Tumor Cell Vaccine in Treating Patients With Advanced Cancer

May 10, 2011 updated by: Hoag Memorial Hospital Presbyterian

RANDOMIZED PHASE II TRIAL OF AUTOLOGOUS TUMOR CELL VACCINE

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92658
        • Hoag Memorial Hospital Presbyterian
    • Indiana
      • Bloomington, Indiana, United States, 47402
        • Bloomington Hospital
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital and Health Care Center
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Bergan Mercy Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoag Memorial Hospital Presbyterian

Collaborators

Cancer Biotherapy Research Group

Investigators

  • Study Chair: Robert O. Dillman, MD, FACP, Cancer Biotherapy Research Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1992

Primary Completion (Actual)

August 1, 2002

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

June 25, 2004

First Posted (Estimate)

June 28, 2004

Study Record Updates

Last Update Posted (Estimate)

May 12, 2011

Last Update Submitted That Met QC Criteria

May 10, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000077951
  • CBRG-9212
  • NBSG-9212
  • NCI-V92-0155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Unspecified Adult Solid Tumor, Protocol Specific

Clinical Trials on recombinant interferon gamma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe