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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lymphokine-activated killer cells
polifeprosan 20 with carmustine implant
Sponsored by
Lisata Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy.

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.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Rate of significant surgical wound infection (grade 3 or 4)
Rate of grade 3 or 4 non-infectious wound complications
Toxicity as assessed by NCI CTCAE version 3.0

Full Information

First Posted
December 24, 2008
Last Updated
May 9, 2019
Sponsor
Lisata Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00814593
Brief Title
Lymphokine-Activated Killer Cells or Gliadel Wafer in Treating Patients With Newly Diagnosed Glioblastoma Multiforme That Can Be Removed by Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Hoag Hospital ceased support.
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lisata Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
lymphokine-activated killer cells
Intervention Description
Instilled into the tumor bed cavity
Intervention Type
Drug
Intervention Name(s)
polifeprosan 20 with carmustine implant
Intervention Description
Intracranial placement
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years or death, whichever came first.
Secondary Outcome Measure Information:
Title
Rate of significant surgical wound infection (grade 3 or 4)
Time Frame
4 weeks from date of study treatment.
Title
Rate of grade 3 or 4 non-infectious wound complications
Time Frame
4 weeks from date of study treatment.
Title
Toxicity as assessed by NCI CTCAE version 3.0
Time Frame
4 weeks from date of study treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert O. Dillman, MD, FACP
Organizational Affiliation
Caladrius Biosciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States

12. IPD Sharing Statement

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

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