Abstracts by Tom Swartz

[Editor's Note: 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 180 clinical trials listed on our website.]

Currently Accepting Eligible Patients (not previously published in ESUN)

Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

This Phase II trial is currently recruiting patients. Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining (known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations. The expected total enrollment is 45 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in the District of Columbia, Illinois, Indiana, Massachusetts, Michigan, New York, and Pennsylvania.

Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma

This Phase II trial is currently recruiting patients. This is an open label single site clinical trial to identify a potentially promising therapy dose for Sunitinib malate. All patients with unresectable or metastatic Soft tissue sarcoma: leiomyosarcoma, liposarcoma, fibrosarcoma, and MFH seen at the H. Lee Moffitt Cancer Center will be screened for eligibility to be enrolled in the study. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity which in the opinion of the treating physician or the trial PI compromises the ability of the patient to receive treatment or the patient desires to stop treatment. An office visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count and differential, comprehensive metabolic panel, and ECG will be obtained at every scheduled visit. The expected total enrollment is 48 patients. Patients 18 years of age and older are eligible. This trial is taking place at the H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida.

E7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue Sarcoma

This Phase II trial is currently recruiting patients. E7389 is a synthetic analogue of halichondrin B, a substance derived from a marine sponge (Lissodendoryx sp.) with antineoplastic activity. E7389 binds to the vinca domain of tubulin and inhibits the polymerization of tubulin and the assembly of microtubules, resulting in inhibition of mitotic spindle assembly, induction of cell cycle arrest at G2/M phase, and, potentially, tumor regression. In this study, patients with advanced/metastatic soft tissue sarcoma will be treated with E7389 on Days 1 and 8 every 21 Days. The total expected enrollment is 150 patients. Patients 18 years of age and older are eligible. The following sarcomas are not eligible: embryonal rhabdomyosarcoma; chondrosarcoma; osteosarcoma; Ewing tumors/PNET; gastro-intestinal stromal tumors; dermatofibrosarcoma protuberans; inflammatory myofibroblastic sarcoma. This trial is taking place in Belgium.

A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

This Phase II trial is currently recruiting patients. This is a study of perifosine in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg orally qhs with food until disease progression. Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food. Administering the drug qhs has been shown to decrease gastrointestinal toxicity in some patients. Patients may need anti-emetics and/or anti-diarrheals. All patients may continue therapy unless disease progression is documented on two occasions at least 4 weeks apart. Patients who experience toxicity may continue on treatment with doses delayed or reduced. Evaluation of all lesions for progression or response will be made at 3-month intervals. Treatment will be administered on an outpatient basis in 28-day cycles. Growth factors should not be needed; however, use by patients on this trial is not prohibited. A favorable outcome will be defined as a complete or partial response according to the Choi criteria or stable disease by the Choi criteria for 6 months or longer. The expected total enrollment is 111 patients. Patients 13 years of age and older are eligible. This trial is taking place at centers in California, District of Columbia, Pennsylvania, and Texas.

Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma

This tissue collection study is currently recruiting patients. The purpose of this study is to collect and store tumor tissue, blood, and bone marrow samples from patients with soft tissue sarcoma that will be tested in the laboratory. Patients 50 years old and younger are eligible. Patients with Ewing’s sarcoma/primitive neuroectodermal tumor and osteogenic sarcoma are not eligible. Tumor tissue, blood, and bone marrow samples will be taken from the patient at the time of cancer diagnosis or relapse and kept for future use in studying cancer. Some patients will also have information on their response to treatment collected twice a year for at least 10 years. The trial is taking place at centers in Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Australia, Canada, New Zealand, Puerto Rico, and Switzerland.

Study of Dasatinib in Patients With Advanced Solid Tumors

This Phase I trial is currently recruiting patients. This trial has two Segments. The purpose of Segment 1 of the study is to determine the effect of ketoconazole on dasatinib. The purpose of Segment 2 is to learn how dasatinib affects tumor growth in patients with advanced solid tumors. The primary outcomes are as follows - Segment 1: Determine whether the steady state pharmacokinetics of 20 mg of dasatinib are affected by co-administration with ketoconazole in patients with advanced solid tumors; Segment 2: Assess the pharmacodynamic activity of dasatinib. The secondary outcomes are as follows - Segment 1: Evaluate the safety and tolerability of dasatinib alone and when co-administered with ketoconazole; Segment 2: Explore the association between tumor response and the pre-clinically identified markers and other mRNA gene expression level. The expected total enrollment is 60 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, Florida, Tennessee, and Texas.

