Combination Chemotherapy, Radiation Therapy, and Sargramostim Before and After Surgery in Treating Patients With Soft Tissue Sarcoma That Can Be Removed By Surgery

• Status: Completed
• Trial end date: 1969-12-31
• 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. GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing. GM-CSF, given by inhalation, may interfere with the growth of tumor cells and prevent metastases from forming. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy and GM-CSF before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy and GM-CSF before and after surgery works in treating patients with stage III soft tissue sarcoma that can be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Ifosfamide; Liposomal doxorubicin; Mitomycin; Mitomycins; Molgramostim; Sargramostim

Criteria

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