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 range

1 Year – 18 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma.

Timeframe: 1 year

Trial details

NCT IDNCT00107185

SponsorJonsson Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-10

View on ClinicalTrials.gov More Brain and Central Nervous System Tumors trials