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Clinical Trials Monthly - August 2011

Dear Colleague,

This month we’ve included Phase I, II, and III trials for breast and prostate 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 that are recruiting participants at Seattle Cancer Care Alliance can be found at www.seattlecca.org/clinicaltrials.

THIS MONTH’S FEATURED CLINICAL STUDIES

Breast Cancer 

Prostate Cancer 

Breast Cancer

Ampligen w/Vaccine Therapy and Sargramostim for Stage II-IV HER2-Positive Breast Cancer (7425)
Phase I-II Study of HER2 Vaccination With Poly(I) • Poly(C12U)
Ampligen as an Adjuvant in Optimally Treated Breast Cancer Patients (NCT01355393)

This is a Phase I-II randomized two-stage HER-2 vaccine study in breast cancer patients.

In the first study stage, patients are randomized to one of four groups with each arm receiving the synthetic HER-2/neu peptide vaccine admixed with Ampligen (at four different doses) given intradermally (ID) to identify the most active dose. Patients in the second study stage are then randomized to one of two treatment arms. ARM I patients receive the synthetic HER-2/neu peptide vaccine admixed with GM-CSF given ID. ARM II patients receive the HER-2/neu peptide vaccine admixed with GM-CSF and Ampligen (at the dose set by stage I group that had the most active response) given ID. In both study stages, treatment repeats once a month for up to three months in the absence of disease progression or unacceptable toxicity.

Investigator: Lupe G. Salazar, MD

Prostate Cancer

Bicalutamide and Goserelin or Leuprolide Acetate w/wo Cixutumumab for Newly Diagnosed Metastatic Prostate Cancer (SWOG 0925)

A Randomized Phase II Study of Combined Androgen Deprivation Versus Combined Androgen Deprivation with IMC-A12 for Patients with New Hormone Sensitive Metastatic Prostate Cancer (NCT01120236)

Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, goserelin, or leuprolide acetate, lessen the amount of androgens made by the body. Monoclonal antibodies, such as cixutumumab (ICM-A12), 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. This antibody also prompts cells to ingest and break down IGF receptors, leaving fewer of them on the cell surface. Pre-clinical data shows that when cixutumumab is combined with ADT, more prostate cancer cells die and the time until the cancer becomes resistant to ADT is significantly lengthened. It is not yet known whether bicalutamide, goserelin, or leuprolide acetate is more effective when given with or without cixutumumab in treating prostate cancer.

This randomized Phase II trial is studying bicalutamide, goserelin, and leuprolide acetate to see how well they work when given with or without cixutumumab in treating patients with newly diagnosed metastatic prostate cancer.

Patients will be randomized to receive either standard combined ADT—seven four-week cycles of bicalutamide and an LHRH agonist—or standard combined ADT plus the antibody cixutumumab. At the end of 28 weeks, patients will have their blood tested for prostate specific antigen (PSA) level. Undetectable PSA, defined as a PSA ≤ 0.2 ng/mL, is the primary goal and the number of patients in each arm who meet this endpoint will be directly compared. Previous studies have shown that an undetectable PSA at this time point correlates with better long-term survival.

Investigator: Evan Y. Yu, MD

SCORE (30824)

SCORE — Assessment of Mood, Information Processing, and Quality of Life in Prostate Cancer Survivors and Patients

This study is designed to investigate cognition, mood, and quality of life changes in men about to start/restart androgen-deprivation therapy (ADT) under the care of their physician.

Despite improvements in surgical and radiation techniques, about 40 percent of men will relapse after primary prostate cancer treatment. While much is known about physiological changes, little is known about possible cognitive, mood, and quality of life changes from ADT. Men often experience symptoms of depression and anxiety, low energy, and cognitive deficits. Because cognitive deficits and mood symptoms are common among cancer survivors, it is unclear whether these changes are related to the loss of androgens residual effects from chemotherapy and/or radiation, or the stress and emotional effects of dealing with a life-threatening illness or an interaction of these factors.

After completing ADT, participants are randomized into one of two groups receiving either testosterone or placebo gel for up to one month — randomization is optional. Use of the “off-on-off” design allows for examination of intra-patient changes. This study compares the ADT treated patients to a range-matched prostate cancer control group (non-metastatic and post-primary therapy) for between-group comparisons.
This is an outpatient study at Seattle Cancer Care Alliance or Veterans Affairs Medical Center in Seattle. Participants will complete approximately six visits. Each visit will last about two to three hours and will include a blood draw.

