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Biological Therapy in Treating Patients With Primary or Advanced Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
lymphokine-activated killer cells
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Staten Island University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 6, 2009
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT00003067
Brief Title
Biological Therapy in Treating Patients With Primary or Advanced Glioma
Official Title
Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Suspended
Study Start Date
July 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
lymphokine-activated killer cells

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberta L. Hayes, PhD
Organizational Affiliation
Immune Therapy, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8625188
Citation
Hayes RL, Koslow M, Hiesiger EM, Hymes KB, Hochster HS, Moore EJ, Pierz DM, Chen DK, Budzilovich GN, Ransohoff J. Improved long term survival after intracavitary interleukin-2 and lymphokine-activated killer cells for adults with recurrent malignant glioma. Cancer. 1995 Sep 1;76(5):840-52. doi: 10.1002/1097-0142(19950901)76:53.0.co;2-r.
Results Reference
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Biological Therapy in Treating Patients With Primary or Advanced Glioma

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