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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
| City: |
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Newport Beach |
| State: |
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California |
| Zip Code: |
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92663 |
| Conditions: |
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Brain and Central Nervous System Tumors |
| Purpose: |
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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.
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| Study Summary: |
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OBJECTIVES:
- To compare the side effects, including infections and/or abnormal healing at the
surgery site, associated with intralesional lymphokine-activated killer (LAK) cells vs
polifeprosan 20 with carmustine implant (Gliadel® wafer) as consolidation therapy for
patients with newly diagnosed resectable glioblastoma multiforme.
- To compare the overall survival of patients treated with these regimens.
OUTLINE: Patients are stratified according to age (< 50 vs ≥ 50 years of age), Karnofsky
performance status (70-80% vs 90-100%), use of corticosteroids > 4 mg/day (yes vs no), and
progressive disease during first-line therapy (yes vs no). Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients undergo intracranial placement of polifeprosan 20 with carmustine
implant (Gliadel® wafer) at the time of therapeutic craniotomy.
- Arm II: 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.
After completion of study treatment, patients are followed periodically for up to 5 years.
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| Criteria: |
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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)
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| NCT ID: |
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NCT00814593 |
| Primary Contact: |
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Principal Investigator
Robert O. Dillman, MD, FACP
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
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| Backup Contact: |
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N/A |
| Location Contact: |
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Newport Beach, California 92663
United States
Clinical Trials Office - Hoag Cancer Institute
Phone: 949-764-5543
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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