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Biological Therapy in Treating Patients With Primary or Advanced Glioma

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status and phase

Suspended
Phase 2

Conditions

Brain and Central Nervous System Tumors

Treatments

Biological: aldesleukin
Biological: lymphokine-activated killer cells

Study type

Interventional

Funder types

Other

Identifiers

NCT00003067
CDR0000065739
NYWCCC-IMMUNE-0902499
NCI-V97-1326
SIUH-RP-96-004
NYWCCC-0902499

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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