Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-02-20 @ 6:37 PM
Study NCT ID:
NCT00276003
Status:
COMPLETED
Last Update Posted:
2010-01-07
First Post:
2006-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000493', 'term': 'Allopurinol'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-06', 'studyFirstSubmitDate': '2006-01-11', 'studyFirstSubmitQcDate': '2006-01-11', 'lastUpdatePostDateStruct': {'date': '2010-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Assess progression free survival in these patients with this regimen.', 'timeFrame': '3 years'}, {'measure': 'Assess toxicity of this regimen in this group of patients.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lymphoma-Non Hodgkins', 'Phase II', 'Gemcitabine', 'Irinotecan'], 'conditions': ["Non-Hodgkin's Lymphoma", 'Cancer']}, 'descriptionModule': {'briefSummary': 'Primary objectives\n\n* Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.\n\nSecondary objectives\n\n* Assess progression free survival in these patients treated with this regimen.\n* Assess toxicity of this regimen in this group of patients.', 'detailedDescription': 'The purpose of the study is to see how well patients with relapsed or refractory lymphoma respond to treatment with Gemcitabine and Irinotecan. Patients on this study take part because they have relapsed or refractory lymphoma. Additionally, the study will assess treatment-related side effects and time until disease progression or recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a histologic diagnosis of non-HIV related B-cell NHL or Hodgkins disease are eligible.\n2. Patients should have documented evidence of refractory or relapsed NHL or Hodgkins disease for inclusion.\n3. Patient should have received 1 or more prior chemotherapeutic regimens for relapse, and should have completed last course of treatment at least 3 weeks prior to enrollment.\n4. The patient must have bidimensionally measurable or evaluable disease.\n5. Age \\> 18 years.\n6. ECOG Performance status \\< 2\n7. Informed consent.\n8. ANC \\> 1.5, platelet count \\> 100K, creatinine\\< 2.0, bilirubin \\< 3\n9. Female patients must have a negative pregnancy test.'}, 'identificationModule': {'nctId': 'NCT00276003', 'briefTitle': 'INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.', 'orgStudyIdInfo': {'id': '0101C'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gemcitabine, Irinotecan, Allopurinol.', 'type': 'DRUG', 'description': 'Gemcitabine - 1000mg/m2; IV; d1, 8; q 21 days Irinotecan - 100mg/m2; IV; d1, 8; q 21 days Allopurinol - 300 mg; PO; day 1-5; 1st cycle'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87108', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Lovelace Sandia Health Systems Dept of Hematology', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Ian Rabinowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ian Rabinowitz, MD; Principal Investigator', 'oldOrganization': 'University of New Mexico - CRTC'}}}}