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

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: NCT00004024
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 5, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Biological: aldesleukin Biological: autologous tumor cell vaccine Biological: muromonab-CD3 Biological: sargramostim Biological: therapeutic autologous lymphocytes Procedure: surgical procedure Radiation: radiation therapy Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy
Study Start Date : June 1997
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

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


  • 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



  • 18 and over

Performance status:

  • SWOG 0 or 1

Life expectancy:

  • At least 6 months


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


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


  • Creatinine normal


  • 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


Biologic therapy:

  • Not specified


  • No concurrent chemotherapy except for progressive disease

Endocrine therapy:

  • See Disease Characteristics


  • Radium implants allowed


  • Not specified


  • At least 1 week since prior therapy and recovered

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): NCT00004024

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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
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Study Chair: Andrew E. Sloan, MD Barbara Ann Karmanos Cancer Institute

Publications of Results:
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Responsible Party: Barbara Ann Karmanos Cancer Institute Identifier: NCT00004024     History of Changes
Obsolete Identifiers: NCT00004018, NCT00004019, NCT00004020, NCT00004021, NCT00004023
Other Study ID Numbers: CDR0000067243
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013

Keywords provided by Barbara Ann Karmanos Cancer Institute:
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult subependymoma
adult oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma
adult diffuse astrocytoma

Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents