- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00814593
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Newport Beach, California, United States, 92663
- Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy.
|
Intracranial placement
|
Experimental: 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.
|
Instilled into the tumor bed cavity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 5 years or death, whichever came first.
|
5 years or death, whichever came first.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of significant surgical wound infection (grade 3 or 4)
Time Frame: 4 weeks from date of study treatment.
|
4 weeks from date of study treatment.
|
Rate of grade 3 or 4 non-infectious wound complications
Time Frame: 4 weeks from date of study treatment.
|
4 weeks from date of study treatment.
|
Toxicity as assessed by NCI CTCAE version 3.0
Time Frame: 4 weeks from date of study treatment.
|
4 weeks from date of study treatment.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert O. Dillman, MD, FACP, Caladrius Biosciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Carmustine
Other Study ID Numbers
- CDR0000630437
- HOAG-HCC-08-01 (Other Identifier: Hoag Cancer Center at Hoag Memorial Hospital Presbyterian)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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