Compensation: 1) Control group will receive up to $150 upon completion of the study. 2) Treatment group will receive up to $300 upon completion of the study. Checks will be sent by mail.

Investigator: Monique Cherrier, PhD

Cabozantinib (XL184) for Advanced Malignancies

A Randomized Discontinuation Study of XL184 in Subjects With Advanced Solid Tumors (NCT00940225)

The purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of a new compound, cabozantinib (XL184), as well as characterize the pharmacokinetic and pharmacodynamic activity, correlate the pathway dysfunction of disease-related genes or proteins, and identify surrogate biomarkers associated with clinical activity of XL184, a small molecule that inhibits multiple receptor tyrosine kinases (RTK’s).

The primary RTK targets are important driving forces in angiogenesis, implicated in the ability of tumors to overcome hypoxia following angiogenesis inhibition. XL184 combines anti- MET activity with inhibition of additional targets such as VEGFR, inhibiting growth and metastasis of tumor cells. Tumor shrinkages and decreased pain levels have been dramatic.

After screening, patients will answer pain/analgesia questionnaires for at least four of seven days before receiving the first dose of study drug on Week one Day one. Thereafter, the patient will return to SCCA every three weeks for study visits, with a bone scan and CT or MRI done every six weeks at SCCA. The study treatment period will last until progression or unacceptable toxicity occurs. Patients will be required to contact a centralized call center to report pain status and analgesia use prior to every six weeks for at least four out of seven consecutive days.

Investigator: Celestia Higano, MD 

New hormonal therapy in testing for late-stage prostate cancer

By Bruce Montgomery, MD
Radiation therapy combined with hormone suppression is a standard approach for treatment of intermediate and high risk prostate cancer, providing better survival outcomes compared to radiation or hormone suppression alone.[1] Data just published in the New England Journal of Medicine shows that androgen deprivation resulted in a better cure rate for men with intermediate stage and grade prostate cancer, yielding radiosensitization to radiation effects.

Abiraterone (Zytiga) is a new class of hormonal agent designed to more effectively suppress testosterone in the blood and cancer, lowering serum and tissue testosterone levels below those achieved with standard hormonal therapy. The drug works to directly inhibit the process of steroidogenesis by inhibiting the enzyme CYP17 in the adrenal gland and tumor tissue itself. The drug builds on work performed at the University of Washington and Fred Hutchinson Cancer Research Center that shows that prostate cancer can become resistant by producing its own hormones in response to hormone deprivation with standard LHRH antagonists.[2, 3]

Abiraterone improved survival in men with very advanced prostate cancer that was resistant to standard hormonal therapy and chemotherapy, demonstrating that hormone production by the cancer is a relevant mechanism of progression.[4] An ongoing study at SCCA and University of Washington is testing the effects of abiraterone with radiation therapy for men who are candidates for radiation with hormonal therapy. The primary aims of the study are to evaluate the safety of radiation with abiraterone, and to assess the effects of abiraterone on prostate cancer hormone levels.

Providing more effective hormonal therapy early in the course of treatment may improve both local and systemic control of the disease.

Phase II Trial of Radiation with Androgen Deprivation (RAD): Abiraterone Acetate, Prednisone and LHRH Agonist Prior to and Concurrent with Radiation Therapy. 7048. NCT01023061

Contact Robyn Haaf, RN at (206) 667-5974, Bruce Montgomery, MD, pager (206) 559-5058, or Ken Russell, MD (206) 288-7100 for more information.

1. Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C et al: Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet 2002, 360(9327):103-106.

2. Mostaghel EA, Page ST, Lin DW, Fazli L, Coleman IM, True LD, Knudsen B, Hess DL, Nelson CC, Matsumoto AM et al: Intraprostatic androgens and androgen-regulated gene expression persist after testosterone suppression: therapeutic implications for castration-resistant prostate cancer. Cancer Res 2007, 67(10):5033-5041.

3. Montgomery RB, Mostaghel EA, Vessella R, Hess DL, Kalhorn TF, Higano CS, True LD, Nelson PS: Maintenance of intratumoral androgens in metastatic prostate cancer: a mechanism for castration-resistant tumor growth. Cancer Res 2008, 68(11):4447-4454.

4. de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB, Jr., Saad F et al: Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011, 364(21):1995-2005.


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