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:

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility 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.

Special Instructions: Currently Not Provided

Keywords:

Pediatric

PBSCT

Doxorubicin

Cisplatin

Melphalan

Recruitment Keywords:

Osteosarcoma

Conditions:

Osteosarcoma

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239

Electronic Address: ncicssc@mail.nih.gov

Citations:

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

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