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A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor Cells After High-Dose Chemotherapy And Autologous Stem Cell Rescue In Patients With High Risk Neuroblastoma


Phase 1/Phase 2
N/A
N/A
Open (Enrolling)
Both
Neuroblastoma

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Trial Information

A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor Cells After High-Dose Chemotherapy And Autologous Stem Cell Rescue In Patients With High Risk Neuroblastoma


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 patients and their physicians must anticipate therapy that will include
consolidation with high dose chemotherapy with stem cell rescue. They will be eligible for
enrollment in the phase I or phase II trial of vaccination with gene modified and
unmodified, allogeneic neuroblastoma cell lines. Patients will receive Induction,
Consolidation, and Maintenance therapy per their institutional standards. A general
description of the therapy follows:

- Induction: Induction consists of multiple cycles of induction chemotherapy with harvest
of autologous stem cells immediately following a particular cycle of chemotherapy per
institutional standards. Local control of the tumor with radiation therapy and/or
surgery occurs following a few cycles of induction chemotherapy or immediately prior to
consolidation therapy.

- Consolidation: Consolidation must consist of high dose chemotherapy with autologous
stem cell rescue (HDT/SCR).

- Maintenance: Starting day +90 after HDT/SCR, patients will be treated with Isotretinoin
(Cis-Retinoic Acid, CRA).

VACCINE DOSING: Vaccine components SJNB-JF-IL2 and SJNB-JF-Lptn will each be dosed at 1x10e7
cells/m2. This will be given in conjunction with an escalating dose of SKNLP vaccine in the
phase I portion of this study. In the phase II portion of this study, the same dose of
SJNB-JF-IL2 and SJNB-JF-Lptn will be given in conjunction with the highest dose of SKNLP
determined in the phase I portion. Vaccination will be administered on an inpatient or
outpatient basis. Patient will be notified of which dose of vaccine cells they will receive
if enrolled in the study.

Phase I Dose Escalation Component: While the investigators do not suspect that addition of a
second irradiated, unmodified neuroblastoma tumor cell line to the previously tested SJNB-JF
gene modified cell line will affect the safety profile of the vaccine, as the SKNLP has not
been tested previously in vaccine studies, the investigators will perform an abbreviated
dose escalation study of the combined vaccine to assess safety. The investigators know that
the vaccine given to patients whose neuroblastoma returned was safe. The vaccine that was
given to those patients was treated with the viruses to make cytokines. The investigators
have never used the 2nd cell group in patients. Because of this, the investigators plan to
treat 3 to 6 patients at a lower dose of cells to see if adding the second cell line is safe
to give.

- Dose Level 1 (3-6 patients) 1x10e6 cells/m2/vaccination dose of SKNLP Unmodified
Neuroblastoma Cell Line Vaccine Component

- Dose Level 2 (3-6 patients) 1x10e7 cells/m2/vaccination dose of SKNLP Unmodified
Neuroblastoma Cell Line Vaccine Component

- SJNB-JF-IL2 and SJNB-JF-Lptn cells are each dosed at 1x10e7 cells/m2/vaccination

Duration of Therapy: In the absence of treatment delays due to adverse events, treatment may
continue with immunizations per the treatment plan up to 12 vaccinations or until one of the
following criteria applies: - Disease progression - Intercurrent illness that prevents
further administration of treatment - Unacceptable adverse events(s) including but not
limited to grade 3-4 non-hematologic toxicity according to CTCAE v3.0. Grade 3 rigors/chills
will be tolerated for 48-72 hours if attributed to vaccination. - Patient decides to
withdraw from the study - General or specific changes in the patient's condition render the
patient unacceptable for further treatment in the judgement of the investigator.


Inclusion Criteria:



Age <21 years at time of diagnosis

Histological proof of high-risk neuroblastoma at diagnosis (see Appendices A and B in Full
Protocol attached in Section S.)

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 Criteria:

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the safety of repeated immunization with gene-modified, IL-2/lymphotactin secreting SJNB-JF-IL2 and SJNB-JF-Lptn cells co-administered with the unmodified SKNLP neuroblastoma cell line.

Outcome Time Frame:

1 year

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:

22053-CHESAT

NCT ID:

NCT00703222

Start Date:

June 2008

Completion Date:

July 2028

Related Keywords:

  • Neuroblastoma
  • high-risk neuroblastoma
  • single autologous stem cell rescue
  • Neuroblastoma

Name

Location

Texas Children's HospitalHouston, Texas