Protocol

SARC012: A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional Phase II.5 Study of Saracatinib (AZD0530), a Selective Src Kinase Inhibitor, In Patients with Recurrent Osteosarcoma Localized to the Lung

Diseases

Solid Tumor : recurrent osteosarcoma

Description

The most common site to which osteosarcoma spreads, or metastasizes, is the lungs. The most common site of recurrence is also the lungs. This study is being done to find out if an experimental drug, saracatinib, will decrease the chances that osteosarcoma will come back in the lungs after it has already come back in the lungs once.

Saracatinib is an experimental drug that limits the movement of some cancer cells in the laboratory and decreases the spread of some tumors in mice. Saracatinib works by inhibiting a protein known as Src. Src is thought to be important for the survival of osteosarcoma cells. Some adult patients with cancer who received saracatinib had slowing of growth of their tumor. The study team does not know if saracatinib will be effective for patients with osteosarcoma. This is a randomized, double-blinded, placebo-controlled trial. This means that half of the patients will receive saracatinib and half of the patients will receive placebo (a sugar pill). Neither the patient nor the trial investigators will know if the patient is receiving saracatinib or placebo.

Objectives

• To determine if the addition of saracatinib can decrease the chance that the patient’s tumor will come back.
• To determine if the addition of saracatinib results in an increase in survival.
• To evaluate tumor samples to see if saracatinib caused less Src to be present.
• To test tumor samples to see if a characteristic pattern of genes, or changes in DNA in your tumor, can be identified that might help researchers understand why osteosarcoma comes back.
• To attempt to grow some osteosarcoma cells in laboratory experiments in order to study why it grows and how we can stop it from growing.

Eligibility

• Patients who have recurrence of osteosarcoma, localized to the lungs, who have had complete surgical removal of all lung nodules, are eligible for enrollment.
• Age >15 and <75 years of age
• Informed consent: all patients, or their legal guardian if the patient is less than 18 years of age, must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study
• If the patient has Paget’s disease or has metastatic disease in other locations in addition to the lung they will not be eligible for the study.
• Pregnant women or breast-feeding or nursing women will not be eligible for the study

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Sheri L. Spunt, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
Fax: 901-595-4011

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.