Status:
WITHDRAWN
Lymphokine-Activated Killer Cells or Gliadel Wafer in Treating Patients With Newly Diagnosed Glioblastoma Multiforme That Can Be Removed by Surgery
Lead Sponsor:
Lisata Therapeutics, Inc.
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Gli...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00814593
Start Date
November 1 2008
End Date
September 1 2011
Last Update
May 10 2019
Active Locations (1)
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1
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663