Lymphokine-Activated Killer Cells or Gliadel Wafer in Treating Patients With Newly Diagnosed Glioblastoma Multiforme That Can Be Removed by Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00814593
First received: December 24, 2008
Last updated: September 27, 2011
Last verified: June 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: lymphokine-activated killer cells Drug: polifeprosan 20 with carmustine implant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
- Rate of significant surgical wound infection (grade 3 or 4) [ Designated as safety issue: No ]
- Rate of grade 3 or 4 non-infectious wound complications [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy.
|
Drug: polifeprosan 20 with carmustine implant
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.
|
Biological: lymphokine-activated killer cells
Instilled into the tumor bed cavity
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814593
Locations
| United States, California | |
| Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian | Recruiting |
| Newport Beach, California, United States, 92663 | |
| Contact: Clinical Trials Office - Hoag Cancer Institute 949-764-5543 | |
Sponsors and Collaborators
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
Investigators
| Principal Investigator: | Robert O. Dillman, MD, FACP | Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian |
More Information
Additional Information:
No publications provided
| Responsible Party: | Robert O. Dillman, Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian |
| ClinicalTrials.gov Identifier: | NCT00814593 History of Changes |
| Other Study ID Numbers: | CDR0000630437, HOAG-HCC-08-01 |
| Study First Received: | December 24, 2008 |
| Last Updated: | September 27, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adult giant cell glioblastoma adult gliosarcoma adult glioblastoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Carmustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013