Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma
Summary
Primary Objective:
1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate
Secondary Objectives:
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
2. To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma
Exploratory Objectives:
1. To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET
2. To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Soft Tissue Sarcoma
Intervention
Glufosfamide
Location
Premiere Oncology of Arizona
Scottsdale
Arizona
United States
85260
Status
Completed
Source
Threshold Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00441467
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Soft Tissue Injuries
Injuries of tissue other than bone. The concept is usually general and does not customarily refer to internal organs or viscera. It is meaningful with reference to regions or organs where soft tissue (muscle, fat, skin) should be differentiated from bones or bone tissue, as "soft tissue injuries of the hand".
Soft Tissue Infections
Infections of non-skeletal tissue, i.e., exclusive of bone, ligaments, cartilage, and fibrous tissue. The concept is usually referred to as skin and soft tissue infections and usually subcutaneous and muscle tissue are involved. The predisposing factors in anaerobic infections are trauma, ischemia, and surgery. The organisms often derive from the fecal or oral flora, particularly in wounds associated with intestinal surgery, decubitus ulcer, and human bites. (From Cecil Textbook of Medicine, 19th ed, p1688)
Neoplasms, Connective And Soft Tissue
Neoplasms developing from some structure of the connective and subcutaneous tissue. The concept does not refer to neoplasms located in connective or soft tissue.
Leiomyosarcoma
A sarcoma containing large spindle cells of smooth muscle. Although it rarely occurs in soft tissue, it is common in the viscera. It is the most common soft tissue sarcoma of the gastrointestinal tract and uterus. The median age of patients is 60 years. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1865)
Suture Anchors
Implants used in arthroscopic surgery and other orthopedic procedures to attach soft tissue to bone. One end of a suture is tied to soft tissue and the other end to the implant. The anchors are made of a variety of materials including titanium, stainless steel, or absorbable polymers.
Clinical Trials
Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer
The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.
Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme
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Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
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Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)
The aims of this trial are to evaluate the efficacy of bendamustin in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-baesd chemotherapy a...
Placebo Controlled Study of Antibiotic Treatment of Soft Tissue Infection
This study is to determine whether antibiotic therapy is needed for patients with non-life threatening soft tissue infections. Most patients with these soft tissue infections are presently...
PubMed Articles
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Intraoperative ultrasonography is a useful tool for the detection and extirpation of liver metastases, breast masses, and melanoma. However, the efficacy of this technology in intraoperative localizat...
Imaging of soft tissue abnormalities about the hip.
Soft tissue abnormalities about the hip represent a common clinical problem. Although the signs and symptoms of some of these abnormalities are clinically evident, other entities are frequently overlo...
Glufosfamide : can we improve the process of anticancer agent development?
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Excessive soft tissue bulk, movement, chronic inflammation, and hypertrophy in periimplant areas pose challenges for long-term management of peri-implant soft tissues surrounding osteocutaneous flap r...
