Protocol Number: 99-C-0125

Title:

Osteosarcoma: Outcome of Therapy Based on Histologic Response: A Collaborative Effort of the POB/NCI, Texas Children's Hospital and University of Oklahoma

Number:

99-C-0125

Summary:

This study will evaluate the safety and effectiveness of chemotherapy using the drugs doxorubicin, cisplatin, and methotrexate along with surgery to treat patients with bone cancer. Patients undergo chemotherapy followed by surgery to remove the tumor and then receive another course of chemotherapy

Patients =25 years old and diagnosed with osteosarcoma may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, MUGA (nuclear medicine test of heart function) or echocardiogram, computed tomography (CT) magnetic resonance imaging (MRI), bone scans, chest x-ray and , a hearing test.

Participants have a catheter (plastic tube) placed in a vein through which they receive treatment with chemotherapy, other medicines, intravenous fluids, and blood, if needed. Blood samples can be withdrawn through the catheter. Chemotherapy consists of doxorubicin, cisplatin and methotrexate given over 9 weeks. In addition, patients receive a drug called dexrazoxane before each dose of doxorubicin to protect the heart from possible injury due to doxorubicin, and they receive leucovorin after methotrexate to protect healthy cells from potential side effects of that drug.

When first screened and after 9 weeks of chemotherapy, patients have a type of MRI called dynamic enhanced magnetic resonance imaging (DEMRI). In addition to showing the bone and muscle, DEMRI provides information on blood flow in the area affected by the tumor. MRI takes about 35 minutes to complete, and the DEMRI portion of the imaging may take an additional 15 to 60 minutes. DEMRI may be done in conjunction with or separately from conventional MRI.

After the first 10 weeks of chemotherapy, patients are referred for surgery to remove the primary tumor and any other tumor tissue that may have spread to other sites. Portions of the tumor may be used for research tests.

The removed tumor is examined to determine the amount of tumor that has survived, and patients then receive more courses of doxorubicin with dexrazoxane, cisplatin and methotrexate.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Pediatric

PBSCT

Doxorubicin

Cisplatin

Melphalan

Recruitment Keyword(s):

Osteosarcoma

Condition(s):

Osteosarcoma

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Drug: Doxorubicin

Drug: Cisplatin

Drug: Melphalan

Drug: Cyclophosphamide

Drug: 2-Fluoro-2-Deoxyglucose

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Loss of heterozygosity of RB gene is a poor prognostic factor in patients with osteosarcoma

Pediatric osteosarcoma: therapeutic strategies, results, and prognostic factors derived from a 10-year experience

Primary osteogenic sarcoma: pathologic aspects in 20 patients after treatment with chemotherapy, en bloc resection and prosthetic bone replacement

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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