Combination Chemotherapy in Treating Patients With Sarcoma

• Status: Completed
• Trial end date: 2013-10-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Doxorubicin; Etoposide; Ifosfamide; Liposomal doxorubicin; Vincristine

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