NCT00662233CompletedPhase 1
A Pilot Study for Soft Tissue Sarcoma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Long term disease-free survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- — to 21 Years (Child, Adult)
- Sex
- All
- Accepts 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Long term disease-free survival
Clinical response of the tumors
Pathologic response of the tumors
Efficacy in terms of long-term disease-free survival
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Terminated
Phase 2
Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic CancerPancreatic CancerNCT01167738IRCCS San Raffaele60
Completed
Phase 3
Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon CancerColorectal CancerNCT00112918Hoffmann-La Roche3,451
Completed
Not Applicable
Chemotherapeutic Agents in Brain/BreastMetastatic CancerBreast CancerNCT00795678Case Comprehensive Cancer Center10
Completed
Phase 1
Chemotherapy in Treating Patients With Breast CancerBreast CancerNCT00012129NYU Langone Health
Completed
Phase 2
Combination Chemotherapy in Treating Children With LymphomaLymphomaNCT00002590Children's Oncology Group221