Clinical trial NCT00003067: 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
Overall status: SUSPENDED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Immune Therapy, LLC
name: Roberta L. Hayes, PhD
role: STUDY_CHAIR
References:
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.