Sunitinib in Soft Tissue Sarcoma
Summary
The purpose of this study is to determine the clinical response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent vascular soft tissue sarcoma treated with sunitinib.
Description
This is a Phase II, open label, nonrandomized single institution study to determine efficacy and toxicity of sunitinib in certain subtypes of soft tissue sarcomas. Patients are stratified according to sarcoma histology (angiosarcoma vs. hemangioendothelioma vs. Kaposi's sarcoma).
The purpose of this study is to determine the clinical response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent vascular soft tissue sarcoma treated with sunitinib. Secondary objectives will be to 1) To determine 3 month and 6 month progression free survival, defined as patients that are alive and without evidence of progression of disease on reassessment of disease after while being treated; 2) To determine overall survival of patients treated with this regimen; 3) To determine safety and tolerability of sunitinib in this patient population.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Sarcoma, Soft Tissue
Intervention
Sunitinib
Location
Columbia University Medical Center
New York
New York
United States
10032
Status
Recruiting
Source
Columbia University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00859456
- 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
Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma
This research is being done with the aim of developing a more effective treatment than standard radiotherapy and surgery alone. Although standard treatment is frequently successful, some p...
Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 th...
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...
The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Advanced Soft Tissue Sarcoma.
PubMed Articles
Treatment of Multidrug Resistant Advanced Alveolar Soft Part Sarcoma With Sunitinib.
Sunitinib is a tyrosine kinase/angiogenesis inhibitor with proven efficacy in gastrointestinal stromal tumor and advanced renal cell carcinoma. We are presenting the case report of a patient with aggr...
Sunitinib is a tyrosine kinase inhibitor for GIST and advanced renal cell carcinoma. Diclofenac is used in cancer pain management. Coadministration may mediate P450 toxicity. We evaluate their interac...
Multimodality therapy concepts for soft tissue sarcomas.
Despite the fact that soft tissue sarcomas are representing a rare tumor entity with a low incidence rate of about 2-4 per 100.000 per year, they highly require a multimodality therapeutic approach. B...
Sunitinib-induced hyperammonaemia in a patient with pancreatic neuroendocrine tumour.
WHAT IS KNOWN AND OBJECTIVE: Sunitinib can improve progression-free survival and overall survival in patients with advanced pancreatic neuroendocrine tumor (PNET). From clinical trial, most commonly r...
Soft Tissue Sarcomas in Children.
Pediatric soft tissue sarcomas (STS) are a heterogeneous group of malignant tumors constituting about 7% of all cancer cases. Rhabdomyosarcomas (RMS) constitute about half of all soft tissue sarcomas...
