NCT00562380

Brief Summary

RATIONALE: Monoclonal antibodies, such as AMG-479, 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. PURPOSE: This phase I trial is studying the side effects and best dose of AMG-479 in treating patients with advanced solid tumors or non-Hodgkin lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for phase_1 lymphoma

Timeline
Completed

Started Oct 2005

Typical duration for phase_1 lymphoma

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

October 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 18, 2013

Status Verified

April 1, 2010

Enrollment Period

4.5 years

First QC Date

November 21, 2007

Last Update Submit

July 17, 2013

Conditions

LymphomaProstate CancerSarcomaSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

cutaneous B-cell non-Hodgkin lymphomaangioimmunoblastic T-cell lymphomastage IV cutaneous T-cell non-Hodgkin lymphomaadult nasal type extranodal NK/T-cell lymphomaanaplastic large cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult grade III lymphomatoid granulomatosisrecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomasmall intestine lymphomasplenic marginal zone lymphomaunspecified adult solid tumor, protocol specificrecurrent Ewing sarcoma/peripheral primitive neuroectodermal tumoradult desmoplastic small round cell tumorrecurrent adult soft tissue sarcomarecurrent prostate cancer

Outcome Measures

Primary Outcomes (2)

  • Safety

  • Pharmacokinetic profile

Secondary Outcomes (7)

  • Level of insulin-like growth factor receptor-1 (IGF-1R) on peripheral blood cells

  • Tumor response measured by modified RECIST

  • Tumor glucose metabolism as measured by fludeoxyglucose F 18-PET/CT scan

  • Anti-AMG-479 antibody formation

  • The incidence of dose-limiting toxicities and the severity of adverse events

  • +2 more secondary outcomes

Interventions

ganitumabBIOLOGICAL
laboratory biomarker analysisOTHER
pharmacological studyOTHER
biopsyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed advanced solid tumors or non-Hodgkin lymphoma that is refractory to standard treatment or for which no curative therapy is available
  • Tumor tissue that is accessible for biopsy by using minimally invasive procedures and must consent to undergo biopsies of the tumor (part 2)
  • Exception for patients with Ewing family tumors or desmoplastic small round cell tumors whose anatomic location would pose an increase in the risk of injury due to biopsy (i.e., bleeding or pneumothorax)
  • Willing to provide existing and/or future paraffin-embedded tumor samples

You may not qualify if:

  • Primary CNS tumors or hematological malignancies, other than non-Hodgkin lymphoma
  • Primary hepatic tumors or at increased risk for hepatic tumors, including any of the following:
  • Hepatitis of any etiology
  • Alcohol abuse or dependency
  • Hepatic adenoma
  • Follicular nodular hyperplasia
  • Autoimmune conditions associated with biliary tract cancer
  • Alpha 1 antitrypsin deficiency
  • Hemochromatosis
  • History of vinyl chloride or thorotrast/thorium dioxide exposure
  • History of histiocytic (Kupffer cell) neoplasia
  • Presence of untreated or symptomatic CNS metastases or symptoms of brain metastases
  • Presence of ascites or pleural effusion requiring medical intervention
  • PATIENT CHARACTERISTICS:
  • ECOG performance status ≤ 2
  • +46 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

LymphomaProstatic NeoplasmsSarcomaImmunoblastic LymphadenopathyLymphoma, T-Cell, CutaneousLymphoma, Extranodal NK-T-CellLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-CellNeuroectodermal Tumors, Primitive, PeripheralDesmoplastic Small Round Cell Tumor

Interventions

ganitumabBiopsy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplasms, Connective and Soft TissueLymphadenopathyLymphoma, T-CellLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Mace L. Rothenberg, MD, FACP

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 22, 2007

Study Start

October 1, 2005

Primary Completion

April 1, 2010

Study Completion

June 1, 2010

Last Updated

July 18, 2013

Record last verified: 2010-04

Locations

US(1)