Status:
COMPLETED
Combination Chemotherapy in Treating Patients With Sarcoma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Sarcoma
Eligibility:
All Genders
Up to 21 years
Phase:
EARLY_PHASE1
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 ch...
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 smal...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 1991
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00662233
Start Date
October 1 1991
End Date
October 21 2013
Last Update
October 9 2018
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905