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

This study has been terminated.
(Hoag Hospital ceased support.)
Sponsor:
Information provided by (Responsible Party):
NeoStem, Inc.
ClinicalTrials.gov Identifier:
NCT00814593
First received: December 24, 2008
Last updated: June 30, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 NeoStem, Inc.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 5 years or death, whichever came first. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of significant surgical wound infection (grade 3 or 4) [ Time Frame: 4 weeks from date of study treatment. ] [ Designated as safety issue: No ]
  • Rate of grade 3 or 4 non-infectious wound complications [ Time Frame: 4 weeks from date of study treatment. ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE version 3.0 [ Time Frame: 4 weeks from date of study treatment. ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: November 2008
Study Completion Date: September 2011
Primary Completion Date: April 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814593

Locations
United States, California
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Sponsors and Collaborators
NeoStem, Inc.
Investigators
Principal Investigator: Robert O. Dillman, MD, FACP NeoStem, Inc.
  More Information

No publications provided

Responsible Party: NeoStem, Inc.
ClinicalTrials.gov Identifier: NCT00814593     History of Changes
Other Study ID Numbers: CDR0000630437, HOAG-HCC-08-01
Study First Received: December 24, 2008
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NeoStem, Inc.:
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 August 21, 2014