April 2015, VOL 6, NO 2

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Clinical Trials Tracker

Clinical Trials Under Way in Prostate Cancer, Brain Cancer

The following clinical trials are currently recruiting patients with cancer for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with ClinicalTrials.gov.

PROSTATE CANCER

Radiation Therapy with or without Androgen Deprivation Therapy
This phase 3, parallel-assignment, open-label study ex- amines the effectiveness of radiation therapy when it is given with or without androgen deprivation therapy com- prising a luteinizing hormone-releasing hormone (LHRH). Patients aged ≥18 years with prostate cancer may enroll if other criteria are met. Patients are randomized to receive (1) external-beam radiation therapy once daily on days 1 to 5 or (2) an LHRH agonist subcutaneously or as an injection every 1 to 3 months with oral flutamide or bicalutamide for 6 months. Beginning 8 weeks after the first LHRH injection, patients will undergo radiotherapy as in the non-LHRH group.

The primary objective is overall survival (OS), measured from the date of randomization to the date of death due to any cause. Secondary outcome measures include biochemical failure, local or regional disease recurrence, and distant metastasis. This study is expected to enroll 1520 patients at sites throughout the United States. For more information, contact Alvaro Martinez, MD, FACR, at 248-553-0606 or alvaro. martinez@rtsx.com. The NLM Identifier is NCT00936390.

Safety and Efficacy of Enzalutamide
This phase 3, parallel-assignment, double-blind study assesses the safety and efficacy of enzalutamide in patients with nonmetastatic prostate cancer. Patients aged ≥18 years who have ongoing androgen deprivation therapy with a gonadotropin-releasing hormone agonist/antagonist or prior bilateral orchiectomy may enroll if other criteria are met. Patients are randomized to placebo or 160 mg of enzalutamide daily.

The primary outcome measure is metastasis-free survival. Secondary outcome measures include OS, time to pain progression, or time to opiate use for prostate cancer pain. Time to first use of cytotoxic chemotherapy or new anti- neoplastic therapy, and time to prostate-specific antigen
(PSA) progression are also collected. This study is expect- ed to enroll 1560 patients at sites throughout the United States. For more information, contact Mohammad Hirmand, MD, at 415-543-3470 or mohammad.hirmand@ medivation.com, or Kristina Wilson at 415-543-3470 or kristina.wilson@medivation.com. The NLM Identifier is NCT02003924.

DCVAC Added to Standard Chemotherapy
The objective of this phase 3, parallel-assignment, double-blind study is to determine whether DCVAC/PCa added to standard-of-care chemotherapy can improve survival times for patients with metastatic castration-resistant prostate cancer. Patients aged ≥18 years with disease pro- gression despite androgen deprivation therapy, a life expectancy of ≥6 months, and an Eastern Cooperative Oncology Group performance status of 0 to 2 may enroll if other criteria are met. Patients are randomized to receive either DCVAC or placebo with standard-of-care therapy consisting of docetaxel and prednisone.

The primary outcome is OS, measured over a time frame of 124 weeks. Secondary outcome measures include radio- graphic progression-free survival (PFS), and duration to PSA progression and skeletal-related events. This trial is expected to enroll 1170 patients at several sites throughout the United States. For more information, contact Richard Kapsa at kapsa@sotio.com. The NLM Identifier is NCT02111577.

Enzalutamide and Mifepristone
This phase 1/2 trial studies the side effects, efficacy, and best dose of enzalutamide and mifepristone combination therapy. Patients aged ≥18 years with metastatic hormone-resistant prostate cancer, an Eastern Cooperative Oncology Group performance status of ≤2, and evidence of castrate testosterone levels at <50 ng/dL may enroll if other criteria are met. Patients are randomized to receive either enzalutamide alone or in combination with mifepristone. Primary outcomes are the recommended phase 2 dose, defined as the highest mifepristone dose in combination with enzalutamide, and PFS. Secondary outcome measures include OS, radiographic PFS, pharmacokinetic parame- ters of the 2 drugs, and the androgen and glucocorticoid receptors’ expressions within circulating tumor cells. This study is expected to enroll 108 patients in Chicago, IL. For more information, contact Kelly O’Connor at 773-702-4653 or koconnor@medicine.bsd.uchicago.edu. The NLM Identi- fier is NCT02012296. Enzalutamide plus Dutasteride as First-Line Treatment
The objective of this phase 2, open-label, single-group assignment study is to determine the effect of enzalutamide and dutasteride on the time to PSA level increase. Patients aged 65 to 85 years with prostate cancer who have a serum testosterone level of >1.7 nmol/L at time of screening and an Eastern Cooperative Oncology Group performance status of 0 to 2 may enroll if other criteria are met. All patients will receive daily enzalutamide and dutasteride orally.

