PHASE I STUDY OF CYTOKINE GENE MODIFIED AUTOLOGOUS NEUROBLASTOMA CELLS FOR TREATMENT OF RELAPSED/REFRACTORY NEUROBLASTOMA USING AN ADENOVIRAL VECTOR
N/A
20 Years
Both
Neuroblastoma
Trial Information
PHASE I STUDY OF CYTOKINE GENE MODIFIED AUTOLOGOUS NEUROBLASTOMA CELLS FOR TREATMENT OF RELAPSED/REFRACTORY NEUROBLASTOMA USING AN ADENOVIRAL VECTOR
OBJECTIVES: I. Assess in patients with neuroblastoma the safety of up to four subcutaneous
injections of autologous neuroblastoma cells that have been modified by insertion of the
interleukin-2 (IL-2) gene introduced by an adenoviral vector. II. Determine whether major
histocompatibility complex restricted or unrestricted antitumor immune responses are induced
by treatment with IL-2 gene modified autologous neuroblasts. III. Determine the dose of IL-2
gene modified autologous neuroblasts needed to achieve antitumor responses in these
patients. IV. Obtain preliminary data on the antitumor effects of this regimen in these
patients. V. Determine the maximum tolerated dose of this regimen in these patients.
OUTLINE: This is a dose escalation study. Autologous neuroblastoma cells are modified by
insertion of the interleukin-2 (IL-2) gene introduced by an adenoviral vector. Patients
receive IL-2 gene modified autologous neuroblastoma cells subcutaneously on days 1 and 8
followed by 3-4 weeks of rest. Patients with complete or partial response or stable disease
may receive one additional course consisting of 2 additional injections separated by 1 week
at the dose level previously administered on day 8 of course 1. Patients with progressive
disease are taken off study. Cohorts of 3-6 patients receive escalating doses of IL-2 gene
modified autologous neuroblastoma cells until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose limiting toxicity. Patients are followed every other week for 6 weeks,
monthly for 1 year, and then annually for 10 years.
PROJECTED ACCRUAL: A total of 15-24 patients will be accrued for this study over 2.5-4
years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven neuroblastoma at completion of planned
primary therapy Autologous transduced neuroblastoma cells available Demonstrated
production of at least 150 picograms of interleukin-2 per 10 to the 6th cells per day
PATIENT CHARACTERISTICS: Age: Under 21 at diagnosis Performance status: ECOG 0-2 Life
expectancy: At least 2 months Hematopoietic: Absolute neutrophil count greater than
500/mm3* Platelet count greater than 50,000/mm3* *Unless marrow replaced by tumor Hepatic:
Bilirubin less than 1.5 mg/dL AST no greater than 2 times normal PT normal Albumin greater
than 3 g/Dl Renal: Creatinine less than 2 times normal for age OR Creatinine clearance
greater than 80 mL/min per 1.73 square meters Urinalysis normal Metabolic: Electrolytes
(including calcium, phosphate) normal Glucose normal Weight greater than 10th percentile
for age Other: No active infection No concurrent antibiotics other than prophylactic
trimethoprim sulfamethoxazole No requirement for other concurrent drugs except analgesics
HIV negative Not pregnant or nursing Fertile patients must use effective contraception or
practice abstinence for 6 months after study
PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from toxic effects of
prior chemotherapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Laura C. Bowman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Authority:
United States: Federal Government
Study ID:
CDR0000064539
NCT ID:
NCT00002713
Start Date:
September 1995
Completion Date:
Related Keywords:
- Neuroblastoma
- recurrent neuroblastoma
- Neuroblastoma
Name | Location |
|---|---|
| Saint Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
