Osteosarcoma Clinical Trial
Official title:
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
Verified date | December 2013 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 maximize the dose intensity of doxorubicin. The pilot data will be used to
seek funding to more fully address the hypotheses in a multi-institutional, Phase II or
Phase III trial. The primary and secondary objectives are as follows:
Primary:
1. To evaluate the feasibility and potential usefulness of measuring early changes in
tumor metabolic activity, assessed by Fludeoxyglucose-Positron Emission Tomography
(FDG-PET) imaging and alkaline phosphatase activity, as early predictors of
histological response rate at 12 weeks in osteosarcoma patients.
2. To explore whether histological response can be assessed by a computer algorithm using
virtual microscopic images of pathology material, and whether quantifying necrosis in
this way correlates with microscope slide-based review.
Secondary:
1. To gather pilot data on the histological response rate, 3-year event-free survival, and
toxicity when children and young adults with resectable osteosarcoma are treated using a
chemotherapy regimen of alternating courses of doxorubicin/cisplatin (DC) and
doxorubicin/ifosfamide/etoposide (IDE).
All patients will receive 4 courses of preoperative chemotherapy courses. With the exception
of high-dose methotrexate, which is given weekly, preoperative and postoperative
chemotherapy courses are planned to begin every 21 days.
Patients with good histological response (those patients with > 90% tumor necrosis at time
of definitive resection) will receive three postoperative chemotherapy courses. The 1st will
consist of doxorubicin, dexrazoxane, cisplatin and Granulocyte-Colony Stimulating Factor
(G-CSF)(or Polyethylene Glycol filgrastim). The 2nd course will consist of doxorubicin,
dexrazoxane, ifosfamide, MESNA, etoposide, G-CSF (or PEG-filgrastim). The 3rd course will
consist of ifosfamide, MESNA, etoposide, G-CSF (or PEG-filgrastrim). The total doxorubicin
dose will be 450 mg/m2.
Patients with poor response (those patients with < 90% tumor necrosis found on pathology at
time of definitive resection) will receive five postoperative chemotherapy courses. High
Dose-Methotrexate will be administered during the 1st and 3rd postoperative chemotherapy
courses as 4-weekly and 2-weekly doses, respectively. The 2nd course will consist of
doxorubicin, dexrazoxane, cisplatin and G-CSF (or PEG-filgrastim). The 4th course will
consist of doxorubicin, dexrazoxane, ifosfamide, Mesna, etoposide, G-CSF (or
PEG-filgrastim). The 5th cycle will consist of ifosfamide, Mesna, etoposide, G-CSF (or
PEG-filgrastrim). The total doxorubicin dose will be 450 mg/m2.
Status | Terminated |
Enrollment | 2 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 35 Years |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago Department of Pediatrics Hematology/Oncology | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility and usefulness of measuring early changes in tumor metabolic activity. | 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. | 6 months after last subject has been enrolled | No |
Secondary | Gather pilot data on the histological response rate | To gather pilot data on the histological response rate when children and young adults with resectable osteosarcoma are treated using a chemotherapy regimen of alternating courses of doxorubicin/cisplatin (DC) and doxorubicin/ifosfamide/etoposide (IDE). | 3 years after last enrolled subject has completed therapy | Yes |
Secondary | Explore whether histological response can be measured by a computer algorithm | To explore whether histological response can be measured by a computer algorithm using virtual microscopic images of pathology material, and whether quantifying necrosis in this way correlates with microscope slide-based review. | 1 year after last enrolled subject has completed therapy | No |
Secondary | Gather pilot data on 3-year event-free survival | To gather pilot data on the 3-year event-free survival when children and young adults with resectable osteosarcoma are treated using a chemotherapy regimen of alternating courses of doxorubicin/cisplatin (DC) and doxorubicin/ifosfamide/etoposide (IDE). | 3 years after last subject is enrolled | No |
Secondary | Gather pilot data on toxicity | To gather pilot data on toxicity when children and young adults with resectable osteosarcoma are treated using a chemotherapy regimen of alternating courses of doxorubicin/cisplatin (DC) and doxorubicin/ifosfamide/etoposide (IDE). | 3 years after last subject is enrolled on the study. | Yes |
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