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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Andrew E. Sloan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067243

NCT ID:

NCT00004024

Start Date:

June 1997

Completion Date:

January 2004

Related Keywords:

  • Brain and Central Nervous System Tumors
  • 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
  • Astrocytoma
  • Nervous System Neoplasms
  • Oligodendroglioma
  • Central Nervous System Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201