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Clinical Trials (PDQ®)

Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral ß-glucan for High-Risk Neuroblastoma

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase ITreatmentActive21 and underOther05-075
NCT00911560

Trial Description

Summary

The purpose of this study is to test the safety and what effects, good and/or bad, treatment with a vaccine against neuroblastoma has on the patient and the cancer. 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 3 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.

Eligibility Criteria

Inclusion Criteria:

  • 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 (any age) or without (>18 months old) MYCN amplification, MYCN-amplified stage 3 (unresectable; any age), MYCN-amplified stage 4S, or disease resistant to standard chemotherapy.
  • Relapsed high-risk NB (as defined above) and now in second or subsequent remission. Remission is defined as complete (CR) or very good partial (VGPR)remission, according to the International Neuroblastoma Response Criteria.[104] Urine catecholamine levels are no longer taken into consideration when staging.

Patients can be considered as in VGPR with 1 or 2 MIBG (+) sites that were previously- irradiated.

  • Absolute lymphocyte count > or = to 500/mcl and absolute neutrophil count > or = to 500/mcl.
  • Creatinine ≤ 2.0 mg/dL
  • ALT, AST and Alkaline Phosphatase ≤ 2.5 times the upper limit of normal
  • Bilirubin ≤ 2.0 mg/dL
  • Patients with less than grade 3 toxicities (using the CTCAE v3.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam.
  • Prior treatment with other immunotherapy, including antibodies, is allowed
  • > or = to 3 weeks between completion of systemic therapy and 1st vaccination.
  • Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria:

  • History of allergy to KLH, QS-21, OPT-821, or glucan.
  • Active life-threatening infection.
  • Inability to comply with protocol requirements.

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

Brian H. KushnerPrincipal Investigator

Brian Kushner, MDPh: 212-639-6793

Trial Sites

U.S.A.
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 Brian Kushner, MD Ph: 212-639-6793
 Brian H. KushnerPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00911560
ClinicalTrials.gov processed this data on May 21, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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