Overview
Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma
Status:
Completed
Completed
Trial end date:
2005-03-01
2005-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Inserting genetic material made in the laboratory into a person's blood cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy and gene therapy in treating children who have recurrent or refractory neuroblastoma.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Fred Hutchinson Cancer Research CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Aldesleukin
Ganciclovir
Ganciclovir triphosphate
Criteria
DISEASE CHARACTERISTICS: Histologically and/or radiographically proven disseminatedneuroblastoma Recurrent or refractory to first-line therapy as defined by less than
complete response to standard induction chemotherapy combined with surgical resection
Histologic verification of neuroblastoma required at original diagnosis No radiographically
detectable CNS involvement No clinically evident progressive encephalopathy
PATIENT CHARACTERISTICS: Age: 1 to 17 (children only) Performance status: Not specified
Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified
Renal: No dialysis dependency Cardiovascular: No uncontrolled cardiac arrhythmia No
hypertension requiring pressor support Pulmonary: No requirement for supplemental oxygen
unless expected to resolve within 2 weeks Neurologic: See Disease Characteristics No
refractory seizure disorder Other: No detectable human antimouse antibody reactivity if
received prior murine antibody preparations No history of ganciclovir allergy or
intolerance HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception during and for at least 2 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent antibody therapy during or
after study No other concurrent immunotherapy (e.g., interferons, vaccines, or other
cellular products) Chemotherapy: At least 3 weeks since prior standard or experimental
chemotherapy and recovered Endocrine therapy: No concurrent systemic corticosteroids unless
specifically for amelioration of toxicity induced by transferred T-cell therapy
Radiotherapy: Not specified Surgery: Not specified Other: At least 3 weeks since prior
immunosuppressive therapies and recovered No concurrent pentoxifylline No other concurrent
investigational agents No concurrent ganciclovir, any ganciclovir derivatives, or acyclovir
for non-life-threatening herpes virus infections