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Home > "B" Clinical Trials Conditions > Bone Cancer: Treatment Outcome Based on Tumor Response  Bone Cancer: Treatment Outcome Based on Tumor Response
Bone Cancer: Treatment Outcome Based on Tumor Response
For Condition: Osteosarcoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Standard treatment for patients with non-metastatic bone cancer (cancer that has not spread beyond the bone) includes chemotherapy, then surgery to remove the tumor, and then another course of chemotherapy. Sixty to 70 percent of patients do well with this treatment. However, some of the drugs are highly toxic, causing serious side effects, and still, 30 to 40% of patients' tumors do not respond. In this study, patients will be separated into two different courses of treatment to try to: 1) reduce treatment time, number of medicines, and adverse side effects in patients whose tumors are largely destroyed by the first round of chemotherapy, and 2) improve survival in patients whose tumors do respond well to standard treatment. All patients will receive three doses of the drugs doxorubicin and cisplatin three weeks apart before surgery. Patients whose disease is confined to the bone and whose tumor responds well to the first round of chemotherapy (more than 90% destroyed) will be given another three courses of the same drugs after the tumor is removed. Other patients will be given three courses of the drugs melphalan and cyclophosphamide after surgery. These are patients whose tumor: is confined to the bone but did not respond well to the chemotherapy administered before surgery; had spread beyond the bone at the time of diagnosis; and could not be removed surgically. All patients will have blood tests and imaging studies, including PET scans and DEMRI-a type of magnetic resonance imaging-to evaluate their tumors before and during the study. Patients who receive melphalan and cyclophosphamide will also undergo a procedure to collect special cells called stem cells. These drugs destroy certain blood cells that fight infection and stop bleeding, and stem cells help the bone marrow replace them more quickly.
Details: Patients with non-metastatic osteosarcoma of the extremity have a 60-70% long-term survival with current therapy which includes neoadjuvant chemotherapy, surgical resection, and adjuvant combination chemotherapy. Response to neoadjuvant chemotherapy as measured histologically (% tumor necrosis) at the time of resection is a strong predictor of long-term outcome. Neoadjuvant regimens have typically included 2 or more of the following: doxorubicin, cisplatin, high-dose methotrexate and ifosfamide. In this collaborative pilot study between Texas Children's Hospital, the Pediatric Oncology Branch/NCI and University of Oklahoma Health Sciences Center, we propose to administer cisplatin, methotrexate, and doxorubicin with dexrazoxane for cardioprotection in the neoadjuvant setting. Patients with non-metastatic disease and good response (greater than or equal to 90% tumor necrosis) will receive additional courses of cisplatin/doxorubicmethotrexate in the post-surgical setting. Currently, three groups of patients with poor outcome can be identified: 1) metastatic disease at diagnosis 2) unresectable disease 3) non-metastatic disease with poor response to neoadjuvant chemotherapy (less than 90% tumor necrosis). For this subset of patients, we propose to intensify therapy with 3 courses of melphalan/cyclophosphamide in the adjuvant setting. Biologic studies including cDNA microarray analysis of tumor gene expression patterns and orthotopic implantation of tumor into SCID-Beige mice are planned in order to improve our understanding of the biology of osteosarcoma. Finally, Dynamic Magnetic Resonance Imaging (DEMRI) is proposed as a potential modality to be used in evaluating response to therapy.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: PART I Patients with histologically proven newly diagnosed osteosarcoma (patients with biopsy obtained at institutions other than NIH are eligible): Non-metastatic malignant high-grade osteosarcoma of bone. Patients with metastatic disease and/or unresectable primary disease are eligible. PART II Patients with recurrent and/or progressive disease during or after therapy based on other treatment protocols which did not include cyclophosphamide and/or melphalan will be eligible for the arm containing cyclophosphamide/melphalan with stem cell rescue. Age less than or equal to 25 years. Adequate bone marrow function with an ANC greater than or equal to 1000/mm(3), platelet count greater than or equal to 100,000 mm(3) and hemoglobin greater than or equal to 8.0 g/dl. Adequate renal function with serum creatinine less than or equal to 1.5 times normal and creatinine clearance or radioisotope GFR greater than 70 ml/min/1.73 m(2). Adequate cardiac function as determined by ECHO or MUGA (SF greater than or equal to 27% or EF greater than or equal to 45%). Adequate liver function (Total bilirubin less than or equal to 2.0 mg/dl; ALT less than 5 times normal). Informed Consent: All patients or their legal guardians (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 the study. EXCLUSION CRITERIA: Osteosarcoma secondary to radiation or that arising from premalignant conditions. Pregnancy. Low-grade osteosarcoma, parosteal or periosteal osteosarcoma. Patients who are currently receiving chemotherapy on other protocols or treatment plans with no evidence of progressive disease are not eligible for any part of this protocol.
Total Enrollment: 24
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 990125; 99-C-0125
Study Start Date: July 13, 1999
Record last reviewed: June 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001821
Other Osteosarcoma Studies:
1. Osteosarcoma Study #2: A Randomized Trial of Pre-Surgical Chemotherapy vs. Immediate Surgery and Adjuvant Chemotherapy in the Treatment of Non-Metastatic Osteosarcoma. A Pediatric Oncology Group Phase III Study
2. Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
3. Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
4. A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) with/without Tamoxifen in Patients with Osteosarcoma
5. Bone Cancer: Treatment Outcome Based on Tumor Response
Related Studies:
Other Osteosarcoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Bone Cancer: Treatment Outcome Based on Tumor Response
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