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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

Robert O. Dillman, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian

Authority:

Unspecified

Study ID:

CDR0000630437

NCT ID:

NCT00814593

Start Date:

November 2008

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult glioblastoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Hoag Cancer Institute at Hoag Memorial Hospital PresbyterianNewport Beach, California  92663