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

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.

Conditions

• Metastatic Cancer
• Sarcoma

Interventions

BIOLOGICAL

aerosol sargramostim

BIOLOGICAL

sargramostim

DRUG

cisplatin

DRUG

doxorubicin hydrochloride

DRUG

ifosfamide

DRUG

mitomycin C

OTHER

flow cytometry

OTHER

immunological diagnostic method

OTHER

laboratory biomarker analysis

PROCEDURE

adjuvant therapy

PROCEDURE

multimodality therapy

PROCEDURE

neoadjuvant therapy

PROCEDURE

therapeutic conventional surgery

RADIATION

intraoperative radiation therapy

RADIATION

selective external radiation therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Scott Okuno, MD · Mayo Clinic

Study Design

Purpose

TREATMENT

Masking

NONE

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-08-31

Primary Completion

2006-11-30