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Combination Chemotherapy in Treating Patients With Sarcoma

A Pilot Study for Soft Tissue Sarcoma

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00662233
Enrollment
28
Registered
2008-04-21
Start date
1991-10-31
Completion date
2013-10-21
Last updated
2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGcyclophosphamide
DRUGdoxorubicin hydrochloride
DRUGetoposide
DRUGifosfamide
DRUGvincristine sulfate
PROCEDUREadjuvant therapy
PROCEDUREneoadjuvant therapy
PROCEDUREtherapeutic conventional surgery
RADIATIONbrachytherapy
RADIATIONradiation therapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Efficacy in terms of long-term disease-free survival
Clinical response of the tumors
Pathologic response of the tumors
Long term disease-free survival

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026