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
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
- 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
- Determine the immunogenicity of malignant gliomas in patients treated with this
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.
- 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
- 18 and over
- SWOG 0 or 1
- At least 6 months
- Granulocyte count at least 1,500/mm^3
- Platelet count at least lower limit of normal
- No active or recent uncontrolled bleeding
- Bilirubin normal
- SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver
metastases are present)
- Creatinine normal
- 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
PRIOR CONCURRENT THERAPY:
- Not specified
- No concurrent chemotherapy except for progressive disease
- See Disease Characteristics
- Radium implants allowed
- Not specified
- At least 1 week since prior therapy and recovered