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Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes


Phase 2
16 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes


OBJECTIVES:

- Determine the feasibility, side effects, and toxicity associated with intracranial
cellular adoptive immunotherapy comprising aldesleukin-stimulated lymphokine-activated
killer cells in patients with glioblastoma multiforme.

- Determine progression-free and overall survival of these patients.

- Compare survival of these patients to that of contemporary and historical controls.

OUTLINE: Patients undergo therapeutic craniotomy.

Patients undergo leukapheresis to obtain lymphokine-activated killer (LAK) cells 3-7 days
before therapeutic craniotomy OR 4-6 weeks after therapeutic craniotomy. Patients receive
cellular adoptive immunotherapy comprising aldesleukin-stimulated LAK cells intracranially
at the time of therapeutic craniotomy OR via an Ommaya reservoir (placed during craniotomy)
no sooner than 4-6 weeks after therapeutic craniotomy.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of primary malignant glioblastoma multiforme (i.e., grade IV anaplastic
astrocytoma)

- Primary treatment (surgery, radiation, and/or chemotherapy) has been completed

- Candidate for surgery and willing to undergo craniotomy

- No progressive or recurrent disease

- No residual disease that requires reoperation, additional gamma therapy, or other
modality

PATIENT CHARACTERISTICS:

- ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100% (i.e., if symptomatic,
bedridden < half of a waking day)

- Life expectancy ≥ 2 months

- Not pregnant

- Negative pregnancy test

- U.S. residents only

- No hematopoietic, hepatic, renal, cardiovascular, or pulmonary laboratory values or
other medical circumstances that would preclude surgery or aldesleukin therapy

- No serious concurrent medical or psychiatric illness that would preclude informed
consent or study treatment

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 4 weeks since prior anticancer therapy and recovered

- Prior stereotactic or gamma knife radiosurgery allowed

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Side effects and toxicity

Safety Issue:

Yes

Principal Investigator

Robert O. Dillman, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000471241

NCT ID:

NCT00331526

Start Date:

February 1999

Completion Date:

April 2012

Related Keywords:

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

Name

Location

Hoag Cancer Center at Hoag Memorial Hospital Presbyterian Newport Beach, California  92663