Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma (NCT00107185) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma
United States7 participantsStarted 2005-01
Plain-language 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 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.
Who can participate
Age range1 Year – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 vaccin…
What they're measuring
1
Dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma.