NCT00003023

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody A1G4 with BCG may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody A1G4 plus BCG in treating patients with cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

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

March 1, 1997

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

7.8 years

First QC Date

November 1, 1999

Last Update Submit

January 17, 2013

Conditions

NeuroblastomaSarcoma

Keywords

metastatic osteosarcomarecurrent adult soft tissue sarcomadisseminated neuroblastomastage 4S neuroblastomarecurrent neuroblastomarecurrent osteosarcomametastatic childhood soft tissue sarcomarecurrent childhood soft tissue sarcomastage IV adult soft tissue sarcoma

Interventions

BCG vaccineBIOLOGICAL
monoclonal antibody A1G4 anti-idiotype vaccineBIOLOGICAL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed GD2 positive tumors which include: * High risk neuroblastoma (stage IV, or N-myc amplified, or localized neuroblastoma multiply recurrent) * Recurrent or metastatic osteosarcoma * Recurrent or metastatic GD2 positive sarcomas * If free of disease, patient must be fully recovered from toxic effects or complications of prior treatments (chemotherapy or surgery) * No greater than 6 months since last chemotherapy or surgery before first injection of A1G4 PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Life expectancy: * At least 6 months Hematopoietic: * Absolute neutrophil count greater than 500/mm\^3 * Absolute leukocyte count greater than 500/mm\^3 * Peripheral T-cell phytohemagglutinin activation (PHA) at least 50% of normal Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No significant heart disease (NYHA class III or IV) Other: * No other serious intercurrent illnesses * No active infections requiring antibiotics * No active bleeding * No primary immunodeficiency * Not pregnant or nursing * Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent antibiotics * No prior mouse antibodies and detectable human antimouse antibody (HAMA) titer Chemotherapy: * See Disease Characteristics * At least 6 weeks since nitrosoureas * At least 4 weeks since other systemic chemotherapy Endocrine therapy: * No concurrent nonsteroidal anti-inflammatory agents * No concurrent corticosteroid Radiotherapy: * At least 4 weeks since radiotherapy * No prior radiation therapy to the spleen Surgery: * See Disease Characteristics * No splenectomy

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

NeuroblastomaSarcomaOsteosarcoma

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tuberculosis VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Nai-Kong V. Cheung, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 1, 1997

Primary Completion

January 1, 2005

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

US(1)