Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma

April 3, 2013 updated by: Barbara Ann Karmanos Cancer Institute

Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery and radiation therapy in treating patients who have primary or recurrent astrocytoma or oligodendroglioma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the efficacy of immunotherapy with irradiated autologous tumor cell vaccine and adoptive immunotherapy, in terms of time to progression and median and one-year survival, in patients with primary or recurrent malignant astrocytoma or oligodendroglioma.
  • Determine the immunogenicity of malignant gliomas in patients treated with this regimen.

OUTLINE: Patients are stratified according to extent of disease, extent of antigen-specific response to vaccination, performance status (0 vs 1), prior therapy (yes vs no), and gender.

Patients undergo tumor resection on week 1. Patients without recurrent disease receive local radiotherapy on weeks 2-8. Beginning week 10-12, patients are vaccinated with irradiated autologous tumor cells and sargramostim (GM-CSF) and then receive GM-CSF alone intradermally at vaccination sites daily for 4 days. Patients are revaccinated 4 weeks later and may receive up to 3 additional vaccinations every 2 weeks until a response is detected.

Patients undergo peripheral blood mononuclear cell collection on week 14 followed by monoclonal antibody OKT3-activated T lymphocytes IV over 1-6 hours with alternating interleukin-2 IV once every other day for 5 doses over 10 days beginning on week 16. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients may receive one additional course of immunotherapy as above.

Patients are followed at 1 week, monthly for 3 months, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

60

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
    • Michigan
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute

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 proven grade II, III, or IV astrocytoma or oligodendroglioma

    • Evidence of primary or recurrent tumor by MRI

    • Resectable disease

      • At least 20,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • SWOG 0 or 1

Life expectancy:

  • At least 6 months

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least lower limit of normal
  • No active or recent uncontrolled bleeding

Hepatic:

  • Bilirubin normal
  • SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)

Renal:

  • Creatinine normal

Other:

  • Able to be weaned off steroids
  • Negative stool guaiac
  • No impaired immunity
  • No uncontrolled diabetes
  • No active uncontrolled infections
  • No other serious disease
  • No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
  • No psychological, familial, sociological, or geographical conditions that would preclude compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No concurrent chemotherapy except for progressive disease

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • Radium implants allowed

Surgery:

  • Not specified

Other

  • At least 1 week since prior therapy and recovered

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
  • Masking: NONE

Collaborators and Investigators

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

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Andrew E. Sloan, MD, Barbara Ann Karmanos Cancer Institute

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

June 1, 1997

Primary Completion (ACTUAL)

January 1, 2004

Study Completion (ACTUAL)

January 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 3, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067243
  • P30CA022453 (U.S. NIH Grant/Contract)
  • WSU-C-1403-BT
  • NCI-G99-1567

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.

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