Biological Therapy in Treating Patients With Glioblastoma Multiforme

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003185
First received: November 1, 1999
Last updated: December 3, 2013
Last verified: December 2008
  Purpose

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients with glioblastoma multiforme.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: autologous tumor cell vaccine
Biological: sargramostim
Biological: tumor-draining lymph node lymphocyte therapy
Drug: cyclophosphamide
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Adoptive Immunotherapy of Glioblastoma Multiforme With Tumor-Sensitized, Ex Vivo Activated T Lymphocytes

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: August 1997
Study Completion Date: July 1998
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  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: NCT00003185

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: Suyu Shu, PhD The Cleveland Clinic
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003185     History of Changes
Other Study ID Numbers: CDR0000066013, CCF-BB-IND-6154, NCI-H98-0008
Study First Received: November 1, 1999
Last Updated: December 3, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma

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
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on July 29, 2014