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 range

0 Years – 120 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.

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 …

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

Toxicity

Timeframe: 2 years

Trial details

NCT IDNCT00492167

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-04

View on ClinicalTrials.gov More Neuroblastoma trials