Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-28 @ 11:24 PM
Study NCT ID:
NCT00005956
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2000-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Therapy in Treating Patients With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue 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': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2002-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2000-07-05', 'studyFirstSubmitQcDate': '2003-05-20', 'lastUpdatePostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '12 months', 'description': 'safety'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage II breast cancer', 'stage IV breast cancer', 'stage IIIA breast cancer', 'stage II gastric cancer', 'stage III gastric cancer', 'stage IV gastric cancer', 'stage IIIB breast cancer', 'stage III ovarian epithelial cancer', 'stage IV ovarian epithelial cancer'], 'conditions': ['Breast Cancer', 'Gastric Cancer', 'Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '17822557', 'type': 'RESULT', 'citation': 'Morse MA, Hobeika A, Osada T, Niedzwiecki D, Marcom PK, Blackwell KL, Anders C, Devi GR, Lyerly HK, Clay TM. Long term disease-free survival and T cell and antibody responses in women with high-risk Her2+ breast cancer following vaccination against Her2. J Transl Med. 2007 Sep 6;5:42. doi: 10.1186/1479-5876-5-42.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: A person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.\n\nPURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have advanced cancer that shows no signs of disease following treatment.", 'detailedDescription': 'OBJECTIVES:\n\n* Evaluate the immune response of patients with HER2/neu expressing advanced malignancies showing no evidence of disease after standard treatment when injected with HER2/neu intracellular domain protein pulsed autologous dendritic cells.\n* Assess time to recurrence in these patients.\n\nOUTLINE: Autologous dendritic cells (DC) are pulsed with HER2/neu intracellular domain protein (ICD). The pulsed DC are administered subcutaneously (SQ) and intradermally, followed by autologous DC mixed with tetanus toxoid (TT) and autologous DC mixed with keyhole limpet hemocyanin (KLH) SQ and intradermally on day 1. HLA-A2 positive patients also receive autologous DC mixed with CMV pp65 peptide SQ and intradermally on day 1. Treatment continues every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 1 year or until disease progression.\n\nPROJECTED ACCRUAL: A total of 6 patients will be accrued for this study over 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed advanced malignancy that expresses HER2/neu\n\n * Stage IIA breast cancer with more than 6 positive lymph nodes\n * Stage IIB, IIIA, or IIIB breast cancer\n * Stage III ovarian cancer\n * Lymph node positive gastric cancer\n * Metastatic tumor\n* No measurable or evaluable disease after standard treatment\n* No previously irradiated or newly diagnosed CNS metastases\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* Karnofsky 80-100%\n\nLife expectancy:\n\n* Greater than 6 months\n\nHematopoietic:\n\n* WBC at least 3,000/mm\\^3\n* Hemoglobin at least 9 mg/dL\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 2.0 mg/dL\n* No hepatic disease, including viral hepatitis\n\nRenal:\n\n* Creatinine less than 2.5 mg/dL\n\nCardiovascular:\n\n* No New York Heart Association class III or IV heart disease\n\nPulmonary:\n\n* No asthma or chronic obstructive pulmonary disease\n\nImmunologic:\n\n* Must have positive intradermal delayed hypersensitivity test for at least 1 of the following:\n\n * Candida\n * Mumps\n * Tetanus\n * Trichophyton\n * Histoplasmin\n* No prior autoimmune disease including, but not limited to, the following:\n\n * Inflammatory bowel disease\n * Systemic lupus erythematosus\n * Ankylosing spondylitis\n * Scleroderma\n * Multiple sclerosis\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* HIV negative\n* Hepatitis B surface antigen and hepatitis C antibody negative\n* No other concurrent serious chronic or acute illness or infection (including urinary tract infection)\n* No known shellfish or iodine allergy\n* No other prior or concurrent malignancy except for nonmelanoma skin cancer, cervical cancer, or controlled superficial bladder cancer\n* No medical or psychological condition that may preclude study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No other concurrent immunotherapy\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy and recovered\n* No concurrent chemotherapy\n\nEndocrine therapy:\n\n* Concurrent hormonal therapy allowed (tamoxifen, raloxifene, toremifene, and all aromatase inhibitors)\n* At least 4 weeks since prior steroid or immunosuppressive therapy (e.g, azathioprine or cyclosporine)\n\nRadiotherapy:\n\n* Prior radiotherapy allowed except to cranium\n* At least 4 weeks since prior radiotherapy and recovered\n* At least 12 weeks since prior strontium chloride Sr 89\n* No concurrent radiotherapy\n\nSurgery:\n\n* At least 4 weeks since prior surgery and recovered\n\nOther:\n\n* Concurrent bisphosphonates allowed\n* No prior hepatitis B immunization'}, 'identificationModule': {'nctId': 'NCT00005956', 'briefTitle': 'Biological Therapy in Treating Patients With Advanced Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Pilot Study of Active Immunotherapy With HER2/Neu Intracellular Domain (ICD) Protein-Pulsed, Autologous, Cultured Dendritic Cells in Patients With No Evidence of Disease After Standard Treatment for HER2/Neu Expressing Malignancies', 'orgStudyIdInfo': {'id': '1309'}, 'secondaryIdInfos': [{'id': '6542', 'type': 'OTHER', 'domain': 'FDA'}, {'id': '1528', 'type': 'OTHER', 'domain': 'DUMC IRB'}, {'id': 'CDR0000067937', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'HER-2/neu intracellular domain protein', 'type': 'BIOLOGICAL', 'otherNames': ['HER2 ICD']}, {'name': 'therapeutic autologous dendritic cells', 'type': 'BIOLOGICAL', 'otherNames': ['DC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Michael A. Morse, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}