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Biological Therapy in Treating Patients With Primary or Advanced Glioma
This study has been suspended.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsored by: Weill Medical College of Cornell University
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003067
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Biological: aldesleukin
Biological: lymphokine-activated killer cells
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 1997
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance Status:

  • Karnofsky 60-100%

Life Expectancy:

  • Greater than 4 months

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal

Renal:

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

Cardiovascular:

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

Pulmonary:

  • No major pulmonary problems

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • Prior surgery is allowed

Other:

  • Concurrent therapy with acetaminophen, anticonvulsant agents, and headache pain medications is allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003067

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

Additional Information:
Publications:
Study ID Numbers: CDR0000065739, NYWCCC-0902499, NYWCCC-IMMUNE-0902499, SIUH-RP-96-004, NCI-V97-1326
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003067     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Anti-Infective Agents
Glioblastoma
Anti-HIV Agents
Astrocytoma
Central Nervous System Neoplasms
Antiviral Agents
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Aldesleukin
Anti-Retroviral Agents
Interleukin-2
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Central Nervous System Neoplasms
Antiviral Agents
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Aldesleukin
Anti-Retroviral Agents
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009