Biological Therapy in Treating Patients With Primary or Advanced Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00003067
• Other study ID #: CDR0000065739
• Secondary ID: NYWCCC-0902499NY
• Status: Suspended
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 6, 2009
• Start date: July 1997

Study information

• Verified date: October 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Biological:
• aldesleukin

• lymphokine-activated killer cells

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 gliom — View Citation