Status:
COMPLETED
A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor Cells
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Neuroblastoma
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
The investigators intend to test the safety, and immunologic and clinical efficacy of a combination of 2 allogeneic neuroblastoma tumor cell line vaccines, one of which has been genetically modified t...
Detailed Description
TREATMENT PLAN: Standard Chemotherapy for Neuroblastoma: Standard therapy for neuroblastoma is given in 3 phases: induction, consolidation, and maintenance. For enrollment in this vaccine study patien...
Eligibility Criteria
Inclusion
- Age \<21 years at time of diagnosis
- Histological proof of high-risk neuroblastoma at diagnosis
- Anticipating single autologous stem cell rescue following high dose consolidation chemotherapy
- Meet all eligibility criteria for high dose chemotherapy with stem cell rescue per institutional standard
- Signed informed consent
- Patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
- HIV negative
Exclusion
- Patients must not be currently receiving any investigational agents or have received any tumor vaccines within the previous six months
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant
- HIV-positive patients regardless of treatment status
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00703222
Start Date
June 1 2008
End Date
May 1 2025
Last Update
July 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Texas Children's Hospital
Houston, Texas, United States, 77030