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Study Summary
No. 2007-0404:.......Advanced Cancers; Bone; Pediatrics; Sarcoma......Peter M. Anderson......Pediatrics
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Study Summary Title
Study Summary
Number:		2007-0404
Study Title:Outpatient Chemotherapy in Pediatric Osteosarcoma: Doxorubicin with Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy
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Physician New Patient Referral
Name:Peter M. AndersonPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:PediatricsReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-0893
Contact us about clinical trials
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General Information
Disease Group:Advanced Cancers
Bone
Pediatrics
Sarcoma		Supported By:N/A
Phase of Study:N/AReturn
Visit:		During chemotherapy administration: daily. After chemotherapy infusions
completed, every 2-3 weeks (i.e. until counts recovered to begin next cycle).
Treatment
Agents:		Cisplatin
Dexrazoxane
Doxorubicin
Ifosfamide
Leucovorin
Liposomal MTP-PE
Mesna
Methotrexate		Home Care:Continuous infusion chemotherapy (ifosfamide/mesna , cisplatin) and iv fluids +
oral leucovorin. Patients will have daily clinic checks during home therapy.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		5-7 days for intrarterial infusion, 3 or 5 times, every 2-3 weeks
Description/
Intervention:		The goal of this clinical research study is to learn if giving certain
combinations of chemotherapy drugs before and after surgery, mostly in the
outpatient clinic instead of in the hospital, can result in fewer hospital
stays during treatment for osteosarcoma. The drugs and schedules will vary
depending on the status of the cancer and its level of risk for spreading, but
they will include combinations of doxorubicin (non-liposomal), cisplatin,
methotrexate, and ifosfamide, as described below.
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Study Objectives / Outcomes
Primary Objectives:
Develop an outpatient thoracic treatment paradigm by reducing the number of hospitalizations during front-line osteosarcoma therapy and to improve Quality of Life (QOL) and quality of care by providing state-of the art osteosarcoma treatment in the pediatric outpatient clinic (e.g. Pediatric Ambulatory Therapy Center, PATC) except for intra-arterial chemotherapy, surgery, significant illness, or if requested by the patient and/or caregiver.

Secondary Objectives:
    1. To document incidence of lung metastases on therapy and after completion of therapy.
    2. Monitor safety profile and determine efficacy (PFS) of a lung-directed therapy in higher-risk patients using L-MTP-PE.
    3. Collect data on local control including: type of procedure(s) for control of primary tumor, type of procedure(s) for control of metastases, time interval from start of chemotherapy to achieve no evidence of disease (NED) status, wound complications and infections, and percent necrosis of surgical specimens.
    4. Compare PFS for non-metastatic extremity (standard-risk) and higher-risk cohorts.
    5. Analyze FAS expression on surgical specimens (lung metastases and primary tumors)
    6. Monitor incidence of ototoxicity (>40 dB loss at 4000 Hz and/or >30dB at 2000Hz) and cardiotoxicity (EF decrease>10 % or <50% EF).
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:12/04/2007
Study Type:Other
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Newly diagnosed high-grade osteosarcoma. Patients with unresectable or metastatic disease ARE eligible.

2) Age 5-40 years old on date of diagnostic biopsy.

3) Adequate organ function: creatinine 1.6 or lower, bilirubin <2, Hemoglobin 8 gm/dL or greater, ANC 1000 or more, platelets 100,000 or more. Cardiac EF 50% or better, hearing threshold 40 dB at 4000 Hz or better.

4) Signed informed consent.

5) Negative pregnancy test in females of child bearing potential, and if sexually active, willingness to use effective contraception during chemotherapy.
Exclusion Criteria:1) Diagnosis other than osteosarcoma.

2) Pregnant or lactating females, or unwilling to use effective contraception during chemotherapy
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Links
Registration Number: NCT00673179
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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