Biological Therapy in Treating Patients With Primary or Advanced Glioma

February 6, 2009 updated by: Weill Medical College of Cornell University

Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

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
    • New York
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital

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 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

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

Collaborators and Investigators

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

Sponsor

Weill Medical College of Cornell University

Investigators

  • Study Chair: Roberta L. Hayes, PhD, Immune Therapy, LLC

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

July 1, 1997

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)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 6, 2009

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065739
  • NYWCCC-0902499
  • NYWCCC-IMMUNE-0902499
  • SIUH-RP-96-004
  • NCI-V97-1326

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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