Tumor Cell Vaccine in Treating Patients With Advanced Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Biological: filgrastim Biological: recombinant interferon gamma Biological: tumor cell lysate vaccine therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | RANDOMIZED PHASE II TRIAL OF AUTOLOGOUS TUMOR CELL VACCINE |
| Study Start Date: | August 1992 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 | |
| Study Chair: | Robert O. Dillman, MD, FACP | Cancer Biotherapy Research Group |
More Information
Additional Information:
Publications:
| Responsible Party: | Robert O. Dillman, MD, Hoag Memorial Hospital Presbyterian |
| ClinicalTrials.gov Identifier: | NCT00002505 History of Changes |
| Other Study ID Numbers: | CDR0000077951, CBRG-9212, NBSG-9212, NCI-V92-0155 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Hoag Memorial Hospital Presbyterian:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Interferon-gamma Interferons Lenograstim Antiviral Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Antineoplastic Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013