NCT00006480

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2000

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2000

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

December 31, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

First QC Date

November 6, 2000

Last Update Submit

September 17, 2010

Conditions

Neuroblastoma

Keywords

disseminated neuroblastomarecurrent neuroblastoma

Interventions

aldesleukinBIOLOGICAL
therapeutic autologous lymphocytesBIOLOGICAL
chemotherapyDRUG
ganciclovirDRUG

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
DISEASE CHARACTERISTICS: Histologically and/or radiographically proven disseminated neuroblastoma 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

aldesleukinDrug TherapyGanciclovir

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

TherapeuticsAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Julie R. Park, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2000

First Posted

December 31, 2003

Study Start

May 1, 2000

Study Completion

March 1, 2005

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

US(2)