Status:
TERMINATED
A Study of Pre-Operative Treatment of Newly-Diagnosed, Surgically-Resectable Osteosarcoma With Doxorubicin, Ifosfamide, Etoposide, and Cisplatin With Early Metabolic Assessment of Response
Lead Sponsor:
University of Chicago
Conditions:
Osteosarcoma
Lung Metastases
Eligibility:
All Genders
2-35 years
Phase:
PHASE1
Brief Summary
This is a pilot study that will allow investigators to collect data related to early and potentially more accurate response assessments using a chemotherapy protocol that eliminates methotrexate to ma...
Eligibility Criteria
Inclusion
- Must be between 2 and 35 years of age at time of diagnosis
- Must have biopsy-proven, high-grade osteosarcoma.
- Patients with metastases are eligible as long as the lung is the only site of metastatic disease.
- The primary tumor and all pulmonary metastases must be deemed to be potentially resectable. There must be a commitment by the surgical team to resect the primary tumor at week 12, and pulmonary nodules at any point, unless the clinical situation indicates these interventions are not in the patient's best interest.
- Patients must have normal laboratory values and cardiac function as defined below:
- Creatinine clearance or radioisotope GFR of \> or equal to 70ml/min/1.73 m2 OR
- A serum creatinine based on age/gender as follows:
- Age Maximum Serum Creatinine (mg/dL) Male Female
- 1 month to \< 6 months 0.4 0.4 6 months to \< 1 year 0.5 0.5
- to \< 2 years 0.6 0.6
- to \< 6 years 0.8 0.8
- 6 to \< 10 years 1 1 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4
- or equal to 16 years 1.7 1.4
- Cardiac: Adequate cardiac function is defined as:
- Shortening fraction of \> or equal to 28% by echocardiogram OR Ejection fraction of \> or equal to 50% by radionuclide angiogram
- Hepatic: Adequate liver function is described as:
- Total bilirubin of \< or equal to 1.5 x upper limit of normal (ULN) for age
- Hematologic function: adequate hematologic function is defined as:
- ANC \> or equal to 1.5 x 10\^9/L and platelet count \> or equal to 100 x 10\^9/L
- Female patients must have a negative pregnancy test
- Female patients who are lactating must agree to stop breast-feeding.
- Patients must not be known to be HIV positive. Testing for HIV is not mandatory.
- Sexually active patients of childbearing potential must agree to use effective contraception.
- Patients must be able to cooperate fully with all planned protocol therapy.
- Signed informed consent MUST be obtained from patient or parent/legal guardian prior to any study procedures and study entry.
Exclusion
- Patients with any low-grade osteosarcoma, post-radiation osteosarcoma, and osteosarcoma associated with Paget's disease are not eligible.
- Patients with metastases other than lung metastases are not eligible.
- Patients may not have received prior chemotherapy.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01258634
Start Date
July 1 2010
End Date
November 1 2011
Last Update
December 10 2013
Active Locations (1)
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1
University of Chicago Department of Pediatrics Hematology/Oncology
Chicago, Illinois, United States, 60637