Combination Chemotherapy in Treating Patients Undergoing Surgery for Newly Diagnosed High-Grade Osteosarcoma

NCT ID: NCT00645632

Last Updated: 2011-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1990-11-30
• Study Completion Date: 2008-01-31

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ifosfamide, methotrexate, cisplatin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients undergoing surgery for newly diagnosed high-grade osteosarcoma.

Detailed Description

OBJECTIVES:

• To evaluate the efficacy of a new induction regimen comprising ifosfamide in combination with high-dose methotrexate, cisplatin, and doxorubicin hydrochloride, in terms of clinical response and pathological response of the tumor, in patients with newly diagnosed high-grade osteosarcoma.
• To determine the overall survival and disease-free survival of these patients.
• To evaluate the toxicity of this regimen.
• To correlate MRI imaging of the primary tumor with histopathologic grading after treatment with this regimen.

OUTLINE: This is a multicenter study.

• Neoadjuvant chemotherapy (weeks 1-15): Patients receive ifosfamide IV over 1 hour on days 1-5 and 36-40; doxorubicin hydrochloride IV over 18 hours on days 1-3 and 36-38 and IV over 72 hours on days 71-73; high-dose methotrexate IV over 4 hours on days 22, 29, 57, 64, 92, and 99; and cisplatin IV over 4 hours on day 71.
• Surgery (week 16): Patients undergo resection of the tumor on day 106. Patients found to have unresectable disease are treated on an alternative protocol unless they have clear clinical and pathologic response to treatment.
• Adjuvant chemotherapy (weeks 18-43): Beginning 2 weeks after surgery, patients receive ifosfamide IV over 1 hour on days 120-124, 155-159, 225-229, and 260-264; doxorubicin hydrochloride IV over 18 hours on days 120-122 and 155-157 and IV over 72 hours on days 190-192; high-dose methotrexate IV over 4 hours on days 141, 148, 176, 183, 211, 218, 246, 253, 281, and 288; and cisplatin IV over 4 hours on days 190 and 289.

After completion of study therapy, patients are followed every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Conditions

Sarcoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

ifosfamide

Intervention Type: DRUG

methotrexate

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy

• Patients with retinoblastoma may have received radiotherapy to the orbits
• At least 28 days since prior initial amputation

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Gerald S. Gilchrist, MD

Role: STUDY_CHAIR

Mayo Clinic

Tom R Fitch, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Gerardo Colon-Otero, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

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909101

Identifier Type: OTHER

Identifier Source: secondary_id

549-90

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000582263

Identifier Type: -

Identifier Source: org_study_id