Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-29 @ 9:06 AM
Study NCT ID:
NCT00004032
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
1999-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007371', 'term': 'Interferon-gamma'}, {'id': 'C554125', 'term': 'interferon gamma-1b'}], 'ancestors': [{'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D016215', 'term': 'Macrophage-Activating Factors'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-22', 'studyFirstSubmitDate': '1999-12-10', 'studyFirstSubmitQcDate': '2003-08-22', 'lastUpdatePostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autologous tumor cell cytotoxicity lymphocyte (CTL)', 'timeFrame': 'Up to 7 years'}, {'measure': 'Cytokine production (IFN gamma, IL-10, IL-2) by RT-PCR', 'timeFrame': 'Up to 7 years'}, {'measure': 'Toxicity as assessed by NCI Common Terminology Criteria (CTC)', 'timeFrame': '3 weeks'}]}, 'conditionsModule': {'conditions': ['Recurrent Ovarian Epithelial Cancer']}, 'descriptionModule': {'briefSummary': "Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer. Vaccines made from a person's cancer cells may make the body build an immune response to and kill their tumor cells. Combining vaccine therapy with interferon gamma may be a more effective treatment for epithelial ovarian cancer", 'detailedDescription': 'OBJECTIVES:\n\nI. Determine whether intraperitoneal (IP) injections of epithelial ovarian carcinoma cells infected with ALVAC-hB7.1 and IP interferon gamma have acceptable toxicity and produce any clinical responses in patients with refractory ovarian epithelial cancer.\n\nOUTLINE: This is a dose-escalation study of ALVAC-hB7.1 infected tumor cells.\n\nPatients receive ALVAC-hB7.1 infected tumor cells intraperitoneally (IP) on days 4, 11, and 18. Patients also receive interferon gamma IP on days 8, 10, 15, and 17. In the absence of disease progression, up to 6 courses of therapy may be given. If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine, interferon gamma may be given alone. Cohorts of 3 to 6 patients receive escalating doses of ALVAC-hB7.1 infected tumor cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity.\n\nPatients are followed every 6 months until disease progression.\n\nPROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ovarian epithelial carcinoma\n* Previously treated with an adequate course of platinum based chemotherapy\n* Evidence of intraabdominal disease\n* No significant adhesions\n* Performance status - Zubrod 0-2\n* Lymphocyte count at least 500/mm\\^3\n* Bilirubin no greater than 1.5 mg/dL\n* SGOT less than 2.5 times upper limit of normal\n* Creatinine no greater than 1.5 mg/dL\n* No major disorder of the cardiovascular system\n* No major disorder of the pulmonary system\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* Successful placement of peritoneal catheter\n* No overt autoimmune disease\n* No concurrent chronic steroid therapy\n* No prior radiotherapy\n* Prior surgery allowed\n* Recovered from prior therapy'}, 'identificationModule': {'nctId': 'NCT00004032', 'briefTitle': 'Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-h.B7.1 Plus IP rIFN-gamma for Patients With Ovarian Cancer. A Pilot Study', 'orgStudyIdInfo': {'id': 'NCI-2012-02255'}, 'secondaryIdInfos': [{'id': 'MDA-ID-96253'}, {'id': 'U01CA062461', 'link': 'https://reporter.nih.gov/quickSearch/U01CA062461', 'type': 'NIH'}, {'id': 'CDR0000065850', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (ALVAC-hB7.1, recombinant interferon gamma)', 'description': 'Patients receive ALVAC-hB7.1 infected tumor cells intraperitoneally (IP) on days 4, 11, and 18. Patients also receive interferon gamma IP on days 8, 10, 15, and 17. In the absence of disease progression, up to 6 courses of therapy may be given. If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine, interferon gamma may be given alone.', 'interventionNames': ['Biological: ALVAC-hB7.1', 'Biological: recombinant interferon gamma', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'ALVAC-hB7.1', 'type': 'BIOLOGICAL', 'description': 'Given IP', 'armGroupLabels': ['Treatment (ALVAC-hB7.1, recombinant interferon gamma)']}, {'name': 'recombinant interferon gamma', 'type': 'BIOLOGICAL', 'otherNames': ['Actimmune', 'gamma interferon', 'IFN-G'], 'description': 'Given IP', 'armGroupLabels': ['Treatment (ALVAC-hB7.1, recombinant interferon gamma)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (ALVAC-hB7.1, recombinant interferon gamma)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ralph Freedman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}