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Annotations by Tom Swartz
[Editor's Note: We made a substantial change in mid-October 2006 in the way in which we are providing clinical trial information in ESUN and on our website. Although these changes were described in the October issue of ESUN, we think they should be mentioned one more time. Because the Clinical Trial News column is so highly accessed, we have reduced the need for you to "search" back issues of ESUN to locate clinical study information. We have created three separate webpages where all of the clinical trial information that we have published in ESUN to date has been collected. You can read about these changes in the editorial, Changes Made, in the October 2006 issue of ESUN. With the addition of the 9 clinical trials described in this issue of ESUN, we now have over 170 clinical trials listed on our website.]
Currently Accepting Eligible Patients (not previously published in ESUN)
This Phase I trial is currently recruiting patients. This is a phase I dose escalation study designed to evaluate the safety, tolerance, pharmacokinetics, and anti-cancer effects of HGS-ETR2 in eligible pediatric patients aged 1 through 21 years old with refractory solid tumors. HGS-ETR2 will be administered as a 60-minute intravenous infusion on Days 1 and 15 of each 28-day cycle following premedication of acetaminophen and diphenhydramine. The starting dose will be 3 mg/kg, with interpatient dose escalation up to 10 mg/kg until the MTD is reached; no intrapatient dose escalation will be permitted. Once the MTD is reached, the MTD cohort will be expanded to include 12 patients (with at least 6 patients less than 12 years old). This trial is taking place at the NIH Clinical Center in Bethesda, Maryland. For additional information call NCI's Pediatric Oncology Branch at 1-877-624-4878.
Sirolimus in Treating Patients With Metastatic or Unresectable Solid Tumors This Phase I trial is currently patients. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is studying the side effects and best dose of sirolimus in treating patients with metastatic or unresectable solid tumors. This is a prospective, dose-escalation study. Patients receive oral sirolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. The pharmacodynamic optimal dose is considered the dose at which 10 patients are treated without requiring further dose escalation. Patients undergo blood collection, tumor tissue and normal skin biopsies, and oral mucosal smears periodically for pharmacodynamic, pharmacokinetic, and biomarker correlative studies. After completion of study treatment, patients are followed at 4 weeks. A total of 30 patients will be accrued for this study. Patients 18 years and older are eligible. This trial is taking place at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.
Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma This Phase II trial is currently recruiting patients. Letrozole is an aromatase inhibitor. Aromatase is the enzyme that produces estrogen in post-menopausal women. By interfering with the production of estrogen triggered by aromatase, letrozole reduces the total amount of estrogen in the body. As a result, less estrogen can reach cancer cells, thus preventing their growth. This trial is for patients with uterine leiomyosarcoma with disease limited to the uterus (determined by surgical staging or radiologic imaging). Other inclusion criteria include: (1) Tumors must express ER positivity by immunohistochemistry (ER expression >10% by immunohistochemistry); (2) Patients must have a hysterectomy and bilateral oophorectomy prior to initiation of therapy; and (3) All patients must have no measurable disease. If you are found to be eligible to take part in this study, you will be randomly assigned to 1 of 2 groups. Group 1 will receive letrozole by mouth once a day. Group 2 will receive no treatment. Both groups will be followed closely every 3 months. If you are in Group 1, you will take letrozole by mouth every day for 12 weeks. Every 12 weeks is considered a study "cycle." You will only be given the amount of drug needed for 1 cycle of therapy at a time. You will keep a diary during the study that will list when and how much drug you took. This diary will be reviewed after each cycle of therapy by the research nurse or doctor and filed in your chart. Every 12 weeks, all participants will have blood (about 3-4 teaspoons) drawn for routine tests and a CT scan of the chest, abdomen (stomach area), and pelvis. In addition, all participants will have a physical exam (including a pelvic exam), and your vital signs and blood pressure will be measured. Every 6 months you will also have a chest x-ray. You may remain on study for as long as you are benefiting. You will be taken off study if intolerable side effects occur. Once you are off study, blood (about 2-3 teaspoons) will be drawn for routine tests and to measure your cholesterol level. You will have a physical exam (including a pelvic exam), and an MRI or CT scan. This is an investigational study. Letrozole is approved by the FDA for treatment of some breast cancer patients after surgery. Its use in patients with leiomyosarcoma is experimental. Letrozole will be provided to you free of charge while you are on study. Up to 80 patients will take part in this study. Patients 18 years of age and older are eligible. This trial is taking place at New York Presbyterian Hospital, New York, New York, and M.D. Anderson Cancer Center, Houston, Texas.
