or
forgot password

Adoptive Immunotherapy of Glioblastoma Multiforme With Tumor-Sensitized, Ex Vivo Activated T Lymphocytes


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

Thank you

Trial Information

Adoptive Immunotherapy of Glioblastoma Multiforme With Tumor-Sensitized, Ex Vivo Activated T Lymphocytes


OBJECTIVES: I. Determine the time to progression in patients with glioblastoma multiforme or
anaplastic astrocytoma (primary presentation) treated with surgical resection, radiotherapy,
and T cell immunotherapy as initial therapy. II. Determine the toxic effects of this therapy
in these patients.

OUTLINE: Patients are vaccinated with irradiated, autologous tumor cells plus sargramostim
(GM-CSF) intradermally near draining lymph nodes in the groin or axillary regions. This is
then followed by 3 consecutive days of intradermal injections of GM-CSF only, directly into
the vaccine sites. Enlarged lymph nodes are then removed 7-10 days later and activated with
staphylococcal enterotoxin A (SEA) and interleukin-2 (IL-2). T cells are expanded ex vivo
over approximately 10 days. 1-2 days prior to infusion, oral cyclophosphamide is
administered as a one time dose. The lymphocyte infusion is then administered intravenously.
Based on availability, patients may receive vaccine boosts with additional injections of
irradiated autologous tumor cells thawed from the original, cryopreserved collection.
Patients are followed at 1 month and then every 2 months thereafter.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven glioblastoma multiforme or anaplastic
astrocytoma Prior surgical resection and radiotherapy completed approximately 1 month
prior to study

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 OR Karnofsky 70-100%
Life expectancy: Not specified Hematopoietic: WBC greater than 2000/mm3 Platelet count
greater than 100,000/mm3 Hepatic: No active infection with hepatitis B Renal: Not
specified Other: Not pregnant or nursing Fertile patients must use effective contraception
during and for 1 month after study No active collagen vascular or autoimmune disease No
prior severe reaction to any blood product No other prior malignancy within the past 5
years except adequately treated squamous cell or basal cell skin cancer, carcinoma in situ
or the cervix, or stage I or II cancer in complete remission Not immunologically
compromised due to chronic conditions Not allergic by standard skin testing HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy with
immunomodulatory effects (e.g., interleukin-2, interferon alfa) Chemotherapy: No prior or
concurrent local or systemic chemotherapy Endocrine therapy: At least 1 week since prior
corticosteroid therapy No concurrent corticosteroid therapy Radiotherapy: See Disease
Characteristics Surgery: See Disease Characteristics Other: No concurrent
antiproliferatives or immunosuppressants

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Suyu Shu, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000066013

NCT ID:

NCT00003185

Start Date:

August 1997

Completion Date:

Related Keywords:

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

Name

Location
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195