Lymphokine-Activated Killer Cells or Gliadel Wafer in Treating Patients With Newly Diagnosed Glioblastoma Multiforme That Can Be Removed by Surgery - Full Text View

Sponsor:	Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00814593

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 II

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:

MedlinePlus related topics: Cancer

Drug Information available for: Polifeprosan 20 Carmustine

U.S. FDA Resources

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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 February 09, 2012