search
Back to results

Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
autologous tumor cell vaccine
muromonab-CD3
sargramostim
therapeutic autologous lymphocytes
surgical procedure
radiation therapy
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult subependymoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult diffuse astrocytoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven grade II, III, or IV astrocytoma or oligodendroglioma Evidence of primary or recurrent tumor by MRI Resectable disease At least 20,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0 or 1 Life expectancy: At least 6 months Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least lower limit of normal No active or recent uncontrolled bleeding Hepatic: Bilirubin normal SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Renal: Creatinine normal Other: Able to be weaned off steroids Negative stool guaiac No impaired immunity No uncontrolled diabetes No active uncontrolled infections No other serious disease No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix No psychological, familial, sociological, or geographical conditions that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy except for progressive disease Endocrine therapy: See Disease Characteristics Radiotherapy: Radium implants allowed Surgery: Not specified Other At least 1 week since prior therapy and recovered

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
April 3, 2013
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00004024
Brief Title
Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
Official Title
Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 1997 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery and radiation therapy in treating patients who have primary or recurrent astrocytoma or oligodendroglioma.
Detailed Description
OBJECTIVES: Determine the efficacy of immunotherapy with irradiated autologous tumor cell vaccine and adoptive immunotherapy, in terms of time to progression and median and one-year survival, in patients with primary or recurrent malignant astrocytoma or oligodendroglioma. Determine the immunogenicity of malignant gliomas in patients treated with this regimen. OUTLINE: Patients are stratified according to extent of disease, extent of antigen-specific response to vaccination, performance status (0 vs 1), prior therapy (yes vs no), and gender. Patients undergo tumor resection on week 1. Patients without recurrent disease receive local radiotherapy on weeks 2-8. Beginning week 10-12, patients are vaccinated with irradiated autologous tumor cells and sargramostim (GM-CSF) and then receive GM-CSF alone intradermally at vaccination sites daily for 4 days. Patients are revaccinated 4 weeks later and may receive up to 3 additional vaccinations every 2 weeks until a response is detected. Patients undergo peripheral blood mononuclear cell collection on week 14 followed by monoclonal antibody OKT3-activated T lymphocytes IV over 1-6 hours with alternating interleukin-2 IV once every other day for 5 doses over 10 days beginning on week 16. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive one additional course of immunotherapy as above. Patients are followed at 1 week, monthly for 3 months, every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

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
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult subependymoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult diffuse astrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
autologous tumor cell vaccine
Intervention Type
Biological
Intervention Name(s)
muromonab-CD3
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous lymphocytes
Intervention Type
Procedure
Intervention Name(s)
surgical procedure
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven grade II, III, or IV astrocytoma or oligodendroglioma Evidence of primary or recurrent tumor by MRI Resectable disease At least 20,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0 or 1 Life expectancy: At least 6 months Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least lower limit of normal No active or recent uncontrolled bleeding Hepatic: Bilirubin normal SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Renal: Creatinine normal Other: Able to be weaned off steroids Negative stool guaiac No impaired immunity No uncontrolled diabetes No active uncontrolled infections No other serious disease No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix No psychological, familial, sociological, or geographical conditions that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy except for progressive disease Endocrine therapy: See Disease Characteristics Radiotherapy: Radium implants allowed Surgery: Not specified Other At least 1 week since prior therapy and recovered
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew E. Sloan, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16817692
Citation
Sloan AE, Dansey R, Zamorano L, Barger G, Hamm C, Diaz F, Baynes R, Wood G. Adoptive immunotherapy in patients with recurrent malignant glioma: preliminary results of using autologous whole-tumor vaccine plus granulocyte-macrophage colony-stimulating factor and adoptive transfer of anti-CD3-activated lymphocytes. Neurosurg Focus. 2000 Dec 15;9(6):e9. doi: 10.3171/foc.2000.9.6.10.
Results Reference
result

Learn more about this trial

Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma

We'll reach out to this number within 24 hrs