Status:
COMPLETED
Combination Chemotherapy, Radiation Therapy, and Sargramostim Before and After Surgery in Treating Patients With Soft Tissue Sarcoma That Can Be Removed By Surgery
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Cancer
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. GM-CSF may stimulate the immune system in...
Detailed Description
OBJECTIVES: Primary * To evaluate 2-year pulmonary metastatic progression rates in patients with primary high-grade extremity soft tissue sarcoma who have received preoperative I-MAP, plus aerosol G...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary soft tissue sarcoma
- Sarcoma must be of the extremity or limb girdle origin
- No metastatic disease
- High-grade
- Must be a candidate for preoperative irradiation for potential limb-sparing surgery
- Must not have any of the following:
- Embryonal rhabdomyosarcoma
- Extraosseous Ewing sarcomas
- PATIENT CHARACTERISTICS:
- Inclusion criteria:
- ECOG performance status 0 - 2
- WBC ≥ 3,500/μL OR granulocyte count ≥1,500/μL
- Platelets ≥150,000/μL
- Direct-reacting bilirubin ≤ 0.3 mg/dL
- Creatinine ≤1.2 times the upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Exclusion criteria:
- Significant infection
- Active heart disease including any of the following:
- Myocardial infarction in the past 3 months
- Symptomatic coronary artery insufficiency
- First-degree heart block
- Clinical history of congestive heart failure
- Symptomatic pulmonary disease.
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for cancer
Exclusion
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00652860
Start Date
August 1 2001
Last Update
May 16 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.