In this context, the term soft tissue refers to tissues that connect, support, or surround other structures and organs of the body. Soft tissue includes muscles, tendons (bands of fiber that connect muscles to bones), fibrous tissues, fat, blood vessels, nerves, and synovial tissues (tissues around joints).

There are many different kinds of soft tissue sarcomas. They are grouped together because they share certain microscopic characteristics, produce similar symptoms, and are generally treated in similar ways. (Bone tumors, also known as osteosarcomas, are also called sarcomas, but are in a separate category because they have different clinical and microscopic characteristics and are treated differently.)

Sarcomas can invade surrounding tissue and can metastasize (spread) to other organs of the body, forming secondary tumors. The cells of secondary tumors are similar to those of the primary (original) cancer. Secondary tumors are referred to as "metastatic soft tissue sarcoma" because they are part of the same cancer and are not a new disease.

Some tumors of the soft tissue are benign (noncancerous). These tumors do not spread and are rarely life-threatening. However, benign tumors can crowd nearby organs and cause symptoms or interfere with normal body functions.

What are the possible causes of soft tissue sarcomas?

Scientists do not fully understand why some people develop sarcomas while the vast majority do not. However, by identifying common characteristics in groups with unusually high occurrence rates, researchers have been able to single out some factors that may play a role in causing soft tissue sarcomas.

Studies suggest that workers who are exposed to phenoxyacetic acid in herbicides and chlorophenols in wood preservatives may have an increased risk of developing soft tissue sarcomas. An unusual percentage of patients with a rare blood vessel tumor, angiosarcoma of the liver, have been exposed to vinyl chloride in their work. This substance is used in the manufacture of certain plastics.

In the early 1900s, when scientists were just discovering the potential uses of radiation to treat disease, little was known about safe dosage levels and precise methods of delivery. At that time, radiation was used to treat a variety of noncancerous medical problems, including enlargement of the tonsils, adenoids, and thymus gland. Later, researchers found that high doses of radiation caused soft tissue sarcomas in some patients. Because of this risk, radiation treatment for cancer is now planned to ensure that the maximum dosage of radiation is delivered to diseased tissue while surrounding healthy tissue is protected as much as possible.

Researchers believe that a retrovirus plays an indirect role in the development of Kaposi's sarcoma, a rare cancer of the cells that line blood vessels in the skin and mucus membranes. Kaposi's sarcoma often occurs in patients with AIDS (acquired immune deficiency syndrome). AIDS-related Kaposi's sarcoma, however, has different characteristics and is treated differently than typical soft tissue sarcomas.

Sponsored by: Abbott Laboratories

Purpose: The primary objective of this study is to assess the safety and effectiveness of ABT-510 in subjects with locally advanced or metastatic soft tissue sarcoma.

Study Type: Interventional

Study Design: Treatment

Ages eligible for study: 18 years and above, both genders

Inclusion Criteria:

* The subject is at least 18 years of age.

* The subject has histologically confirmed high grade locally advanced or metastatic soft tissue sarcoma (excluding Ewing's sarcoma and chondrosarcoma) not amenable to surgery, radiotherapy or combined modality therapy with curative intent.

* The subject must have at least one lesion with measurable disease by RECIST criteria using CT or MRI.

* The subject has received no more than two cytotoxic treatment regimens, not including adjuvant therapy for sarcoma.

* The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.

* The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.

* The subject must have adequate bone marrow, renal and hepatic function as follows: *Bone marrow: White blood cell count (WBC) greater than or equal to 3,000/[mm.sup.3]; * Platelets; greater than or equal to 100,000/[mm.sup.3]; * Hemoglobin greater than or equal to 9.0 g/dL; * Renal function: Serum creatinine less than or equal to 2.0 mg/dL; * Hepatic function: Bilirubin less than or equal to 1.5 mg/dL; AST and ALT less than or equal to 1.5 X the upper normal limit (ULN) unless liver metastases are present, then AST and ALT less than or equal to 5.0 x ULN.

* The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy.

* The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.

Exclusion Criteria:

* The subject has known Central Nervous System (CNS) metastasis. Brain CT or MRI within 28 days of enrollment is required to confirm absence of CNS metastases. Subjects with previously treated brain metastases are eligible if no evidence of disease is observed on CT.

* The subject has received any therapy for sarcoma including chemotherapy, radiotherapy or any investigational therapy administration.

* The subject exhibits evidence of clinically significant uncontrolled condition(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.

* Subject has history of other previous malignancies within five years, with the exception of: * Adequately treated in situ carcinoma of the cervix uteri; * Basal or squamous cell carcinoma of the skin.

* The subject's life expectancy is less than 12 weeks.

Location and Contact Information

Ray Knight, BS MBA Tel: 847-938-1378 E-mail: raymond.knight@abbott.com

Michigan

Study ID Numbers M02-534

NLM Identifier NCT00061659

Return to Soft tissue sarcoma

Home

Contact

Resources

Exchange Links

ebay