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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004024
• Other study ID #: CDR0000067243
• Secondary ID: P30CA022453WSU-C
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: April 3, 2013
• Start date: June 1997
• Est. completion date: January 2004

Study information

• Verified date: April 2013
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00004018
• NCT00004019
• NCT00004020
• NCT00004021
• NCT00004023

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Biological:
• aldesleukin

• autologous tumor cell vaccine

• muromonab-CD3

• sargramostim

• therapeutic autologous lymphocytes

Procedure:
• surgical procedure

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sloan AE, Dansey R, Zamorano L, Barger G, Hamm C, Diaz F, Baynes R, Wood G. Adoptive immunotherapy in patients with recurrent malignant glioma: preliminary results of using autologous whole-tumor vaccine plus granulocyte-macrophage colony-stimulating fact — View Citation