The primary outcome measure is PSA levels, measured from blood drawn every 6 weeks for 103 weeks. This trial is expected to enroll 40 patients in Rochester, NY, and Mil- waukee, WI. For more information, contact Chunkit Fung, MD, at 585-275-9319 or chunkit_fung@urmc.rochester. edu, or Ayesha Khan at 585-275-3351 or ayesha_khan@ urmc.rochester.edu. The NLM Identifier is NCT02213107.

Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate

The purpose of this phase 3, open-label, single-group as- signment trial is to evaluate if leuprolide mesylate for inject- able suspension (LMIS) is safe and effective in the treatment of advanced prostate carcinoma. Patients aged ≥18 years with a baseline morning serum testosterone level of >150 ng/dL and an Eastern Cooperative Oncology Group performance score of ≤2 may enroll if other criteria are met. All patients will be given 2 injections with a depot formulation of LMIS 50 mg at 6 months apart, and are followed until day 336.

The primary outcome measure is efficacy of the study drug. Secondary outcome measures include postsuppres- sion excursions of serum testosterone, and the pharmacoki- netics, safety, and tolerability of LMIS. This study is ex- pected to enroll 130 patients at multiple sites throughout the United States. For more information, contact John Mao, PhD, at 650-421-1016 or john.mao@foreseepharma. com. The NLM Identifier is NCT02234115.

Calcitriol, Ketoconazole, and Hydrocortisone
This single-arm, phase 1/2 trial studies the side effects, best dose, and efficacy of calcitriol when given in combina- tion with ketoconazole and hydrocortisone in patients with advanced or recurrent prostate cancer. Patients aged ≥18 years with an Eastern Cooperative Oncology Group perfor- mance status of 0 to 2 or a Karnofsky performance score of 60% to 100%, a life expectancy >3 months, and hemoglobin ≥8 g/dL may enroll if other criteria are met. All patients will receive oral calcitriol daily according to protocol. Pa- tients will receive ketoconazole orally 3 times a day on days 1 to 24 and days 4 to 24 in phase 1 and 2 of the trial, respectively. Oral hydrocortisone is given in phase 1 of the trial only. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary outcome measures include the maximum toler- ated dose of calcitriol as well as PSA response rate. Second- ary outcome measures are toxicity and objective tumor re- sponse as measured by a monthly physical exam and radiographic evaluation every 12 weeks. This study is ex- pected to enroll 51 patients in Buffalo, NY. For more information, contact Donald L. Trump, MD, FACP, at 877-275- 7724 or askrpci@roswellpark.org. The NLM Identifier is NCT00536991.

Metformin Prostate Cancer Adjuvant Trial

This open-label, phase 2 trial will determine whether metformin can increase the PSA doubling time for patients with prostate cancer who have failed primary treatment with radiation, or surgical patients who are at high risk for recurrence based on surgical pathology. Patients aged ≥18 years with hemoglobin A1c <7.0% who are able to swallow and retain oral medication may enroll if other criteria are met. All patients will receive metformin hydrochloride extended release 750 mg twice a day for 9 months, and are randomized to receive either surgery or radiation. The primary outcome measure is PSA doubling time. The secondary outcome measure is the decrease in PSA levels. All end points are measured for a time frame of 9 months. This study is expected to enroll 70 patients in Mineola, NY. For more information, contact Kaitlin Tietjen, MS, at 516-663-4721 or ktietjen@winthrop.org, or Andrew Ho, BSc, at 516-535-1900 or aho@winthrop.org. The NLM Identifier is NCT02176161. Enzalutamide plus Leuprolide
The purpose of this phase 3, parallel-assignment, double- blind study is to assess the combination of enzalutamide and leuprolide in patients with high-risk, nonmetastatic prostate cancer that progresses after radical prostatectomy, radiotherapy, or both. Patients aged ≥18 years with PSA doubling time ≤9 months and a serum testosterone level of ≥150 ng/dL may enroll if other criteria are met. Patients are randomized to receive enzalutamide plus leuprolide, enzalutamide monotherapy, or placebo plus leuprolide.

