Tumor Cell Vaccine in Treating Patients With Advanced Cancer
NCT ID: NCT00002505
Last Updated: 2011-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1992-08-31
2006-05-31
Brief Summary
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PURPOSE: Randomized phase II trial to study the effectiveness of autologous tumor cell vaccination plus immunologic adjuvant in treating patients who have metastatic cancer.
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Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, tumor type, disease stage, remission status (complete vs partial), prior therapy, progressive disease (yes vs no), and performance status (ECOG 0-1 vs 2). Patients are randomized into one of two treatment arms. Arm I: Patients receive vaccination with irradiated autologous tumor cells subcutaneously (SQ) on week 1 and then autologous tumor cell vaccine plus interferon gamma SQ on weeks 2 and 3, and then monthly beginning on week 8 and continuing until week 24. Arm II: Patients receive vaccination with irradiated autologous tumor cells as in arm I and then autologous tumor cell vaccine plus sargramostim (GM-CSF) SQ on weeks 2 and 3 and then monthly beginning on week 8 and continuing until week 24.
PROJECTED ACCRUAL: A total of 20-30 patients from each major tumor type (breast, lung, prostate, colorectal, sarcoma, renal, melanoma) will be accrued for this study.
Conditions
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Study Design
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TREATMENT
Interventions
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filgrastim
recombinant interferon gamma
tumor cell lysate vaccine therapy
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed No concurrent biologic therapy (including cyclosporine) Chemotherapy: At least 24 hours since prior cyclophosphamide At least 4 weeks since other systemic antineoplastic chemotherapy and recovered Endocrine therapy: Homeopathic corticosteroids allowed At least 4 weeks since prior corticosteroids No other concurrent corticosteroids Radiotherapy: Prior radiotherapy allowed Surgery: Prior surgery allowed
18 Years
ALL
No
Sponsors
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Cancer Biotherapy Research Group
OTHER
Hoag Memorial Hospital Presbyterian
OTHER
Responsible Party
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Hoag Memorial Hospital Presbyterian
Principal Investigators
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Robert O. Dillman, MD, FACP
Role: STUDY_CHAIR
Cancer Biotherapy Research Group
Locations
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Bloomington Hospital
Bloomington, Indiana, United States
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
Bergan Mercy Medical Center
Omaha, Nebraska, United States
Countries
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References
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Dillman RO, Nayak SK, Beutel LD, et al.: Short-term cultures of kidney cancer cells for use as autologous tumor cell vaccines in the treatment of renal cell carcinoma. [Abstract] Proc Am Assoc Cancer Res 40: A1672, 1999.
Dillman RO, Nayak SK, Brown JV, et al.: Short-term cell cultures of ovarian cancer cells for use as autologous tumor cell vaccines as adjuvant therapy of advanced ovarian cancer. [Abstract] Proc Am Assoc Cancer Res 39: A2501, 1998.
Dillman RO, Nayak SK, Barth NM, DeLeon C, Schwartzberg LS, Spitler LE, Church C, O'Connor AA, Beutel LD. Clinical experience with autologous tumor cell lines for patient-specific vaccine therapy in metastatic melanoma. Cancer Biother Radiopharm. 1998 Jun;13(3):165-76. doi: 10.1089/cbr.1998.13.165.
Dillman RO, Nayak SK, Johnson D, et al.: The potential to use short-term cultures of ovarian cells as autologous tumor cell vaccines. [Abstract] Proc Am Assoc Cancer Res 38: A2676, 1997.
Dillman R, Nayak S, Barth N, et al.: Irradiated, cultured, autologous tumor cells for active specific immunotherapy. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A1810, 546, 1995.
Nayak SK, Meusch T, Dillman RO: Autologous human tumor cell lines established in tissue culture for active specific immunotherapy. [Abstract] J Immunother 17 (2): 123, 1995.
Dillman RO, Nayak SK, Beutel L. Establishing in vitro cultures of autologous tumor cells for use in active specific immunotherapy. J Immunother Emphasis Tumor Immunol. 1993 Jul;14(1):65-9. doi: 10.1097/00002371-199307000-00009.
Dillman RO, Wiemann M, Nayak SK, DeLeon C, Hood K, DePriest C. Interferon-gamma or granulocyte-macrophage colony-stimulating factor administered as adjuvants with a vaccine of irradiated autologous tumor cells from short-term cell line cultures: a randomized phase 2 trial of the cancer biotherapy research group. J Immunother. 2003 Jul-Aug;26(4):367-73. doi: 10.1097/00002371-200307000-00009.
Nayak SK, Dillman RO: Use of autologous tumor cells grown in tissue culture for active specific immunotherapy. [Abstract] Proc Am Assoc Cancer Res 34: A-2937, 1993.
Other Identifiers
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CBRG-9212
Identifier Type: -
Identifier Source: secondary_id
NBSG-9212
Identifier Type: -
Identifier Source: secondary_id
NCI-V92-0155
Identifier Type: -
Identifier Source: secondary_id
CDR0000077951
Identifier Type: -
Identifier Source: org_study_id
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