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

Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00004024
Enrollment
60
Registered
2003-01-27
Start date
1997-06-30
Completion date
2004-01-31
Last updated
2013-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BIOLOGICALaldesleukin
BIOLOGICALautologous tumor cell vaccine
BIOLOGICALmuromonab-CD3
BIOLOGICALsargramostim
BIOLOGICALtherapeutic autologous lymphocytes
PROCEDUREsurgical procedure
RADIATIONradiation therapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Barbara Ann Karmanos Cancer Institute
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026