Combination Chemotherapy in Treating Patients With Sarcoma
Primary Purpose
Ovarian Cancer, Sarcoma
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
cyclophosphamide
doxorubicin hydrochloride
etoposide
ifosfamide
vincristine sulfate
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery
brachytherapy
intraoperative radiation therapy
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring alveolar childhood rhabdomyosarcoma, previously treated childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma, nonmetastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, childhood desmoplastic small round cell tumor, ovarian sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, embryonal childhood rhabdomyosarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of any of the following:
- High-grade nonmetastatic, nonrhabdomyosarcomatous soft tissue sarcomas (excluding undifferentiated sarcoma and Ewing sarcoma)
- Small round cell sarcomas (excluding primitive neuroectodermal tumors of soft tissue) (closed to accrual)
- Undifferentiated sarcomas (closed to accrual)
- Rhabdomyosarcomas (excluding non-parameningeal head tumors, vaginal or stage I paratesticular) (closed to accrual)
- All alveolar rhabdomyosarcomas (closed to accrual)
No evidence distant metastatic disease (i.e., lung, bone, bone marrow)
- Local or regional nodal disease allowed
- No spindle cell tumors of bone
- Primary lesions do not have to be resectable
PATIENT CHARACTERISTICS:
- Creatinine ≤1.5 mg/dL OR creatinine clearance > 60 mL/min/
- AST/ALT < 2 times upper limit of normal (ULN)
- Total bilirubin < 2 times ULN
- LVEF ≥ 45%
- No prior history of cancer
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- Patients who have undergone radiation therapy after initial surgery are eligible but must have evaluation for metastatic disease within 2 weeks of starting chemotherapy
- No prior chemotherapy
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
Efficacy in terms of long-term disease-free survival
Clinical response of the tumors
Pathologic response of the tumors
Long term disease-free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00662233
First Posted
April 18, 2008
Last Updated
October 4, 2018
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00662233
Brief Title
Combination Chemotherapy in Treating Patients With Sarcoma
Official Title
A Pilot Study for Soft Tissue Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 1991 (Actual)
Primary Completion Date
October 21, 2013 (Actual)
Study Completion Date
October 21, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients with sarcoma.
Detailed Description
OBJECTIVES:
To evaluate the efficacy, in terms of clinical response, pathologic response, and long-term disease-free survival, of a multidrug chemotherapy regimen patients with spindle cell or small round cell sarcoma.
OUTLINE: This is a multicenter study.
Induction therapy: Patients receive vincristine IV, cyclophosphamide IV over 1 hour and doxorubicin hydrochloride IV over 48 hours on day 1 in week 0. Patients continue to receive vincristine IV once weekly in weeks 1 and 2. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 3. Treatment repeats every 6 weeks for 2 courses.
Local control: After completing induction therapy, patients are reevaluated for local control therapy. Some patients may undergo surgery and/or radiotherapy (e.g., brachytherapy, intraoperative radiotherapy, external beam therapy). Patients who undergo surgery begin consolidation therapy 2 weeks after completing surgery. Some patients undergo radiotherapy 5 days a week for 5½ weeks beginning at week 12 and/or after surgery (weeks 15-16).
Consolidation therapy: Patients receive vincristine IV, doxorubicin hydrochloride IV over 1 hour, and cyclophosphamide IV over 1 hour once in weeks 12 and 18*. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 15. Patients are reevaluated for local control therapy at week 21.
NOTE: *Patients undergoing radiotherapy do not receive doxorubicin hydrochloride in week 18 or week 24.
Maintenance therapy: Patient receive vincristine IV, doxorubicin hydrochloride IV over 1 hour, and cyclophosphamide IV over 1 hour once in week 24. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 21. Treatment repeats every 6 weeks for 3 courses. In week 36, patients receive vincristine, doxorubicin hydrochloride and cyclophosphamide OR etoposide and ifosfamide as before. In week 39 patients receive etoposide and ifosfamide as before.
After completion of treatment, patients are followed periodically for at least 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Sarcoma
Keywords
alveolar childhood rhabdomyosarcoma, previously treated childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma, nonmetastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, childhood desmoplastic small round cell tumor, ovarian sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, embryonal childhood rhabdomyosarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
intraoperative radiation therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Efficacy in terms of long-term disease-free survival
Title
Clinical response of the tumors
Title
Pathologic response of the tumors
Title
Long term disease-free survival
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of any of the following:
High-grade nonmetastatic, nonrhabdomyosarcomatous soft tissue sarcomas (excluding undifferentiated sarcoma and Ewing sarcoma)
Small round cell sarcomas (excluding primitive neuroectodermal tumors of soft tissue) (closed to accrual)
Undifferentiated sarcomas (closed to accrual)
Rhabdomyosarcomas (excluding non-parameningeal head tumors, vaginal or stage I paratesticular) (closed to accrual)
All alveolar rhabdomyosarcomas (closed to accrual)
No evidence distant metastatic disease (i.e., lung, bone, bone marrow)
Local or regional nodal disease allowed
No spindle cell tumors of bone
Primary lesions do not have to be resectable
PATIENT CHARACTERISTICS:
Creatinine ≤1.5 mg/dL OR creatinine clearance > 60 mL/min/
AST/ALT < 2 times upper limit of normal (ULN)
Total bilirubin < 2 times ULN
LVEF ≥ 45%
No prior history of cancer
Not pregnant or nursing
Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Patients who have undergone radiation therapy after initial surgery are eligible but must have evaluation for metastatic disease within 2 weeks of starting chemotherapy
No prior chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carola A. S. Arndt, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combination Chemotherapy in Treating Patients With Sarcoma
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