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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Roberta L. Hayes, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Immune Therapy, LLC

Authority:

United States: Federal Government

Study ID:

CDR0000065739

NCT ID:

NCT00003067

Start Date:

July 1997

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult mixed glioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Staten Island University HospitalStaten Island, New York  10305