Overview

Autologous Stem Cell Rescue With CD133+ Selected Cells in High-Risk Neuroblastoma

Status:
Terminated
Trial end date:
2012-09-05
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to learn how long it takes for certain types of transplanted stem cells to produce new blood cells. The safety of this treatment will also be studied. Finally, researchers want to learn if collecting the cells with the CliniMACS device can decrease the possibility of tumor cells contaminating (appearing in) the stem cells that are reinfused into participants.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Carboplatin
Etoposide
Etoposide phosphate
Melphalan
Criteria
Inclusion Criteria:

1. Newly diagnosed high-risk Neuroblastoma defined as: a. INSS 2A/2B older then 365 days
with MYCN amplified, unfavorable histology, and any ploidy. b. INSS Stage 3, older
than 365 days with MYCN amplification and/or unfavorable histology. c. INSS Stage 4 or
4S, less than 365 days of age, with MYCN amplification d. INSS Stage 4, over 365,
regardless of MYCN amplification or histology.

2. Pre-transplant modalities may include surgery, chemotherapy, or radiation therapy.
Radiation must not include lung fields. Only patients in complete response (CR), or
partial response (PR) at the primary site will be eligible.

3. Any recurrent neuroblastoma with at least a partial response to salvage therapy.

4. Lansky performance score greater than or equal to 50 for patients or Zubrod performance status score of 0-2 for patients > 16 years of age.

5. No symptomatic pulmonary disease. forced expiratory volume in 1 second (FEV1), forced
vital capacity (FVC), and Carbon Monoxide Diffusing Capacity (DLCO) >/= 50% of
expected corrected for hemoglobin. If unable to perform pulmonary function test (most
children < 6 years of age), pulse oximetry >/= 92% on room air.

6. Adequate cardiac function as demonstrated by left ventricular ejection fraction >/=
50% by echocardiogram.

7. Adequate hepatic function as defined as serum glutamic-oxaloacetic transaminase, SGOT
(AST) and serum glutamic-pyruvic transaminase, SGPT (ALT)< 5 times upper limits of
normal.

8. All patients and/or their parents or legal guardians must sign a written informed
consent.

9. Females of childbearing potential defined as not post-menopausal for 12 months or no
previous surgical sterilization must have a negative urine pregnancy test within 30
days of registering. Patients will be informed of the risk of not using adequate
contraception.

Exclusion Criteria:

1. Patient is pregnant or breast-feeding.

2. Active infection not controlled by antibiotics after seven days of therapy.

3. Brain metastases.