Study of ZIO-201 in Advanced Sarcoma

This Phase I/II trial is currently recruiting patients. ZIO-201 is a proprietary formulation of isophosphoramide mustard (IPM), the active metabolite of ifosfamide being developed by Ziopharm Oncology. Ifosfamide is an alkylating drug used to treat diverse cancers including testicular cancer, sarcoma, and lymphoma. Preclinical studies have shown that ZIO-201 has activity in leukemia and solid tumor cancers. These studies also indicate that ZIO-201 has a better safety profile than ifosfamide, likely because the toxic metabolites of ifosfamide, acrolein and chloroacetaldehyde are not present in ZIO-201. Zioppharm believes the administration of ZIO-201 may avoid many of the toxicities of ifosfamide without compromising the activity of the drug. The purpose of this trial is thus to study safety of ZIO-201 in the treatment of advanced sarcoma. Patients 18 years of age and older with metastatic and/or unresectable disease state after previous standard chemotherapy are eligible. The treatment protocol is not yet provided. For additional information contact: Jan Stevens, RN 617-259-1983; Jill Buck 617-259-1984. The trial is taking place in Ann Arbor, Michigan.

Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

This Phase II trial is currently recruiting patients. Glufosfamide is a small molecule conjugate of the ifosfamide alkylator and glucose which may enter cells through upregulated glucose transport proteins. It is being developed by Threshold Pharmaceuticals. The primary objective of this study is to evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate. Secondary objectives are: (1) to evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response, progression-free survival and overall survival; and (2) to evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma. Exploratory objectives are: (1) to evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET; and (2) to correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins. Patients 18 years of age and older are eligible. Soft tissue sarcomas of the following subtypes are excluded: gastrointestinal stromal tumor (GIST), alveolar soft parts sarcoma, hemangiopericytoma and Kaposi’s sarcoma. This trial is taking place at centers in Arizona, California, Florida, Missouri, New Mexico, and New York.

A Phase I, Open-Label, Dose Finding Study Evaluating the Safety and Pharmacokinetics of AMG 479 in Subjects with Advanced Solid Tumors

This Phase I trial is currently recruiting patients. The purpose of this study is to determine the best and safest dose of AMG 479 and how often it should be taken. AMG 479 is a monoclonal antibody. Monoclonal antibodies can locate and bind to cells wherever they are in the body. Many monoclonal antibodies are used in finding or treating cancer cells. The study drug blocks the interaction of insulin like growth factors with their receptor (the insulin like growth factor type 1 receptor). AMG 479 has been shown to stop the growth of cancer cells in several laboratory tests. This is the first time that AMG 479 has been given to humans. This study involves two parts. In Part One, called dose escalation, the purpose is to test the safety of AMG 479 at different doses. It is expected that 3 subjects will be in each group for each dose tested. In Part Two, called dose expansion, patients will be given one of the two highest doses from Part One that also were found to be safe. The purpose is to see what effects (good or bad) these doses of AMG 479 have on the patient and their cancer, and to learn more about how it works in the body. If a patient is eligible and participates, there is a 100% chance that they will receive AMG 479. Patients 18 years of age and older are eligible. About 50 patients will take part in this study. This trial is taking place at Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.

Brostallicin or Doxorubicin as First-Line Therapy in Treating Patients With Relapsed, Refractory, or Metastatic Soft Tissue Sarcoma

This Phase II trial is currently recruiting patients. Drugs used in chemotherapy, such as brostallicin and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. The purpose of this trial is to study the side effects and how well brostallicin or doxorubicin works as first-line therapy in treating patients with relapsed, refractory, or metastatic soft tissue sarcoma. This is a randomized, multicenter study. Patients are stratified according to participating and age (younger than 60 years vs. 60 years and over). Patients are randomized to 1 of 2 treatment arms.

	Arm I: Patients receive brostallicin IV over 10 minutes on day 1.
	Arm II: Patients receive doxorubicin hydrochloride IV over 10 minutes on day 1. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter. A total of 108 patients will be accrued for this study. The expected total enrollment is 108 patients. Patients 18 years of age and older are eligible. This trial is taking place at Leiden University Medical Center, Leiden, Netherlands.

Not Yet Recruiting Patients (not previously published in ESUN)

There are no entries in this category for the April 2007 Issue of ESUN.

V4N2 ESUN Copyright © 2007 Liddy Shriver Sarcoma Initiative.