The primary outcome measure is metastasis-free survival, measured for up to 56 months. Secondary outcomes include OS, the proportion of patients per group who remain treatment free 2 years after suspension of study drug treatment, and the time to castration resistance. Prostate can- cer–specific survival, time to first symptomatic skeletal event, and safety and adverse event profiles are also mea- sured. This trial is expected to enroll 1860 patients in Tucson, AZ; Omaha, NE; and Myrtle Beach, SC. For more information, contact William Novotny, MD, at 415-983- 3066 or william.novotny@medivation.com, or Christian Lopez at 415-829-4159 or christian.lopez@medivation.com. The NLM Identifier is NCT02319837.

BRAIN CANCER

Perifosine and Temsirolimus for Recurrent/ Progressive Malignant Gliomas

This phase 2, parallel-group, open-label study will assess the effectiveness of temsirolimus and perifosine combination therapy in treating recurrent or progressive brain tu- mors. Patients aged ≥18 years who have received previous radiotherapy and temozolomide for the treatment of malig- nant glioma and who have (1) a Karnofsky performance score of ≥70, (2) a life expectancy >8 weeks, (3) normal organ and marrow function, and (4) adequate renal and liver function may enroll if other criteria are met. Patients are randomized to receive cytoreductive surgery or no procedure. After antiemetic prophylaxis, both groups will re- ceive perifosine according to protocol.

Primary outcome measures include radiographic response and 6-month PFS. The secondary outcome measure is median OS, measured from the time the study drug is first administered for up to 48 months or until the patient dies. This study is expected to enroll 17 patients in New York City. For more information, contact Andrew B. Lassman, MD, at 212-342-0571 or ABL7@cumc.columbia.edu. The NLM Identifier is NCT02238496.

Valproic Acid, Radiation, and Bevacizumab in Children
This phase 2, single-group, open-label trial examines whether the combination of valproic acid and bevacizumab with surgery and radiation will reduce brain tumors more effectively and improve the possibility of cure. Patients 3 to 21 years of age with high-grade gliomas who have not re- ceived previous chemotherapy, radiation, biologic therapy, or bone marrow transplants, and who have a Karnofsky or Lansky performance score of ≥50 within 2 weeks of study enrollment may participate if other criteria are met.

Patients will be encouraged to have the maximal surgical resection that can be performed safely before entering into the study. All patients will receive valproic acid in a dose-escalation sequence and bevacizumab intravenously every 2 weeks during the maintenance phase, for a maxi- mum of 24 months. Radiation therapy will start within 30 days of the patient’s definitive surgical procedure. Primary outcome measures are event-free survival and valproic acid toxicity, assessed over a time frame of 24 months. This study is expected to enroll 56 patients in Oklahoma City, OK, and at various sites throughout Texas. For more in- formation, contact Jack Su, MD, at 832-822-4306 or jmsu@txch.org, or Susan Blaney, MD, at 832-822-4586 or smblaney@txch.org. The NLM Identifier is NCT00879437.

Palbociclib Isethionate for Treatment of Younger Patients
The goal of this phase 1, open-label study is to characterize the side effects and best dose of palbociclib isethionate in treating younger patients with recurrent, progres- sive, or refractory brain tumors. Patients aged 4 to 21 years who received their last dose of myelosuppressive anticancer chemotherapy ≥3 weeks, nitrosourea ≥6 weeks, or biologic agent ≥7 days before enrolling in the trial are eligible to participate if other criteria are met. All patients will re- ceive the study drug daily on days 1 to 21. This treatment repeats every 28 days for 26 courses in the absence of dis- ease progression or unacceptable toxicity.

Primary outcomes are the maximum tolerated dose of palbociclib isethionate and the incidence of adverse events, both assessed for a time frame of 4 weeks to 1 month. Secondary outcome measures are objective responses (ie, partial and complete response), and individual and population pharmacokinetic parameters. This study is expected to enroll 40 patients in several locations through- out the United States. For more information, contact Wint M. Swe, MBA, MBBS, at wint.swe@stjude.org. The NLM Identifier is NCT02255461.

Postapproval Study of NovoTTF-100A
The purpose of this phase 4, nonrandomized, parallel- assignment study is to confirm that the efficacy of the NovoTTF-100A System in patients with recurrent glioblastoma multiforme is comparable to that of basic standard- of-care (BSC) chemotherapy. Patients aged ≥22 years with a Karnofsky performance score of ≥70, a histologic diagnosis of glioblastoma multiforme, and who have received maximal, safe, surgical resection; radiation therapy; and concomitant and maintenance temozolomide may enroll if other criteria are met. Patients will receive either BSC or NovoTTF-100A monotherapy.

