new experimental drug that is in the early stages of development. It has been given to over 300 subjects with cancer. In this study, OSI-906 or placebo will be given with erlotinib to subjects with NSCLC who have not yet received chemotherapy. OSI-906 and erlotinib have been tested together in a small number of subjects. It is unknown if these two drugs will be safe and/or effective in the treatment of NSCLC patients who have an EGFR gene mutation and have not yet received chemotherapy.

Investigator: Keith Eaton, MD, PhD

Phase III, Randomized, Open-Label Study of the Efficacy and Safety of Crizotinib Versus Pemetrexed(Alimta)/Cisplatin or Pemetrexed/Carboplatin in Previously Untreated Patients with Non-Squamous Carcinoma of the Lung Harboring a Translocation or Inversion Event Involving the Anaplastic Lymphoma Kinase (ALK) Gene Locus (NCT01154140)

This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

After screening, if patients are eligible and agree to participate in this study, treatment will be assigned by chance, either crizotinib (called treatment A) or chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin, called treatment B). If assigned treatment B, the patient and study doctor will decide which chemotherapy the patient will receive.

Following evaluations, physical exam, and blood tests (within seven days of the first dose of study treatment (which is defined as Cycle 1 Day 1) patient will receive the first dose of study treatment. Study procedures are based on a cycle of the treatment. All cycles will be 21 days (three weeks). Additional tests may be necessary.

Investigator: Keith Eaton, MD, PhD

A Randomized Double-blind Phase III Efficacy and Safety Study of PF-00299804 Versus Erlotinib (Tarceva) for the Treatment of Advanced Non-small Cell Lung Cancer Following Progression After, or Intolerance to, at Least One Prior Chemotherapy. (UW1108; NCT01360554)

This is a multinational, multicenter study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

Patients will receive either PF-00299804 or erlotinib (Tarceva®); with a 50 percent chance of being assigned either treatment. Every cycle (approximately 28 days) patients will be evaluated through blood tests, CT scans, vital signs, etc. After the Post-Treatment Follow-Up Visit, patients will be asked to return to the study site or will be contacted by the site staff by phone about every two months to discuss your health status and other additional treatment information.

Investigator: Renato Martins, MD, MPH


Renal Cell Carcinoma

A Phase III Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects with Localized or Locally Advanced RCC following Nephrectomy – The PROTECT Trial (NCT01235962)

Pazopanib is an oral tyrosine kinase inhibitor, FDA-approved, for treatment of advanced renal cell carcinoma. This study will evaluate whether one year of pazopanib therapy has activity in the adjuvant setting to extend disease-free survival. The study is placebo controlled with a 50:50 randomization.

Patients will consent no sooner than four weeks after nephrectomy. Screening procedures must be completed no later than 10 weeks after nephrectomy. (Screening procedures are lab tests, scans, physical exam, etc.) Eligible patients are randomized to receive either pazopanib or placebo. The patient will take the study drug (pazopanib or placebo) daily for up to one year. The patient will come to the study center for several visits (more frequently at the beginning) to ensure that the drug is not causing undue harm and to check if it is working. After completing one year of treatment, the patient will come back to the study site every six months for five years for follow-up, and once a year after that.

Investigator: Scott S. Tykodi, MD, PhD

A Randomized, Controlled Phase III Study Investigating IMA901 Multipeptide Cancer Vaccine in Patients Receiving Sunitinib (Sutent) as First-line Therapy for Advanced/ Metastatic Renal Cell Carcinoma (NCT01265901)

IMA901 is a novel, multi-peptide cancer vaccine specific for HLA-A2-positive renal cell carcinoma patients. This study will evaluate whether the addition of a cancer vaccine to standard therapy with sunitinib will lead to extended overall survival. Patients must have metastatic clear cell RCC and are randomized to treatment with the investigational vaccine plus sunitinib versus sunitinib alone in a 3:2 ratio.

Patients can expect to be tested to see if they are HLA-A2-positive. Patients who are HLA-A2-positive will complete screening (including lab tests, scans physical exams, etc.) Eligible patients will begin taking Sutent daily for four weeks, followed by two weeks off, to make up a six-week cycle. About four weeks after starting Sutent, patients will be randomized to either Sutent alone or Sutent plus the investigational vaccine, IMA-901. All patients will continue on the six-week cycles with regular visits to the study site for lab tests and scans. Patients randomized to Sutent plus IM-901 will also receive a single dose of GM-CSF followed by a course of 11 vaccinations over a four-month period. (Vaccinations are more frequent at the beginning of the four-month period.) All patients will continue receiving study treatment until the drug stops working or the side effects are too great. Patients will come to the study site every 12 weeks for up to 19 months after stopping treatment for follow-up. Patients will be contacted every three months for up to eight years to check on their survival status.

Investigator: Scott S. Tykodi, MD, PhD


Breast Cancer

Phase II Study of the Combination of High-Dose Methotrexate and Intrathecal Liposomal Cytarabine in Patients with Leptomeningeal Metastases from Breast Cancer with or without Parenchymal Brain Involvement (UWCC-6954; NCT00992602)

The study is seeking patients whose breast cancer has metastasized to the brain. Drugs used in chemotherapy, such as methotrexate and liposomal cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-dose systemic methotrexate with intra-CSF liposomal cytarabine may kill more tumor cells. This trial is studying how well giving high-dose methotrexate together with liposomal cytarabine works in treating patients with CNS metastases from metastatic breast cancer. Two kinds of chemo will be given alternating every other week. Methotreaxate infusion will be given as an in-patient. Patients need to be hospitalized two to three days to receive treatment. Depocyt will be given as an outpatient via a shunt placed in the patient’s head. Patients will continue to receive treatments until they fail or progress. The cost of Depocyt (investigational for this patient population) will be covered by the sponsor. Patients are responsible for any other cost encountered in this study.

Investigator: Maciej Mrugala, MD, PhD, MPH


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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