Using Gene Modified Neuroblastoma Cells for the Treatment of Relapsed/Refractory Neuroblastoma
NCT ID: NCT00062855
Last Updated: 2012-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
1997-11-30
2006-03-31
Brief Summary
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The purpose of this study is to learn the side effects and safe 'dosage' of these special cells.
Detailed Description
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The modified cancer cells will be injected under the patient's skin. There will be four shots. The second and subsequent shots will have ten times as many cells producing lymphotactin as the first. We do not know the best amount of special cells to use, so different patients will get different numbers of cells.
Before the second shot, and then again about 2 weeks later, we will remove some of the modified cells from the patient's body and study them. We will do this by removing a section of skin (referred to as a skin biopsy) at the place where the cells were injected. This test will help us to see whether or not the modified cells are killing cancer cells.
To study how the immunity is working in the patient's system, we will take blood samples prior to each injection, two to four days after each injection, and may repeat this 5-7 days after each injection if your doctor thinks that is necessary.
After patients have received the first set of 4 injections a complete evaluation is performed to see how this research treatment is working. If these evaluations look okay and if more injections are available, patients will have the option to receive a second set of 4 injections. If patients receive the second set of 4 injections, they will again have blood samples taken after each injection.
After injections stop, all patients will have blood samples collected once a month for a year, and then once a year for fifteen years.
To see if this research treatment is working, we will do CAT scans, MRIs, or bone scans (these are different types of x-rays). We will also take a bone marrow biopsy (bone marrow will be removed by use of a needle so that it can be looked at under the microscope). These tests will be done prior to treatment and again eight weeks later. In addition, if patients receive the second set of four injections, these tests will be repeated at six months.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gene Modified Neuroblastoma Cells
Gene modified neuroblastoma cells given as 4 subcutaneous injections over 5 weeks
Skin Biopsy
Gene Modified Neuroblastoma Cells
The first two injections will be given at week 1 and week 2 (i.e., separated by one week). Patients will then have a two-week rest and the remaining two injections will be given (again separated by one week) at week 4 and week 5.
A complete evaluation for evidence of toxicity and response will be performed at week 8 (after a 3 week rest).
At the 8 week (month 2) evaluation, in the absence of progressive disease requiring therapy without excessive toxicity and if more transduced cells are available, the patient will have the option to receive four additional SC injections each separated by 1 month at the higher of the two dosage levels they originally received.
Interventions
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Skin Biopsy
Gene Modified Neuroblastoma Cells
The first two injections will be given at week 1 and week 2 (i.e., separated by one week). Patients will then have a two-week rest and the remaining two injections will be given (again separated by one week) at week 4 and week 5.
A complete evaluation for evidence of toxicity and response will be performed at week 8 (after a 3 week rest).
At the 8 week (month 2) evaluation, in the absence of progressive disease requiring therapy without excessive toxicity and if more transduced cells are available, the patient will have the option to receive four additional SC injections each separated by 1 month at the higher of the two dosage levels they originally received.
Eligibility Criteria
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Inclusion Criteria
* Patients must have a life expectancy of at least 8 weeks.
* Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study, and have an absolute lymphocyte and neutrophil count of \>500/mm3 each.
* Patients must not be currently receiving any investigational agents or have not received any tumor vaccines within the previous six weeks.
* Patients must not be HIV-positive.
* Patients must have bilirubin \<1.5 mg%.
* Patients must have creatinine \<1.5 mg/dl.
* Patients must have ECOG performance status of 0-2.
* Patients must have autologous transduced neuroblastoma cells available that are demonstrably producing \>150 pg IL-2/106 cells/24 hr and are secreting Lptn.
* Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
* Sexually active patients 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.
21 Years
ALL
No
Sponsors
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Center for Cell and Gene Therapy, Baylor College of Medicine
OTHER
Baylor College of Medicine
OTHER
Responsible Party
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Malcolm Brenner
Professor, Director Center for Cell and Gene Therapy
Principal Investigators
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Malcolm Brenner, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Texas Children's Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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Cyche
Identifier Type: -
Identifier Source: secondary_id
H6442
Identifier Type: -
Identifier Source: org_study_id
NCT00002713
Identifier Type: -
Identifier Source: nct_alias