NCT00911560Befejeződött1/2. fázis
Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma
Phase I/II Trial of a Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 5.
Rövid összefoglaló (regiszter, angolul)
In the first part of this study we found the highest dose of the vaccine that did not have too many side effects. We are now trying to find out what effects the vaccine has when given at the same dose to all patients. The main treatment in this protocol is a vaccine. It is called a " bivalent vaccine" which means it has 2 antigens. An antigen is a specific protein on the surface of a cell. The antigens are called GD2L and GD3L. We want the vaccine to cause the patient's immune system to make antibodies against the antigens. Antibodies are made by the body to attack cancer (and to fight infections). If the patient can make antibodies against the 2 antigens in the vaccine, those antibodies might also attach to neuroblastoma cells because a lot of each antigen is on neuroblastoma (and very little on other parts of the body). Then, the attached antibodies would attract the patient's white blood cells to kill the neuroblastoma. This protocol also uses β-glucan which is a kind of sugar from yeast. β-glucan is taken by mouth and can help white blood cells kill cancer. The best way to get the body to make antibodies against the 2 antigens is to link each antigen to a protein called KLH (which stands for: keyhole limpet hemocyanin) and to mix them with a substance called QS-21. But it is hard to get enough QS-21 so we are using an identical substance called OPT-821, which we can get easily in large amounts for use in patients.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 374 (tényleges)
- Első benyújtás
- 2009. máj. 29.
- Kezdés
- 2009. máj. 27.
- Elsődleges befejezés
- 2026. aug. 3.
- Fő szponzor
- Memorial Sloan Kettering Cancer Center
- Betegségek
- Neuroblasztóma, Gyermekkori daganatok
- NCT-szám
- NCT00911560
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Bevont résztvevők: 374
- 2009. máj. 27. és az elsődleges befejezés (2026. aug. 3.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Más betegség
- History of allergy to KLH, QS-21, OPT-821, or glucan.
- Active life-threatening infection.
Egyéb
- Inability to comply with protocol requirements.
Kiket keres a vizsgálat
- Diagnosis of neuroblastoma (NB) as defined by international criteria,\[104\] i.e., histopathology (confirmed by the MSKCC Department of Pathology) or bone marrow metastases plus high urine catecholamine levels.
- High-risk NB as defined by risk-related treatment guidelines and the International NB Staging System,\[104\] i.e., stage 4 with MYCN amplification (any age) stage 4 \>18 months old.
- High-risk NB (as defined above) and in 1) first CR at 6 ≥ months from initiation of immunotherapy using anti-GD2 antibody, or 2) second or subsequent remission. Remission is defined as complete (CR) remission, according to the International Neuroblastoma Response Criteria.\[104\] Urine catecholamine levels are no longer taken into consideration when staging.
- Absolute lymphocyte count ≥ 500/mcl and absolute neutrophil count ≥ 500/mcl.
- Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 3.0) developed by the National Cancer Institute of the USA (CTCAE v3.0) related to cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam.
- ALT, AST and Alkaline Phosphatase ≤ 2.5 times the upper limit of normal
- Prior treatment with other immunotherapy, including antibodies, is allowed
- ≥ 3 weeks and no more than 6 months (\<180 days) between completion of systemic therapy and 1st vaccination.
- Patients previously enrolled on this trial are eligible for repeat enrollment but will be assigned to treatment as per the control arm (Group 1) and will not be included in the biostatistical analyses.
- Signed informed consent indicating awareness of the investigational nature of this program.
Életkor a regiszterben: - – 21 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
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| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | New York | Egyesült Államok | Ismeretlen állapot |
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