Clinical trial · Interventional
Biological Therapy in Treating Patients With Primary or Advanced Glioma
Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas
NCT00003067CI-TRIAL-00001993suspendedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| lymphokine-activated killer cells | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTHayes 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. PMID 8625188