An interventional study of pegfilgrastim and doxorubicin hydrochloride in Sarcoma, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 2 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2022-12-15.
Sponsored by Masonic Cancer Center, University of Minnesota · Not applicable, Interventional, and Diagnostic
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) scan and computated tomography (CT) scan, may help doctors predict a patient's response to treatment and may help plan the best treatment. Drugs used in chemotherapy, such as doxorubicin and ifosfamide, 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.
PURPOSE: This clinical trial is studying how well PET scan combined with CT scan predicts response in patients undergoing chemotherapy and surgery for soft tissue sarcoma.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: Patients receive 1 of 2 standard chemotherapy regimens:
All patients undergo a fludeoxyglucose positron emission tomography/CT scan at baseline, after course 1, and after completion of chemotherapy. Patients undergo surgery within 4-6 weeks after completion of chemotherapy.
After completion of study treatment and surgery, patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 70 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must have histologically confirmed, high grade, soft tissue sarcoma including
NOTE: Ewings sarcoma, primitive neuroectodermal tumor, extraskeletal, osteosarcoma, extraskeletal chondrosarcoma, alveolar soft part sarcoma, rhabdomyosarcoma, carcinosarcoma, Kaposi's sarcoma, angiosarcoma, and mesothelioma patients are ineligible for this study.
Exclusion Criteria:
Patient must give written informed consent indicating the investigational nature of the study and its potential risks.
Subjects with soft tissue sarcoma who are receiving pegylated liposomal doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Biological: pegfilgrastim · Drug: ifosfamide · Drug: pegylated liposomal doxorubicin hydrochloride · Procedure: conventional surgery · Radiation: fludeoxyglucose F 18
Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Biological: pegfilgrastim · Drug: doxorubicin hydrochloride · Drug: ifosfamide · Procedure: conventional surgery · Radiation: fludeoxyglucose F 18
will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion
Also known as: Neulasta(R)
65 mg/m\^2 by continuous intravenous (IV) infusion over 7 days beginning on day 1
Also known as: Doxorubicin, Adriamycin
9 g/m\^2 by continuous intravenous (IV) infusion over 6 days beginning on day 1 with mesna 10.5 g/m\^2 by continuous IV infusion over 7 days beginning on day 1
Also known as: Mitoxana, Ifex
45 mg/m2 intravenous (IV) Day 1, repeat every 28 days.
Also known as: doxorubicin-hydrochloride-liposome
The surgical procedure will be decided by the treating physician and independent of study participation
FDG is a radioactive sugar equal to a uniform whole-body exposure of approximately 1.5 rem for each scan. Post-operative radiation therapy may be given according to institutional guidelines in patients felt to have close surgical margins.
Also known as: FDG
Disease-free survival
Compare changes in baseline and follow-up fludeoxyglucose (FDG) positron emission tomography (PET)/CT imaging with disease-free survival by peak SUV and max SUV calculations. Changes in baseline and follow-up PET/CT, based on max SUV calculations, will be compared with disease free survival. Disease free survival will be measured in months from the time of study enrollment until the time that disease recurrence/relapse/progression is recorded.
Time frame: Baseline through Survival Event
Correlate histologic response with FDG-PET/CT imaging
The overall histologic response will be defined as: % histologic response = 100 - % viable tumor in the central slice as assessed histologically It should be noted that the % histologic response is different from % tumor necrosis as it includes an assessment of the % tumor necrosis along with the degenerative changes
Time frame: At end of each cycle
Compare changes in FDG-PET/CT imaging with disease-free survival by max SUV calculations
Changes in PET/CT from baseline will be compared to PET/CT done after one cycle and after completion of chemotherapy treatment before surgical excision using max SUV calculations.
Time frame: Baseline Compared to 1 Cycle and Baseline to After Chemotherapy
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Masonic Cancer Center, University of Minnesota