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Tumor Cell Vaccine in Treating Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002505
Recruitment Status : Completed
First Posted : June 28, 2004
Last Update Posted : May 12, 2011
Cancer Biotherapy Research Group
Information provided by:
Hoag Memorial Hospital Presbyterian

Brief Summary:

RATIONALE: Vaccines made from the patient's cancer cells may make the body build an immune response and kill their tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of autologous tumor cell vaccination plus immunologic adjuvant in treating patients who have metastatic cancer.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Biological: filgrastim Biological: recombinant interferon gamma Biological: tumor cell lysate vaccine therapy Phase 2

Detailed Description:

OBJECTIVES: I. Determine the toxic effects and side effects associated with administration of autologous tumor cell vaccine together with adjuvant interferon gamma or sargramostim (GM-CSF) in patients with advanced cancer. II. Determine the rate of conversion of delayed tumor hypersensitivity in patients receiving subcutaneous injections of irradiated autologous tumor cells (autologous vaccine). III. Determine the effect of autologous vaccines on in vitro assays of immune antitumor activity. IV. Determine the failure free survival associated with the use of autologous tumor cell line vaccines in patients with advanced cancer.

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : August 1992
Actual Primary Completion Date : August 2002
Actual Study Completion Date : May 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed cancer with documented regional lymph node or distant metastases not considered cured by standard therapy Achievement of maximum benefit (i.e., CR or PR) from cytoreductive therapy prior to entry allowed Eligible tumor types include: Breast Prostate Colorectal Sarcoma Lung Renal cell Melanoma Large resected primary cancers at risk for recurrence and for which no standard adjuvant therapy available Viable autologous tumor cells derived from an autologous tumor cell line required No active brain metastases Previously treated and responsive brain metastases allowed unless corticosteroid dependent

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 30% Hepatic: Bilirubin less than 2.0 mg/dL PT and PTT normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure requiring medication Pulmonary: Respiratory reserve must be reasonable No requirement for supplemental oxygen No dyspnea at rest

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002505

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United States, California
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
United States, Indiana
Bloomington Hospital
Bloomington, Indiana, United States, 47402
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
United States, Nebraska
Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian
Cancer Biotherapy Research Group
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Study Chair: Robert O. Dillman, MD, FACP Cancer Biotherapy Research Group
Publications of Results:
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, 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.
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.

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Responsible Party: Robert O. Dillman, MD, Hoag Memorial Hospital Presbyterian Identifier: NCT00002505    
Other Study ID Numbers: CDR0000077951
First Posted: June 28, 2004    Key Record Dates
Last Update Posted: May 12, 2011
Last Verified: May 2011
Keywords provided by Hoag Memorial Hospital Presbyterian:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs