Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-04-15 @ 2:11 AM
Study NCT ID:
NCT00652860
Status:
COMPLETED
Last Update Posted:
2011-05-16
First Post:
2008-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy, Radiation Therapy, and Sargramostim Before and After Surgery in Treating Patients With Soft Tissue Sarcoma That Can Be Removed By Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081222', 'term': 'sargramostim'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D016685', 'term': 'Mitomycin'}, {'id': 'D005434', 'term': 'Flow Cytometry'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D050486', 'term': 'Serotonin Plasma Membrane Transport Proteins'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D027981', 'term': 'Symporters'}, {'id': 'D016623', 'term': 'Ion Pumps'}, {'id': 'D026901', 'term': 'Membrane Transport Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D050480', 'term': 'Plasma Membrane Neurotransmitter Transport Proteins'}, {'id': 'D050479', 'term': 'Neurotransmitter Transport Proteins'}, {'id': 'D000070590', 'term': 'Solute Carrier Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'lastUpdateSubmitDate': '2011-05-13', 'studyFirstSubmitDate': '2008-04-03', 'studyFirstSubmitQcDate': '2008-04-03', 'lastUpdatePostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary metastatic progression-free rate at 2 years'}], 'secondaryOutcomes': [{'measure': 'Survival'}, {'measure': 'Time to progression'}, {'measure': 'Toxicity as per NCI CTC Version 2.0'}, {'measure': 'Tumor response every 4 weeks during treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lung metastases', 'stage III adult soft tissue sarcoma'], 'conditions': ['Metastatic Cancer', 'Sarcoma']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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 GM-CSF, plus irradiation with concomitant MAP followed by post-operative aerosol GM-CSF.\n\nSecondary\n\n* To evaluate survival of these patients.\n* To evaluate time to progression in these patients.\n* To evaluate toxicity in these patients.\n* To evaluate tumor response in these patients.\n\nTranslational\n\n* To observe and describe sequentially before treatment, after treatment, and after recovery from treatment the frequency of skin test anergy and cellular immunity in extremity soft tissue sarcoma receiving systemic GM-CSF preoperatively and aerosol GM-CSF as part of both preoperative and postoperative treatment.\n\nOUTLINE:\n\n* Neoadjuvant treatment: Patients receive ifosfamide IV over 2 hours on days 0 and 1 and cisplatin IV over 4 hours, mitomycin IV and doxorubicin IV on day 1. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) every 12 hours on days -6 to -3, 2-14, and 22-25. Beginning on day 84 patients also undergo radiotherapy once daily, five days a week, continuing for five weeks. Patients also receive GM-CSF SC twice daily on days -3 and 2 -15 and aerosol GM-CSF twice daily on days 85 - 91, 99 -105, and 113 - 119.\n* Chemoradiotherapy: Beginning 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radiotherapy (RT) once daily, 5 days a week, for 5 weeks. Patients also receive aerosolized GM-CSF twice daily on days 2-8, 16-22, and 30-38 and mitomycin C IV, doxorubicin hydrochloride IV, and cisplatin IV over 2 hours on days 1 and 29.\n* Surgery: Four weeks after completion of chemotherapy, patients undergo surgery. Patients may also undergo intraoperative RT electron boost or intraoperative high-dose brachytherapy.\n* Adjuvant treatment: Beginning 4 weeks after surgery, patients receive aerosol GM-CSF twice daily on days -7, 15-21, 35-42, 56-63, and 77-84. Some patients may undergo external beam RT 2-4 weeks after surgery.\n\nBlood samples are collected at baseline and at 4 and 14 weeks after surgery. Samples are tested for NY-ESO-1 by staining, for T-cell subset by flow cytometry, and for autologous lymphocyte proliferation. Patients may also be tested for delayed-type hypersensitivity and skin test anergy.\n\nAfter completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and at 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary soft tissue sarcoma\n\n * Sarcoma must be of the extremity or limb girdle origin\n * No metastatic disease\n * High-grade\n* Must be a candidate for preoperative irradiation for potential limb-sparing surgery\n* Must not have any of the following:\n\n * Embryonal rhabdomyosarcoma\n * Extraosseous Ewing sarcomas\n\nPATIENT CHARACTERISTICS:\n\nInclusion criteria:\n\n* ECOG performance status 0 - 2\n* WBC ≥ 3,500/μL OR granulocyte count ≥1,500/μL\n* Platelets ≥150,000/μL\n* Direct-reacting bilirubin ≤ 0.3 mg/dL\n* Creatinine ≤1.2 times the upper limit of normal\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nExclusion criteria:\n\n* Significant infection\n* Active heart disease including any of the following:\n\n * Myocardial infarction in the past 3 months\n * Symptomatic coronary artery insufficiency\n * First-degree heart block\n * Clinical history of congestive heart failure\n* Symptomatic pulmonary disease.\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy or radiotherapy for cancer'}, 'identificationModule': {'nctId': 'NCT00652860', 'briefTitle': 'Combination Chemotherapy, Radiation Therapy, and Sargramostim Before and After Surgery in Treating Patients With Soft Tissue Sarcoma That Can Be Removed By Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Chemotherapy, Irradiation, and Surgery for Function-Preserving Curative Therapy of Primary Extremity Soft Tissue Sarcomas: Initial Treatment With I-MAP and GM-CSF; Aerosol GM-CSF During Preoperative Irradiation and Postoperatively', 'orgStudyIdInfo': {'id': 'CDR0000582297'}, 'secondaryIdInfos': [{'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}, {'id': 'MC0072', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}, {'id': '1021-01', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'aerosol sargramostim', 'type': 'BIOLOGICAL'}, {'name': 'sargramostim', 'type': 'BIOLOGICAL'}, {'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG'}, {'name': 'ifosfamide', 'type': 'DRUG'}, {'name': 'mitomycin C', 'type': 'DRUG'}, {'name': 'flow cytometry', 'type': 'OTHER'}, {'name': 'immunological diagnostic method', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'multimodality therapy', 'type': 'PROCEDURE'}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE'}, {'name': 'intraoperative radiation therapy', 'type': 'RADIATION'}, {'name': 'selective external radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Scott Okuno, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Scott Okuno, M.D.', 'oldOrganization': 'Mayo Clinic'}}}}