This Phase II trial is currently recruiting patients. Localized solid tumors such as, sarcoma, neuroblastoma, and Wilms’ tumor, can generally be effectively treated with a combination of surgery, radiation and chemotherapy. However, patients with metastatic or relapsed disease have a very poor prognosis. New approaches to the management of these difficult groups of patients are needed. There is evidence to suggest that solid tumors may be good candidates for immunotherapy approaches. In fact, recent experimental evidence indicates that the period of lymphopenia that occurs after stem cell transplant may be an opportune time to use an immunotherapy treatment approach. In light of the very poor prognosis of young patients with advanced solid tumors, this treatment approach warrants further investigation. To participate in this study, it is necessary to collect sufficient tumor and peripheral blood stem cells to both develop the vaccine and perform the autologous stem cell transplant. Patients who also have previously had tumor or stem cells collected, which are available and sufficient for this study, are eligible to participate as study subjects. Patients must have a histologically verified diagnosis of neuroblastoma, Wilm’s tumor, or soft tissue sarcoma, including rhabdomyosarcoma, a Ewing’s sarcoma family tumor (ES, PNET), synovial sarcoma, fibrosarcoma, or desmoplastic round cell tumor, and must meet one of the following criteria: (1) have metastatic disease at diagnosis;(2) have never achieved complete remission following frontline standard therapy, and (3) have relapsed after receiving standard therapy. Patients less than 30 years of age are eligible. The total expected enrollment is 30 patients. This trial is taking place at the University of Michigan, Department of Surgery, Pediatric Section, Ann Arbor, Michigan.
Phase I Study of PXD101 in Patients With Advanced Solid Tumors This Phase I trial is currently recruiting patients. PXD101 (Belinostat) is a novel investigational small molecule drug that inhibits the enzyme histone deacetylase (HDAC). PXD101 has been shown in preclinical studies to have the potential to treat a wide range of solid and hematologic malignancies either as a monotherapy or in combination with other active agents, and both an oral and intravenous formulation of the drug are being evaluated in clinical trials. For additional information, click here. The objectives of this study are to determine the safety, tolerability and pharmacokinetics of orally administered PXD101 and to establish a Maximum Tolerated Dose (MTD) for once daily dosing and twice daily dosing in patients with advanced solid tumors. Cohorts of 3–6 patients (depending on tolerability) with advanced solid tumors will be dosed in 28 day (4 week) cycles. At a minimum, 3 patients will be required at each dose level. If a dose level is reached where 1 of 3 patients experience a Dose Limiting Toxicity (DLT), it will be expanded with 3 additional patients. A total of up to 100 patients are planned for study enrollment. Patients 18 years of age and older are eligible. This trial is taking place at centers in Connecticut, New York, Texas, Denmark, and the United Kingdom.
A Phase I Study of PXD101 Alone and in Combination With 5-FU in Patients With Advanced Solid Tumors This Phase I trial is currently recruiting patients. PXD101 (Belinostat) is a novel investigational small molecule drug that inhibits the enzyme histone deacetylase (HDAC). PXD101 has been shown in preclinical studies to have the potential to treat a wide range of solid and hematologic malignancies either as a monotherapy or in combination with other active agents, and both an oral and intravenous formulation of the drug are being evaluated in clinical trials. For additional information, click here. The primary goal of the study is to understand safety, anti-tumor activity, and how the study drug behaves within the body in patients with advanced solid tumors alone and in combination with 5-FU. A total of up to 40 patients is planned for enrollment. Patients 18 years of age and older are eligible. This trial is taking place at centers in Arizona, Nebraska, and New Hampshire.
BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors This Phase I trial is currently recruiting patients. Monoclonal antibodies, such as BB-10901, 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 trial is studying the side effects and best dose of BB-10901 in treating patients with relapsed or refractory solid tumors. This is an open-label, multicenter, dose-escalation study. Patients receive BB-10901 IV over 40 minutes once daily on days 1-3.* Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (*NOTE: Patients who do not tolerate 3 consecutive daily infusions of BB-10901 may receive infusions of BB-10901 on 3 alternate days, upon approval by the investigator and/or the independent Safety Review Board). Cohorts of 4-6 patients receive escalating doses of BB-10901 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4-6 patients experience dose-limiting toxicity in course 1. Up to 12 patients are treated at the MTD. After completion of study treatment, patients are followed at 28 days. A total of 44 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at centers in Massachusetts, Texas, and the United Kingdom.
This Phase I trial is currently recruiting patients. Intravenous VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer. This trial is studying the side effects of VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma. This is an open-label, multicenter, extension study. Patients receive VEGF Trap* IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. (*NOTE: Patients receive the same drug dose that they received in MSKCC-03137 [VGFT-ST-0202]). Patients are followed monthly for 3 months. A total of 25 patients will be accrued for this study within 3-6 months. Patients 18 years of age and older are eligible. This trial is taking place at Memorial Sloan-Kettering Cancer Center, New York, and Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.
Study of Oral AEE788 in Adults With Advanced Cancer This Phase I trial is currently recruiting patients. AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity of AEE788 in advanced cancers. The total expected enrollment is 233 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in Connecticut, Nevada, Tennessee and Texas.
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