The primary outcome is OS, measured 5 years from initiation of accrual. Secondary outcome measures include the change in neurocognitive function from baseline, genetic profiling of tumors and correlation with response to treatment, and the adverse event profile. This study is ex- pected to enroll 486 patients at sites throughout the Unit- ed States. For more information, contact Ghazala Kabani at patientinfo@novocure.com. The NLM Identifier is NCT01756729.

Photodynamic Therapy for Brain Tumors
This phase 1, open-label study evaluates the maximum tolerated dose and preliminary effectiveness trends of photodynamic therapy (PDT) in children. Patients aged 6 months to 18 years with relapsed or refractory brain tumors and potentially resectable disease, and whose disease does not have a known curative therapy or therapy proven to prolong survival with an acceptable quality of life may en- roll if other criteria are met. All patients will receive intra- venous Photofrin in a dose-escalation manner approximately 24 hours before tumor resection surgery and PDT.

The primary outcome measure is the maximum tolerated dose of Photofrin in pediatric patients. Dose-limiting toxicities observed can include neurotoxicity, photosensitivity, ocular sensitivity, and any other toxicity ≥grade 4 within the same period. The secondary outcome measure is brain tumor response occurring within 3 years of receiving PDT. This trial is expected to enroll 24 patients in Wauwatosa, WI. For more information, contact Michael E. Kelly, MD, PhD, at 414-266-6471 or mekelly@mcw.edu. The NLM Identifier is NCT01682746.

Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin
The objective of this phase 1, open-label study is to determine the side effects and best dose of genetically modified neural stem cells (NSCs) and flucytosine in combina- tion with leucovorin. Patients aged ≥18 years with recurrent, high-grade gliomas may enroll if other criteria are met. All patients will receive NSCs intracranially on days 1 and 15. Flucytosine is given orally on days 4 to 10 and 18 to 24. Patients may be given leucovorin orally, de- pending on when they enter the study.

Primary outcome measures include the maximum tolerated dose and incidence of dose-limiting toxicities, the incidence of all adverse events and toxicities, and clinically significant allergic reactions to NSCs. Secondary outcome measures include T-cell responses, antibodies against NSCs, and pharmacokinetic parameters. This trial is expected to enroll 24 patients in Duarte, CA. For more information, contact Alexandra Ching, NP, at 626- 471-9393 or neuro surgery@coh.org. The NLM Identifier is NCT02015819.

Veliparib, Radiation Therapy, and Temozolomide for Younger Patients

This phase 1/2 trial studies the side effects and best dose of veliparib in younger patients when given with radiation therapy and temozolomide. Patients aged ≤21 years who have newly diagnosed diffuse intrinsic pontine gliomas, have a Karnofsky or Lansky performance score of ≥50 (for patients >16 years of age or ≤16 years of age, respectively), and are treatment-naïve except for surgery and/or steroids may enroll if other criteria are met. All patients will receive a dose escalation of veliparib orally 5 days a week for 6 to 7 weeks. During maintenance therapy, all patients will receive veliparib and temozolomide on days 1 to 5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.

Primary outcome measures are the maximum tolerated dose of veliparib, the feasibility of intrapatient dose esca- lation of temozolomide during maintenance therapy with veliparib, and OS. Secondary outcomes are PFS, number of pseudoprogression cases, and the pharmacokinetic parameters of veliparib. This study is expected to enroll 66 patients at multiple locations throughout the United States. For more information, contact Patricia A. Baxter at 832-824-4681 or pabaxter@txch.org. The NLM Identi- fier is NCT01514201.

Selumetinib in Young Patients with Recurrent or Refractory Low-Grade Glioma

This phase 1/2, single-group, open-label trial evaluates the side effects and best dose of selumetinib and its efficacy in the treatment of recurrent or refractory low-grade glioma. Patients aged 3 to 21 years who have not received myelosuppressive anticancer chemotherapy for ≤3 weeks or a nitrosourea for ≤6 weeks before study registration may enroll if other criteria are met. All patients will receive selumetinib orally twice daily on days 1 to 28. Courses re- peat every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

Primary outcome measures are the maximum tolerated dose and recommended phase 2 dose of selumetinib (as de- termined by dose-limiting toxicities), the stratum-specific objective response rate sustained for 8 weeks, objective re- sponse, and disease stabilization rates. Secondary outcome measures include plasma drug concentrations and pharmacokinetic parameters, stratum-specific PFS distribution, the presence or absence of BRAF V600E mutations or BRAF KIAA1549 fusion, and PFS in patients with recurrent dis- ease. This trial is expected to enroll 135 patients. For more information, contact Jason R. Fangusaro at 312-227-4846 or jfangusaro@luriechildrens.org. The NLM Identifier is NCT01089101.

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