Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	WSU-C-1403-BT NCI-G99-1567, NCT00004024

Objectives

1. 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.
2. Determine the immunogenicity of malignant gliomas in patients treated with this regimen.

Entry 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

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

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/mm³
• 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

Expected Enrollment

A total of 60 patients will be accrued for this study.

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.

Sloan AE, Dansey R, Zamorano L, et al.: 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. Neurosurgical Focus 9(6): 1-8, 2000.

Trial Contact Information

Trial Lead Organizations

Barbara Ann Karmanos Cancer Institute

Andrew Sloan, MD, Protocol chair(Contact information may not be current)		Ph: 313-966-5007; 800-527-6266

Registry Information
Official Title		Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy
Trial Start Date		1997-06-07
Registered in ClinicalTrials.gov		NCT00004024 1
Date Submitted to PDQ		1999-07-30
Information Last Verified		2004-11-18
NCI Grant/Contract Number		P30-CA22453

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00004024