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

NCT00652860 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000582297P30CA015083MC00721021-01
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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 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

Keywords

lung metastases; stage III adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

• Pulmonary metastatic progression-free rate at 2 years

Secondary Outcomes (4)

• Survival

• Time to progression

• Toxicity as per NCI CTC Version 2.0

• Tumor response every 4 weeks during treatment

Interventions

aerosol sargramostim BIOLOGICAL

sargramostim BIOLOGICAL

cisplatin DRUG

doxorubicin hydrochloride DRUG

ifosfamide DRUG

mitomycin C DRUG

flow cytometry OTHER

immunological diagnostic method OTHER

laboratory biomarker analysis OTHER

adjuvant therapy PROCEDURE

multimodality therapy PROCEDURE

neoadjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

intraoperative radiation therapy RADIATION

selective external radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Neoplasm Metastasis; Sarcoma

Interventions

sargramostim; Cisplatin; Doxorubicin; Ifosfamide; Mitomycin; Flow Cytometry; Chemotherapy, Adjuvant; Combined Modality Therapy; Neoadjuvant Therapy; Serotonin Plasma Membrane Transport Proteins

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Mitomycins; Indolequinones; Quinones; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Therapeutics; Drug Therapy; Symporters; Ion Pumps; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plasma Membrane Neurotransmitter Transport Proteins; Neurotransmitter Transport Proteins; Solute Carrier Proteins; Membrane Proteins

Study Officials

• Scott Okuno, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 4, 2008
• Study Start: August 1, 2001
• Primary Completion: November 1, 2006
• Last Updated: May 16, 2011

Record last verified: 2011-05