A Phase I/II Study Using Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma (ATOMIC)
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Neuroblastoma
Trial Information
A Phase I/II Study Using Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma (ATOMIC)
WHAT IS THE OVERALL TREATMENT PLAN AND HOW MANY VACCINATIONS WILL THE PATIENT RECEIVE? There
will be several injections of the vaccine scheduled. The first injection will be given 3
days after starting oral cytoxan. The 2nd to 4th injections will be given approximately
every 14 days after the previous vaccine. During this time, the patient will be taking oral
cytoxan once a day except on the day of and 4 days following the vaccine. Two to 3 weeks
after the 4th vaccine, the patient will have a complete evaluation of their disease. If the
scans and lab tests show that the patient has not had any serious side-effects, they will be
eligible to receive 4 additional vaccinations given at 3 week intervals. The disease will be
re-evaluated again after vaccine numbers 6 and 8. If the patient is able to complete the
entire study, they will have received a total of 8 vaccinations and the last dose of oral
cytoxan will be 1 month after the 8th vaccination. Total time duration for participating in
this study is 15 years (treatment portion within year 1 and follow up during years 2-15).
Neuroblastoma vaccinations are given like many other vaccines. They will be given
subcutaneously. The injections will be 1/10th of a teaspoon.
MEDICAL TESTS BEFORE STARTING TREATMENT:
Before starting low dose chemotherapy plus oral cytoxan, patients will receive a series of
standard medical tests:
- Physical exam
- Blood tests to measure blood cells, blood salts, kidney and liver function
- Measurements of their disease (CT or MRI of the primary tumor site and any locations of
tumor spread; MIBG or Bone scan; Chest X-ray if they did not have a CT of the chest;
and bone marrow studies if the patient has known bone marrow disease)
- Baseline testing of immune function
- Pregnancy testing will be performed on females of child bearing age
MEDICAL TESTS DURING AND AFTER TREATMENT:
Prior to each vaccine dose, the patient will receive:
- Physical exam
- Blood tests to measure blood cells, blood salts, kidney and liver function
- Measurements of the disease (CT or MRI of the primary tumor site and any locations of
tumor spread; MIBG or Bone scan; Chest X-ray if they did not have a CT of the chest;
and bone marrow studies if they have known bone marrow disease) after the 4th, 6th and
8th vaccine.
- Testing of immune function
- Pregnancy testing will be performed again on females of child bearing age prior to the
5th vaccine
To learn more about the way the vaccine is stimulating the immune cells, we will collect
blood prior to each vaccination and at scheduled time points until 3 months after the last
vaccine treatment. The total amount of blood to be collected on any day is no more than 2
ounces, but will depend upon the weight. This volume is considered safe in teens and adults,
but may be decreased if the patient is anemic. On days when the patient receives the
vaccine, blood will be taken before the cells are given.
Inclusion Criteria
INCLUSION CRITERIA:
- Histologically proven high risk neuroblastoma in first or subsequent relapse or with
primary refractory disease or inability to complete standard therapy
- Age less than 21 at time of initial diagnosis
- Life expectancy 12 weeks or greater
- Karnofsky or Lansky score of 50 or greater
- Platelet count of 50,000/ul or greater
- ANC greater than 750/ul
- Alk Phos level less than 2.5 x upper limit of normal
- Bilirubin less than 2x normal
- AST less than 3x normal
- Hgb 8.0 or greater
- Creatinine 2 x ULN or less OR GFR greater than 40 ml/min/1.73 m2
- Patient has recovered from last chemotherapy or investigational therapy prior to
study enrollment
- Women of child-bearing potential must not be pregnant and take/use effective birth
control while participating in the study.
EXCLUSION CRITERIA:
- Due to the unknown effects of this therapy on a fetus, pregnant women will be
excluded from this research
- Women who are breast-feeding
- Known HIV positive subjects since treatment may be immunosuppressive
- Severe intercurrent infection or uncontrolled condition 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
- Previous use of oral cytoxan for more than 2 consecutive months within the last 6
months
- Patients currently receiving any investigational agents or have received any tumor
vaccines within the previous six months
- Patients, who in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Outcome Description:
Phase I Primary Objective: Evaluate the safety of fixed dose oral cytoxan administered metronomically to coincide with repeated immunizations of gene-modified, IL-2/lymphotactin secreting SJNB-JF-IL2 and SJNB-JF-LTN cells co-administered with unmodified SKNLP neuroblastoma cell lines in patients with a history of relapsed/refractory high-risk neuroblastoma.
Outcome Time Frame:
week 30
Safety Issue:
Yes
Principal Investigator
Chrystal U. Louis, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Baylor College of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
H-26652-ATOMIC
NCT ID:
NCT01192555
Start Date:
September 2010
Completion Date:
September 2030
Related Keywords:
- Neuroblastoma
- Neuroblastoma
- Chemotherapy
- Pediatrics
- Cytoxan
- immunotherapy
- vaccine
- Neuroblastoma
Name | Location |
|---|---|
| Texas Children's Hospital | Houston, Texas |
