Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: aldesleukin Biological: autologous tumor cell vaccine Biological: muromonab-CD3 Biological: sargramostim Biological: therapeutic autologous lymphocytes Procedure: surgical procedure Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 1997 |
| Study Completion Date: | January 2004 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Study Chair: | Andrew E. Sloan, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00004024 History of Changes |
| Other Study ID Numbers: | CDR0000067243, P30CA022453, WSU-C-1403-BT, NCI-G99-1567 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
|
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 |
Additional relevant MeSH terms:
|
Astrocytoma Nervous System Neoplasms Oligodendroglioma Central Nervous System Neoplasms Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site |
Nervous System Diseases Muromonab-CD3 Aldesleukin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Antineoplastic Agents Therapeutic Uses Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 18, 2013