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Biological Therapy in Treating Patients With Primary or Advanced Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00003067
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Weill Medical College of Cornell University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Roberta L. Hayes, PhD
Principal Investigator Affiliation Immune Therapy, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Suspended
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Staten Island University Hospital, Staten Island, New York

Status

Address

Staten Island University Hospital

Staten Island, New York, 10305

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