Status:
COMPLETED
Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant g...
Eligibility Criteria
Inclusion
- 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
- Syphilis negative
- At least 2 weeks since prior radiotherapy and recovered
- Negative pregnancy test
- Fertile patients must use effective contraception
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No chemotherapy during and for 4 weeks\* after the final dose of study vaccine
- No corticosteroids for at least 10 days before leukapheresis
- No concurrent corticosteroids
- More than 72 hours since prior systemic antibiotics
- No antihistamines for 5 days before and for 5 days after administration of study vaccine
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00107185
Start Date
January 1 2005
End Date
March 1 2010
Last Update
August 5 2020
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781