Clinical trial · Interventional
Lymphokine-Activated Killer Cells or Gliadel Wafer in Treating Patients With Newly Diagnosed Glioblastoma Multiforme That Can Be Removed by Surgery
Randomized Phase II Trial of Intralesional Lymphokine Activated Killer Cells or Polifeprosan 20 With Carmustine Implant (Gliadel® Wafer) as Consolidation Therapy After Primary Treatment of Newly Diagnosed Resectable Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Hoag Hospital ceased support.
Summary
Brief summary (as posted)
RATIONALE: Biological therapies, such as lymphokine-activated killer cells, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as Gliadel wafer, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether lymphokine-activated killer cells are more effective than Gliadel wafer in treating patients with glioblastoma multiforme. PURPOSE: This randomized phase II trial is studying the side effects and how well lymphokine-activated killer cells work compared with Gliadel wafer in treating patients with newly diagnosed glioblastoma multiforme that can be removed by surgery.
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 |
|---|---|---|---|
| lymphokine-activated killer cells | Biological | — | UNRESOLVED |
| polifeprosan 20 with carmustine implant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy.
- interventionNames
- Drug: polifeprosan 20 with carmustine implant
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo leukapheresis to obtain autologous lymphokine-activated killer (LAK) cells, followed 3-7 days later by therapeutic craniotomy. The autologous LAK cells are then instilled into the tumor bed cavity at the time of therapeutic craniotomy.
- interventionNames
- Biological: lymphokine-activated killer cells
Primary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary malignant glioblastoma multiforme (GBM) (i.e., grade IV anaplastic astrocytoma) * Must have undergone standard primary therapy (e.g., surgery, radiotherapy, and temozolomide) within the past 90 days * Additional anticancer therapy as part of first-line therapy, including a radiosurgical procedure (e.g., stereotactic or gamma knife radiosurgery) allowed * Must be an operable candidate and willing to undergo craniotomy PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Life expectancy ≥ 2 months * Hemoglobin \> 10.0 g/dL * AGC \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Serum total bilirubin \< 1.5 times upper limit of normal (ULN) * ALT and AST \< 2.5 times ULN * Serum creatinine \< 1.5 times ULN * Negative pregnancy test * Resides in the United States of America * Venous access available for leukapheresis procedure to obtain peripheral blood mononuclear cells * No diagnosis of any other invasive cancer within the past 5 years, except in situ carcinoma or basal cell carcinoma or localized squamous cell carcinoma of the skin * Patients with prior diagnosis of minimal microscopic cancer (e.g., colonic polyp or stage I prostate cancer with Gleason score \< 6) may be eligible, as determined by the principal investigator * No concurrent serious medical or psychiatric illness that may interfere with giving informed consent or conducting this study * No known hypersensitivity or allergy to either carmustine or aldesleukin PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 weeks since prior anticancer therapy and recovered * No polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of prior surgery for GBM * No prior treatment for progressive disease * No other concurrent anticancer therapy (e.g., continuation of hormonal therapy for breast or prostate cancer that was diagnosed \> 5 years ago)
References
Publications (0)
Data not yet available