Neuroblastoma Vaccine for Treatment of High-Risk Neuroblastoma After Chemotherapy

NCT00048386 | Completed Phase 1 DMC

• 2 other identifiers: H8354HIGH RISK NEUROBLASTOMA
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

PRIMARY OBJECTIVE To determine the percentage of patients with high risk neuroblastoma in first or subsequent partial response or better, or with microscopic residual bone marrow disease, who demonstrate an immunological anti-tumor response at any time during, and for up to 12 months from initiation of, treatment with subcutaneous injections of autologous neuroblastoma cells, genetically modified by adenoviral vectors to secrete interleukin-2 (IL-2) (autologous neuroblastoma vaccine) SECONDARY OBJECTIVES 1. To determine the toxicity of the autologous neuroblastoma vaccine given according to this schedule 2. To obtain preliminary data on the effect of vaccine administration on progression-free survival from high-risk neuroblastoma

Conditions

Neuroblastoma

Outcome Measures

Primary Outcomes (1)

• Patients who demonstrate immunological anti-tumor response at any time during, and for up to 12 months from initiation of, treatment with injections of autologous neuroblastoma cells, genetically modified by adenoviral vectors to secrete IL-2

  12 months post injections

Secondary Outcomes (2)

• To determine the toxicity of the autologous neuroblastoma vaccine given according to this schedule

  15 years

• To obtain preliminary data on progression-free survival from high-risk neuroblastoma following vaccine administration

  15 years

Interventions

autologous neuroblastoma vaccine BIOLOGICAL

A vaccine dose of 0.3 x 108 IL-2 secreting cells/patient/injection will be used. Injections will be given twice monthly for two months, then monthly for four months, for a total of eight vaccine injections over six months.

Eligibility Criteria

• Age: Up to 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with high risk neuroblastoma defined below, who, following completion of front-line or salvage chemotherapy that may or may not have included high-dose chemotherapy followed by peripheral blood stem cell or bone marrow rescue with or without cis-retinoic acid, have achieved partial response or better, or who have microscopic residual bone marrow:
• INSS Stage 4 neuroblastoma, diagnosed between 1 and 21 years of age (inclusive)
• INSS Stage 3, N-myc amplified neuroblastoma, diagnosed between 1 and 21 years of age (inclusive)
• INSS Stage 3, N-myc non-amplified, Shimada unfavorable histology neuroblastoma, diagnosed between 1 and 21 years of age (inclusive)
• INSS Stages 2A or 2B, N-myc amplified, Shimada unfavorable histology, diagnosed between 1 and 21 years of age (inclusive)
• INSS Stage 4 neuroblastoma, with Shimada unfavorable histology, diagnosed under 365 days of age
• Patients with intermediate or low risk neuroblastoma, who have achieved a second or subsequent partial response or better following chemotherapy treatment of first or subsequent relapse
• Patients must have recovered from the toxic effects of prior chemotherapy prior to treatment on this study, and must have both an absolute lymphocyte count and an absolute neutrophil count greater than 500/mm3.
• Patients with disease status outlined in the first bullet who have been treated with allogeneic tumor vaccine are eligible for treatment with autologous tumor vaccine when that product becomes available
• Patients may not concurrently receive any investigational agents or other tumor vaccines.
• Patients must be HIV-negative.
• Female patients must not be pregnant or lactating.
• Patients must have autologous transduced neuroblastoma cells available that are demonstrably producing \> 150 pg IL-2/10e6 cells/24 hours.
• Patients or legal guardians must sign an informed consent according to institutional guidelines.
• Patients who are sexually active must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom.

Sponsors & Collaborators

• Malcolm Brenner: lead
• Baylor College of Medicine: collaborator
• Center for Cell and Gene Therapy, Baylor College of Medicine: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Heidi V Russell, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Departments of Medicine and Pediatrics/Director Center for Cell and Gene Therapy

Study Record Dates

• First Submitted: October 30, 2002
• First Posted: November 1, 2002
• Study Start: November 1, 1999
• Primary Completion: December 1, 2004
• Study Completion: October 1, 2009
• Last Updated: July 27, 2012

Record last verified: 2012-07

Locations

US (1)