NCT00098943

Brief Summary

RATIONALE: Targeted therapy with tumor necrosis factor combined with a fusion protein may stop the growth of solid tumors by stopping blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of NGR-TNF in treating patients with advanced solid tumors.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_1 colorectal-cancer

Geographic Reach
2 countries

2 active sites

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

September 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

3.2 years

First QC Date

December 8, 2004

Last Update Submit

September 20, 2012

Conditions

Colorectal CancerHead and Neck CancerKidney CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificstage IV renal cell cancerrecurrent renal cell cancerstage IV colon cancerrecurrent colon canceranaplastic thyroid cancerinsular thyroid cancerthyroid gland medullary carcinomastage IV follicular thyroid cancerstage IV papillary thyroid cancerrecurrent thyroid cancerrecurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent verrucous carcinoma of the larynxrecurrent verrucous carcinoma of the oral cavitystage IV verrucous carcinoma of the oral cavitystage IV verrucous carcinoma of the larynxrecurrent adenoid cystic carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavityrecurrent basal cell carcinoma of the lipstage IV basal cell carcinoma of the liprecurrent mucoepidermoid carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavityrecurrent lymphoepithelioma of the nasopharynxrecurrent lymphoepithelioma of the oropharynxstage IV lymphoepithelioma of the nasopharynxstage IV lymphoepithelioma of the oropharynxrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent midline lethal granuloma of the paranasal sinus and nasal cavitystage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV midline lethal granuloma of the paranasal sinus and nasal cavitymetastatic parathyroid cancerrecurrent parathyroid cancerrecurrent salivary gland cancerstage IV salivary gland cancer

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting toxicity and maximum tolerated dose as measured by CTC v 3.0

Secondary Outcomes (2)

  • Clinical response as measured by RECIST criteria

  • Mechanism of action as measured by Dynamic Imaging

Interventions

CNGRC peptide-TNF alpha conjugateBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of advanced solid tumor not amenable to any clinical improvement by current standard treatments * Preferably tumors well known to be very angiogenic (e.g., renal, colon, thyroid, and head and neck cancers) * No clinical signs of CNS involvement PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 OR * WHO 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin \< 1.5 times upper limit of normal (ULN) * AST and/or ALT \< 2.5 times ULN (5 times ULN in the presence of liver metastases) Renal * Creatinine \< 1.5 times ULN Cardiovascular * Cardiac function normal * No uncontrolled hypertension * No condition in which hypovolemia and its consequences (e.g., increased stroke volume, elevated blood pressure) or hemodilution could represent a risk to the patient Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No active or uncontrolled systemic infection * No other uncontrolled disease, serious illness, or medical condition that would preclude study participation * No known hypersensitivity/allergic reaction to human albumin preparations or any of the excipients * No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * At least 28 days since prior immunotherapy Chemotherapy * At least 28 days since prior chemotherapy and recovered Endocrine therapy * At least 28 days since prior hormonal therapy Radiotherapy * At least 28 days since prior radiotherapy and recovered * No prior radiotherapy to \> 25% of bone marrow reserve Surgery * More than 2 weeks since prior surgery Other * No other concurrent anticancer therapy * No other concurrent investigational agents

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

Sponsors & Collaborators

Study Sites (2)

University Medical Center Hamburg - Eppendorf

Hamburg, D-20246, Germany

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Related Publications (5)

  • van Laarhoven HW, Fiedler W, Desar IM, van Asten JJ, Marreaud S, Lacombe D, Govaerts AS, