Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT00023634
Status:
TERMINATED
Last Update Posted:
2015-03-06
First Post:
2001-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D001254', 'term': 'Astrocytoma'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081222', 'term': 'sargramostim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'lack of accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2001-09-13', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'toxicity', 'timeFrame': 'during treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage II gastric cancer', 'stage III gastric cancer', 'stage IV gastric cancer', 'recurrent gastric cancer', 'adenocarcinoma of the prostate', 'stage II ovarian epithelial cancer', 'stage III ovarian epithelial cancer', 'stage IV ovarian epithelial cancer', 'recurrent adult brain tumor', 'stage IV prostate cancer', 'recurrent prostate cancer', 'adult anaplastic astrocytoma'], 'conditions': ['Brain Tumors', 'Gastric Cancer', 'Ovarian Cancer', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill cancer cells.\n\nPURPOSE: This phase I trial is studying two different vaccines to treat patients who have gastric, prostate, or ovarian cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the toxicity of EGFRvIII peptide vaccine with sargramostim (GM-CSF) or keyhole limpet hemocyanin (KLH) as adjuvant in patients with EGFRvIII-expressing cancer.\n* Determine the preexisting antibody and T-cell responses to EGFRvIII in these patients.\n* Determine the antibody and T-cell responses to EGFRvIII peptide after immunization with this vaccine with GM-CSF or KLH as adjuvant.\n\nOUTLINE: Patients are assigned to one of two treatment arms.\n\n* Arm I: Patients receive a vaccine containing EGFRvIII peptide admixed with sargramostim (GM-CSF) intradermally monthly.\n* Arm II: Patients receive a vaccine containing EGFRvIII peptide admixed with keyhole limpet hemocyanin subcutaneously monthly.\n\nTreatment in both arms continues for 6 months in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 1 year.\n\nPROJECTED ACCRUAL: A total of 24 patients (12 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed diagnosis of one the following:\n\n * Stage II-IV gastric cancer\n * Stage IIC-IV ovarian cancer in first complete remission\n\n * CA 125 normal and stable\\*\n * Grade III anaplastic astrocytoma\n * Stage IV (M1) prostate adenocarcinoma\n\n * No small cell variations\n * No biochemical progression after definitive surgery, defined by the following:\n\n * Prostate-specific antigen more than 0.4 ng/mL which remains elevated on 2 additional measurements at least 2 weeks apart after prostatectomy\n * Three consecutive rises in PSA, each at least 1 month apart after definitive radiotherapy\n * Must be receiving androgen blockade\n * PSA less than 5 ng/mL and stable\\*\n* Documented EGFRvIII expression in primary tumor\n* Must have received prior surgery and or chemoradiotherapy for disease (except prostate cancer patients) NOTE: \\*Stable defined as no increase over 2 measurements at least 28 days apart with the last measurement within the past 28 days\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 80 and under\n\nPerformance status:\n\n* Zubrod 0\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 3,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 10 g/dL\n\nHepatic:\n\n* SGOT no greater than 2.5 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 2.5 times ULN\n* No hepatitis\n\nRenal:\n\n* Not specified\n\nOther:\n\n* No other malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission\n* No contraindication to receiving sargramostim (GM-CSF) or KLH-based vaccine products\n* No autoimmune disease\n* HIV negative\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 1 month since prior cytotoxic chemotherapy\n* No concurrent chemotherapy\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* At least 1 month since prior treatment dose corticosteroids\n* No concurrent corticosteroids\n\nRadiotherapy:\n\n* See Disease Characteristics\n* No concurrent radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* Recovered from all prior therapies\n* No concurrent enrollment on other phase I studies\n* No other concurrent immune modulators'}, 'identificationModule': {'nctId': 'NCT00023634', 'briefTitle': 'S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers', 'orgStudyIdInfo': {'id': 'S0114'}, 'secondaryIdInfos': [{'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}, {'id': 'R01CA082661', 'link': 'https://reporter.nih.gov/quickSearch/R01CA082661', 'type': 'NIH'}, {'id': 'S0114', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'UW-106', 'type': 'OTHER', 'domain': 'University of Washington'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EGFR vaccine with GMCSF', 'description': 'EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m', 'interventionNames': ['Biological: GMCSF']}, {'type': 'EXPERIMENTAL', 'label': 'EGFR vaccine with KLH', 'description': 'EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m', 'interventionNames': ['Biological: KLH']}], 'interventions': [{'name': 'KLH', 'type': 'BIOLOGICAL', 'otherNames': ['keyhole limpet'], 'description': '100 mcg w/EGFRvIII', 'armGroupLabels': ['EGFR vaccine with KLH']}, {'name': 'GMCSF', 'type': 'BIOLOGICAL', 'otherNames': ['sargramostim'], 'description': 'arm 1: 100 mcg w/EGFRvIII', 'armGroupLabels': ['EGFR vaccine with GMCSF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48708', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bay Regional Medical Center', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '48060', 'city': 'Port Huron', 'state': 'Michigan', 'country': 'United States', 'facility': 'Mercy Regional Cancer Center at Mercy Hospital', 'geoPoint': {'lat': 42.97086, 'lon': -82.42491}}, {'zip': '98225', 'city': 'Bellingham', 'state': 'Washington', 'country': 'United States', 'facility': 'St. Joseph Hospital Community Cancer Center', 'geoPoint': {'lat': 48.75955, 'lon': -122.48822}}, {'zip': '98310', 'city': 'Bremerton', 'state': 'Washington', 'country': 'United States', 'facility': 'Olympic Hematology and Oncology', 'geoPoint': {'lat': 47.56732, 'lon': -122.63264}}, {'zip': '98273', 'city': 'Mount Vernon', 'state': 'Washington', 'country': 'United States', 'facility': 'Skagit Valley Hospital Cancer Care Center', 'geoPoint': {'lat': 48.42122, 'lon': -122.33405}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98112', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Group Health Central Hospital', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98114', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute at Swedish Medical Center - First Hill Campus', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195-6043', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University Cancer Center at University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98284', 'city': 'Sedro-Woolley', 'state': 'Washington', 'country': 'United States', 'facility': 'North Puget Oncology at United General Hospital', 'geoPoint': {'lat': 48.50389, 'lon': -122.23611}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Cancer Care Northwest - Spokane South', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98801', 'city': 'Wenatchee', 'state': 'Washington', 'country': 'United States', 'facility': 'Wenatchee Valley Clinic', 'geoPoint': {'lat': 47.42346, 'lon': -120.31035}}], 'overallOfficials': [{'name': 'Robert B. Montgomery, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'VA Puget Sound Health Care System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}