Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-03-03 @ 7:07 PM
Study NCT ID:
NCT00317759
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2006-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042382', 'term': 'fludarabine phosphate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-30', 'studyFirstSubmitDate': '2006-04-24', 'studyFirstSubmitQcDate': '2006-04-24', 'lastUpdatePostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage IV melanoma', 'recurrent melanoma'], 'conditions': ['Melanoma (Skin)']}, 'referencesModule': {'references': [{'pmid': '19270751', 'type': 'RESULT', 'citation': 'Wallen H, Thompson JA, Reilly JZ, Rodmyre RM, Cao J, Yee C. Fludarabine modulates immune response and extends in vivo survival of adoptively transferred CD8 T cells in patients with metastatic melanoma. PLoS One. 2009;4(3):e4749. doi: 10.1371/journal.pone.0004749. Epub 2009 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Fludarabine may help the immune system kill more cancer cells.\n\nPURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have metastatic melanoma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8+ antigen-specific cytotoxic T-lymphocyte (CTL) clones after fludarabine in patients with stage IV melanoma.\n* Determine the duration of in vivo persistence of these CTL clones in these patients.\n\nSecondary\n\n* Determine the antitumor effect of this regimen in these patients.\n\nOUTLINE: This is an open-label, nonrandomized study.\n\nPatients undergo leukapheresis or weekly phlebotomy for the collection of peripheral blood mononuclear cells from which autologous antigen-specific CD8+ cytotoxic T-lymphocyte (CTL) clones are generated. Patients receive autologous antigen-specific CD8+ CTL clones IV over 30-60 minutes on days 0 and 21 in the absence of rapid disease progression or unacceptable toxicity. Patients also receive fludarabine IV once daily on days 14-18.\n\nPatients are followed for up to 1 year.\n\nPROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic melanoma\n\n * Stage IV disease\n* HLA-A2 or -A3-expressing disease\n* Bidimensionally measurable residual disease by palpation or radiographic imaging (e.g., x-ray or CT scan)\n* No CNS metastases\n\n * Previously treated CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after completion of therapy\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 75\n\nPerformance status\n\n* Karnofsky 80-100%\n\nLife expectancy\n\n* More than 6 months\n\nHematopoietic\n\n* Platelet count \\> 100,000/mm\\^3\n* Absolute neutrophil count \\> 2,000/mm\\^3\n\nHepatic\n\n* SGOT no greater than 3 times upper limit of normal\n* Bilirubin no greater than 1.6 mg/dL\n* INR no greater than 1.5 times normal\n\nRenal\n\n* Creatinine no greater than 2.0 mg/dL OR\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular\n\n* No congestive heart failure\n* No clinically significant hypotension\n* No symptoms of coronary artery disease\n* No cardiac arrhythmia by EKG requiring drug therapy\n\nPulmonary\n\n* No clinically significant pulmonary dysfunction\n* FEV\\_1 at least 1.0 L\\*\n* DLCO at least 45%\\* NOTE: \\*For patients with a history of pulmonary dysfunction\n\nImmunologic\n\n* No active infection\n* No oral temperature greater than 38.2°C within the past 48 hours\n* No systemic infection requiring chronic maintenance or suppressive therapy\n\nOther\n\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* No concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulins, expanded polyclonal tumor-infiltrating lymphocytes, or lymphokine-activated killer therapy)\n\nChemotherapy\n\n* At least 3 weeks since prior chemotherapy (standard or experimental)\n\nEndocrine therapy\n\n* No concurrent steroids\n\nRadiotherapy\n\n* At least 3 weeks since prior radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 3 weeks since prior immunosuppressive therapy\n* No concurrent pentoxifylline\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00317759', 'briefTitle': 'Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma', 'orgStudyIdInfo': {'id': '1796.00'}, 'secondaryIdInfos': [{'id': 'FHCRC-1796.00'}, {'id': 'CDR0000327817', 'type': 'REGISTRY', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'therapeutic autologous lymphocytes', 'type': 'BIOLOGICAL'}, {'name': 'fludarabine phosphate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Cassian Yee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}