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Biological Therapy in Treating Patients With Primary or Advanced Glioma

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ClinicalTrials.gov Identifier: NCT00003067
Recruitment Status : Suspended
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells in patients with primary or advanced glioma.

PURPOSE: Clinical trial to study the effectiveness of biological therapy with interleukin-2 and lymphokine-activated killer cells in treating patients who have primary, recurrent, or refractory malignant glioma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Biological: aldesleukin Biological: lymphokine-activated killer cells Phase 2

Detailed Description:


  • Confirm the antitumor efficacy of intracavitary interleukin-2 plus autologous lymphokine-activated killer cells in patients with primary, recurrent or refractory malignant gliomas.
  • Determine whether the induction of a regional, intracavitary, eosinophilia is a prognosticator of response to immunotherapy and long term survival in these patients.

OUTLINE: Patients receive cytoreductive tumor surgery and/or biopsy and implantation of intracavitary Ommaya reservoir prior to therapy induction.

Patients undergo outpatient leukapheresis on day -4 or -5, and cells are incubated ex vivo with interleukin-2 (IL-2). Lymphokine-activated killer (LAK) cells and IL-2 are infused on day 1. Bolus infusions of low-dose IL-2 are administered on days 3, 5, 8, 10, and 12, followed by a rest period on days 13-24. The course is repeated on day 25 starting with leukapheresis. Therapy courses are repeated for up to 1 year for stable disease or response to therapy. Maintenance doses repeat every 4-6 months thereafter.

Disease restaging is done every 8-12 weeks.

PROJECTED ACCRUAL: A total of 30 patients per year will be enrolled.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas
Study Start Date : July 1997

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or radiographically proven primary, recurrent, or refractory malignant gliomas (glioblastoma, anaplastic astrocytoma, and mixed anaplastic glioma)

    • Must be a candidate for neurosurgical biopsy or tumor debulking



  • 18 and over

Performance Status:

  • Karnofsky 60-100%

Life Expectancy:

  • Greater than 4 months


  • Granulocytes greater than 1,500/mm^3
  • Platelet count greater than 50,000/mm^3
  • PT and PTT within normal limits


  • Bilirubin no greater than 1.5 times upper limit of normal


  • Creatinine less than 1.5 mg/dL
  • Creatinine clearance greater than 60 mL/min


  • No congestive heart failure
  • No coronary artery disease
  • No serious cardiac arrhythmias
  • No prior myocardial infarction


  • No major pulmonary problems


  • No history of neurologic disease (except related to brain tumor)
  • No psychosis
  • No impaired cognitive function
  • No significant concurrent medical illness
  • No active infection requiring antibiotic therapy
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Adequate peripheral veins to permit leukapheresis, or placement of indwelling central vascular access device
  • No hepatitis B or C
  • HIV negative
  • No prior autoimmune disease
  • Allergy to gentamicin is allowed


Biologic therapy:

  • At least 6 weeks since prior immunotherapy and recovered
  • No concurrent immunotherapy


  • At least 4 weeks since prior chemotherapy (6 weeks for carmustine) and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • Reduction or elimination of corticosteroids
  • Not greater than 0.15 mg/kg/day dexamethasone equivalent


  • At least 6 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy


  • Prior surgery is allowed


  • Concurrent therapy with acetaminophen, anticonvulsant agents, and headache pain medications is allowed

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 ClinicalTrials.gov identifier (NCT number): NCT00003067

United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Weill Medical College of Cornell University
Study Chair: Roberta L. Hayes, PhD Immune Therapy, LLC

ClinicalTrials.gov Identifier: NCT00003067     History of Changes
Other Study ID Numbers: CDR0000065739
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: October 2008

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

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
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents