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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute Identifier:
First received: November 1, 1999
Last updated: April 3, 2013
Last verified: April 2013

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 Intervention 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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy

Resource links provided by NLM:

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Estimated Enrollment: 60
Study Start Date: June 1997
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00004024

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)
Study Chair: Andrew E. Sloan, MD Barbara Ann Karmanos Cancer Institute
  More Information

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 ( US NIH Grant/Contract Award Number )
Study First Received: November 1, 1999
Last Updated: April 3, 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:
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
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on April 21, 2017