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| Sponsors and Collaborators: |
St. Jude Children's Research Hospital National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002713 |
Purpose
RATIONALE: Inserting the gene for interleukin-2 into a person's neuroblastoma cells may make the body build an immune response and kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of using interleukin-2 gene-modified neuroblastoma cells in treating children who have relapsed or refractory neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Drug: aldesleukin Procedure: gene-modified tumor cell vaccine therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | PHASE I STUDY OF CYTOKINE GENE MODIFIED AUTOLOGOUS NEUROBLASTOMA CELLS FOR TREATMENT OF RELAPSED/REFRACTORY NEUROBLASTOMA USING AN ADENOVIRAL VECTOR |
| Study Start Date: | September 1995 |
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.
Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Tennessee | |
| Saint Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| Study Chair: | Laura C. Bowman, MD | AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus |
More Information
| Study ID Numbers: | CDR0000064539, SJCRH-CANA, NCI-H95-0797 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002713 |
| Health Authority: | United States: Federal Government |
|
recurrent neuroblastoma |
|
Neuroectodermal Tumors Aldesleukin Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Neuroectodermal Tumors, Primitive, Peripheral Recurrence Neuroblastoma Neoplasms, Glandular and Epithelial |
|
Anti-Infective Agents Neoplasms Anti-HIV Agents Neoplasms by Histologic Type Anti-Retroviral Agents Antineoplastic Agents |
Therapeutic Uses Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Antiviral Agents Pharmacologic Actions |
