Beta-Glucan and Monoclonal Antibody 3F8 in Treating Patients With Metastatic Neuroblastoma (NCT00492167) | Clinical Trial Compass
CompletedPhase 1
Beta-Glucan and Monoclonal Antibody 3F8 in Treating Patients With Metastatic Neuroblastoma
United States45 participantsStarted 2005-09-09
Plain-language summary
RATIONALE: Beta-glucan may stimulate the immune system and stop tumor cells from growing. Monoclonal antibodies, such as 3F8, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving beta-glucan together with monoclonal antibody 3F8 may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan when given together with monoclonal antibody 3F8 in treating patients with metastatic neuroblastoma.
Who can participate
Age range0 Years – 120 Years
SexALL
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DISEASE CHARACTERISTICS:
* Diagnosis of neuroblastoma by 1 of the following methods:
* Histopathology
* Bone marrow involvement AND elevated urinary catecholamines
* High-risk disease, defined by 1 of the following:
* Stage 4 disease with MYCN amplification (any age) or without MYCN amplification (\> 18 months of age)
* MYCN-amplified stage 3 disease (unresectable and any age)
* MYCN-amplified stage 4S disease
* Metastatic disease
* Tumor progression or persistent disease (at metastatic or primary site) after intensive conventional chemotherapy
* Must have evaluable (microscopic marrow metastasis, elevated tumor markers, positive MIBG or PET scans) or measurable (CT scan or MRI) disease documented after completion of prior systemic therapy
PATIENT CHARACTERISTICS:
* Platelet count \> 25,000/mm\^3
* ANC \> 500/mm\^3
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of allergy to mouse proteins, beta-glucan, mushrooms, or yeast
* No active life-threatening infections
* No severe major organ toxicity
* Concurrent toxicity must be ≤ grade 2 except for the following, which may be grade 3:
* Myelosuppression
* Hearing loss
* Alopecia
* Anorexia
* Nausea
* Hyperbilirubinemia from TPN
* Anxiety
* Hypomagnesemia
* No prior HAMA titer \> 1,000 U/mL by ELISA
PRIOR CONCURRENT THERAPY:
* No concurrent supplemental beta-glucan in food (e.g., bran cereals or mushrooms) or …