NCT00609141

Brief Summary

This phase I clinical trial is studying the side effects and best dose of IMC-A12 in treating young patients with relapsed or refractory Ewing sarcoma/peripheral primitive neuroectodermal tumor or other solid tumors. Monoclonal antibodies, such as IMC-A12, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

June 19, 2014

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

February 2, 2008

Last Update Submit

June 18, 2014

Conditions

Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorUnspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (3)

  • Adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0

    Toxicity tables will be constructed to summarize the observed incidence by severity and type of toxicity.

    Weekly during each course

  • MTD or recommended phase II dose

    MTD will be the maximum dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT). DLT is defined as any hematological and non-hematological toxicities that is possible, probably, or definitely attributed to IMC-A12.

    During course 1

  • Pharmacokinetics of IMC-A12

    At baseline, days 1, 8, 15, 22, and 28 of course 1, and days 15 and 28 of course 2

Secondary Outcomes (1)

  • Response rate (complete or partial response) in patients with Ewing sarcoma/peripheral PNET

    Up to 30 days after completion of treatment

Study Arms (1)

Treatment (monoclonal antibody therapy)

EXPERIMENTAL

Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 4 weeks for up to 2 years in the absence of unacceptable toxicity or disease progression.

Biological: cixutumumabOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

cixutumumabBIOLOGICAL

Given IV

Also known as: anti-IGF-1R recombinant monoclonal antibody IMC-A12, IMC-A12
Treatment (monoclonal antibody therapy)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (monoclonal antibody therapy)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (monoclonal antibody therapy)

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed solid tumor
  • Relapsed or refractory disease
  • No central nervous system (CNS) tumor or lymphoma
  • Histological confirmation may have been made at original diagnosis or at relapse
  • Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
  • Measurable or evaluable disease
  • Patients with Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET) must have tissue blocks or slides available
  • Study chair must be notified if tissue blocks or slides are not available
  • Karnofsky performance status (PS) ≥ 50% (patients \> 10 years of age) and Lansky (PS) ≥ 50% (patients ≤ 10 years of age)
  • Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
  • to \< 2 years (males and females 0.6 mg/dL)
  • to \< 6 years (males and females 0.8 mg/dL)
  • to \< 10 years (males and females 1.0 mg/dL)
  • to \< 13 years (males and females 1.2 mg/dL)
  • +34 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

COG Phase I Consortium

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Neuroectodermal Tumors, Primitive, Peripheral

Interventions

cixutumumab

Condition Hierarchy (Ancestors)

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

Study Officials

  • Suman Malempati

    COG Phase I Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2008

First Posted

February 6, 2008

Study Start

January 1, 2008

Primary Completion

September 1, 2009

Last Updated

June 19, 2014

Record last verified: 2014-06

Locations

US(1)