NCT02173093

Brief Summary

Previous research has demonstrated that investigators can coat (arm) T cells with a special molecule called GD2 bispecific antibody that will help T cells recognize neuroblastoma and osteosarcoma cells and kill them. This bispecific antibody recognizes GD2, a protein found on almost all neuroblastoma and osteosarcoma cells. The investigators put the GD2 bispecific antibody on T cells and give large numbers of these T cells back to patients. The investigators think that these T cells may have a better chance of killing GD2 expressing tumor cells when they are armed with GD2 bispecific antibody. This trial studies the side effects and best dose of activated T cells armed with GD2 bispecific antibody and how well they work in treating patients with neuroblastoma, osteosarcoma, and other GD2-positive solid tumors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

5.1 years

First QC Date

June 22, 2014

Last Update Submit

January 25, 2019

Conditions

Disseminated NeuroblastomaRecurrent Neuroblastoma

Keywords

NeuroblastomaSolid tumorImmunotherapy targeting GD2Bispecific antibodiesActivated T cells

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD) of GD2Bi-aATC

    Safety of GD2Bi-aATC infusions is evaluated to determine MTD

    35 days

Secondary Outcomes (2)

  • Anti-tumor activity

    Up to 12 months

  • Immune responses after GD2Bi-aATC infusions

    Up to 12 months

Study Arms (1)

Treatment (IL-2, GM-CSF, GD2Bi-aATC)

EXPERIMENTAL

Patients receive IL-2 SC daily on days -2 to 35, GM-CSF SC twice weekly x 5 weeks, and GD2Bi-aATC IV over 30 minutes twice weekly x 4 weeks for a total of 8 infusions. Laboratory evaluations of immune responses are obtained prior and after immunotherapy.

Biological: IL-2Biological: GD2Bi-aATCBiological: GM-CSFOther: laboratory evaluations of immune responses

Interventions

IL-2BIOLOGICAL

Given SC

Also known as: aldesleukin, Proleukin, recombinant human interleukin-2, recombinant interleukin-2
Treatment (IL-2, GM-CSF, GD2Bi-aATC)
GD2Bi-aATCBIOLOGICAL

Given IV

Also known as: GD2Bi-armed aATC
Treatment (IL-2, GM-CSF, GD2Bi-aATC)
GM-CSFBIOLOGICAL

Given SC

Also known as: sargramostin, Leukine, Prokine
Treatment (IL-2, GM-CSF, GD2Bi-aATC)
laboratory evaluations of immune responsesOTHER

Correlative studies

Also known as: laboratory biomarker analysis
Treatment (IL-2, GM-CSF, GD2Bi-aATC)

Eligibility Criteria

Age13 Months - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The target tumor is limited to neuroblastoma and the diagnosis should be histologically verified.
  • Patients must have refractory or recurrent malignancy; patient's current disease state must be one for which no known curative therapy is available;
  • Patients should not receive any other experimental or phase 1 therapy within 3 weeks prior to study enrollment and monoclonal antibody therapy within 6 weeks
  • To be eligible for phase I study patients should have primary refractory or relapsed disease as evidenced by:
  • Local tumor recurrence measurable on CT or magnetic resonance imaging (MRI) scans with or without metastatic lesions
  • Refractory bone marrow involvement in patients with NB
  • NB with MIBG-positive skeletal lesions
  • The presence of radiographically measurable disease immediately prior to start of Phase I immunotherapy is not an eligibility requirement in the following situations:
  • In patients with NB who have documented bone marrow (BM) involvement;
  • In patients with NB who have MIBG-positive bony lesion(s);
  • An additional eligibility requirement for phase II study includes the presence of radiographically measurable disease with the exception of MIBG-positive NB or NB with bone marrow involvement:
  • Patients must have a Lansky or Karnofsky performance status score of \>= 70
  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
  • Myelosuppressive chemotherapy: must not have received within 3 weeks of starting immunotherapy (IT)
  • Hematopoietic growth factors: at least 7 days since the last dose of growth factor therapy
  • +4 more criteria

You may not qualify if:

  • Patients who are pregnant or breast-feeding are not eligible for this study; negative pregnancy tests must be obtained in girls who are postmenarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy and for 3 months after the last dose of GD2Bi-aATC; breastfeeding women should be excluded
  • Patients who have an uncontrolled infection are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University of Virginia, Department of Pediatrics, Hematology/Oncology

Charlottesville, Virginia, 22908, United States

RECRUITING

Related Publications (1)

  • Park JA, Santich BH, Xu H, Lum LG, Cheung NV. Potent ex vivo armed T cells using recombinant bispecific antibodies for adoptive immunotherapy with reduced cytokine release. J Immunother Cancer. 2021 May;9(5):e002222. doi: 10.1136/jitc-2020-002222.

    PMID: 33986124DERIVED

MeSH Terms

Conditions

Neuroblastoma

Interventions

Interleukin-2aldesleukinGranulocyte-Macrophage Colony-Stimulating Factorsargramostim

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)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological FactorsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth Factors

Study Officials

  • Maxim Yankelevich

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Davis

CONTACT

haw5d@virginia.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2014

First Posted

June 24, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

US(3)