Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma

Completed · Phase 1

Conditions studied: Brain and Central Nervous System Tumors

In brief

RATIONALE: Vaccines made from a person's white blood cells and tumor cells may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy after surgery may be a more effective treatment for malignant glioma. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating young patients who are undergoing surgery for malignant glioma.

Key facts

Study ID

NCT00107185

Run by

Jonsson Comprehensive Cancer Center

People needed

7

Starts

2005-01-01

Expected to finish

2010-03-01

Last updated by the study team

2020-08-05

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed* WHO grade III or IV malignant glioma of 1 of the following subtypes:
• Anaplastic astrocytoma
• Anaplastic oligodendroglioma
• Glioblastoma multiforme NOTE: *Must be confirmed after surgery
• Newly diagnosed OR recurrent disease
• Bidimensionally measurable disease by contrast-enhancing pre-operative MRI
• Surgically accessible tumor for which surgical resection is indicated at the time of initial pre-operative evaluation
• Must have undergone standard surgery* AND either radiotherapy* or chemoradiotherapy*
• Objective evidence of disease by contrast-enhanced brain MRI after completion of standard therapy NOTE: *Completed after study entry but before assignment to study treatment cohorts
• Age 1 to 18
• Performance status Karnofsky 60-100%
• Hematopoietic
• Hemoglobin ≥ 10 g/dL
• Absolute granulocyte count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hepatic
• SGPT and SGOT ≤ 2 times normal
• Alkaline phosphatase ≤ 2 times normal
• Bilirubin ≤ 1.5 mg/dL
• Hepatitis B and C negative
• Renal
• BUN ≤ 1.5 times normal OR
• Creatinine ≤ 1.5 times normal
• Immunologic
• HIV negative

You may not qualify if…

• history of immunodeficiency or autoimmune disease that may be exacerbated by immunotherapy, including any of the following:
• Rheumatoid arthritis
• Systemic lupus erythematosus
• Vasculitis
• Polymyositis
• Dermatomyositis
• Scleroderma
• Multiple sclerosis
• Juvenile-onset insulin-dependent diabetes
• active infection
• fever
• allergy to study reagents
• pregnant or nursing
• other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, localized prostate cancer, or carcinoma in situ of the cervix
• unstable or severe medical or psychiatric condition, as determined by the investigator
• underlying condition that would preclude study participation
• concurrent radiotherapy
• prior organ allograft
• concurrent strong painkillers
• other concurrent immune-suppressing medications
• other concurrent investigational agents
• other adjuvant treatment for 4 weeks* after the final dose of study vaccine NOTE: *Unless there is evidence of tumor progression necessitating additional clinically-indicated treatment; patients requiring treatment due to tumor progression are removed from the study

Where it is running

• Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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