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A Pilot Study of Pre-Operative Treatment of Newly-Diagnosed, Surgically-Resectable Osteosarcoma With Doxorubicin, Ifosfamide, Etoposide, and Cisplatin With Early Metabolic Assessment of Response


Phase 0
2 Years
35 Years
Not Enrolling
Both
Osteosarcoma, Lung Metastases

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Trial Information

A Pilot Study of Pre-Operative Treatment of Newly-Diagnosed, Surgically-Resectable Osteosarcoma With Doxorubicin, Ifosfamide, Etoposide, and Cisplatin With Early Metabolic Assessment of Response


Inclusion Criteria:



- 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

1. to < 2 years 0.6 0.6

2. 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility and usefulness of measuring early changes in tumor metabolic activity.

Outcome Description:

The feasibility and potential usefulness of measuring early changes in tumor metabolic activity will be assessed by early Fludeoxyglucose-Positron Emission Tomography imaging and alkaline phosphatase activity.

Outcome Time Frame:

6 months after last subject has been enrolled

Safety Issue:

No

Principal Investigator

Stephen X. Skapek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Institutional Review Board

Study ID:

10-186-B

NCT ID:

NCT01258634

Start Date:

July 2010

Completion Date:

November 2011

Related Keywords:

  • Osteosarcoma
  • Lung Metastases
  • Osteosarcoma
  • Surgically Resectable High Grade Osteosarcoma
  • Lung Metastases Only
  • Neoplasm Metastasis
  • Osteosarcoma
  • Lung Neoplasms

Name

Location

University of Chicago Department of Pediatrics Hematology/OncologyChicago, Illinois  60637