Biological Therapy in Treating Patients With Primary or Advanced Glioma

NCT ID: NCT00003067

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-07-31

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

lymphokine-activated killer cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Principal Investigators

Roberta L. Hayes, PhD

Role: STUDY_CHAIR

Immune Therapy, LLC

Locations

Staten Island University Hospital

Staten Island, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 8625188 (View on PubMed)

Other Identifiers

NYWCCC-0902499

Identifier Type: -

Identifier Source: secondary_id

NYWCCC-IMMUNE-0902499

Identifier Type: -

Identifier Source: secondary_id

SIUH-RP-96-004

Identifier Type: -

Identifier Source: secondary_id

NCI-V97-1326

Identifier Type: -

Identifier Source: secondary_id

CDR0000065739

Identifier Type: -

Identifier Source: org_study_id