Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-02 @ 11:21 AM
Study NCT ID:
NCT00107159
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2005-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2005-04-05', 'studyFirstSubmitQcDate': '2005-04-05', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-04-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety'}, {'measure': 'Immune response'}]}, 'conditionsModule': {'keywords': ['recurrent melanoma', 'stage III melanoma', 'stage IV melanoma'], 'conditions': ['Melanoma (Skin)']}, 'referencesModule': {'references': [{'pmid': '20875102', 'type': 'RESULT', 'citation': 'Ribas A, Camacho LH, Lee SM, Hersh EM, Brown CK, Richards JM, Rodriguez MJ, Prieto VG, Glaspy JA, Oseguera DK, Hernandez J, Villanueva A, Chmielowski B, Mitsky P, Bercovici N, Wasserman E, Landais D, Ross MI. Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma. J Transl Med. 2010 Sep 27;8:89. doi: 10.1186/1479-5876-8-89.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Vaccines made from a person's white blood cells and a donor's tumor cells may help the body build an effective immune response to kill tumor cells.\n\nPURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with unresected stage III or stage IV melanoma.", 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the clinical activity of vaccine therapy comprising autologous dendritic cells pulsed with allogeneic melanoma tumor cell lysates (IDD-3), as measured by tumor control, in patients with unresected stage IIIB or IIIC or stage IV melanoma.\n\nSecondary\n\n* Determine the immunologic activity of this vaccine, as measured by T-cell and antibody responses to lysate or to melanoma antigens or peptides, in these patients.\n* Determine the safety of this vaccine, as measured by the incidence and severity of adverse events, in these patients.\n\nOUTLINE: This is an open-label, multicenter study.\n\nPatients undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). The PBMCs are cultured with sargramostim (GM-CSF) and interleukin-13 for the production of dendritic cells. The dendritic cells are then pulsed with lysates from 3 allogeneic melanoma tumor cell lines (IDD-3) to produce the vaccine.\n\nPatients receive vaccine therapy comprising IDD-3 administered as 1 subcutaneous and 5 intradermal injections at each of the 2 uninvolved lymph node-bearing regions once in weeks 0, 2, 4, 6, 8, 10, 16, and 22 in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed at 2, 10, 18, and 26 weeks.\n\nPROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary cutaneous or unknown primary melanoma, including 1 of the following stages:\n\n * Stage IIIB or IIIC disease\n\n * Unresected, in-transit lymph node metastases (N2c or N3)\n * Stage IV disease\n\n * Distant skin, subcutaneous, lymph node, or pulmonary metastases (M1a or M1b)\n\n * No cerebral, bone, or other visceral metastases\n* At least 1 measurable or evaluable lesion\n\n * Small-volume multiple cutaneous deposits allowed\n* Progressive disease, as defined by 1 of the following criteria:\n\n * At least 20% increase in size in ≥ 1 measurable or evaluable lesion\n * Appearance of ≥ 1 new lesion since or during last treatment (if applicable) AND within the past 3 months\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* At least 6 months\n\nHematopoietic\n\n* WBC ≥ 3,000/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 10.0 g/dL (transfusion allowed)\n\nHepatic\n\n* SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)\n* Lactic dehydrogenase normal\n* No active hepatitis B or C infection\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n\nImmunologic\n\n* No history of autoimmune disease\n\n * Vitiligo allowed\n* No history of immunodeficiency syndrome\n* No active bacterial, viral, or fungal infection within the past 72 hours\n* HIV-1 or -2 negative\n* Human T-cell lymphotrophic virus-I or -II negative\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* No contraindication to apheresis\n* No other significant medical or surgical condition that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior vaccine therapy with ≥ 1 melanoma antigen or peptide\n* More than 4 weeks since prior biologic therapy\n\nChemotherapy\n\n* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)\n\nEndocrine therapy\n\n* No concurrent chronic systemic corticosteroids\n\nRadiotherapy\n\n* More than 4 weeks since prior radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* More than 4 weeks since prior investigational products\n* More than 4 weeks since prior chronic systemic immunosuppressive treatment\n* No concurrent medication or treatment regimen that would prelude study participation\n* No other concurrent anticancer treatment\n* No other concurrent immunosuppressive treatment'}, 'identificationModule': {'nctId': 'NCT00107159', 'briefTitle': 'Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Study Of Matured Dendritic Cells Pulsed Ex Vivo With 3 Melanoma Cell Line Lysates (IDD-3) in Patients With In-Transit or Metastatic Melanoma', 'orgStudyIdInfo': {'id': 'CDR0000422429'}, 'secondaryIdInfos': [{'id': 'UCLA-0408080-01'}, {'id': 'IDM-DC-MEL-202'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Antoni Ribas, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}