Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Tumor Cell Vaccine in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Cancer Biotherapy Research Group
Information provided by:
Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier:
NCT00002505
First received: November 1, 1999
Last updated: May 10, 2011
Last verified: May 2011
  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

Resource links provided by NLM:


Further study details as provided by Hoag Memorial Hospital Presbyterian:

Study Start Date: August 1992
Study Completion Date: May 2006
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002505

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
Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian
Cancer Biotherapy Research Group
Investigators
Study Chair: Robert O. Dillman, MD, FACP Cancer Biotherapy Research Group
  More Information

Additional Information:
Publications:
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.

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:
Neoplasms
Interferon-gamma
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014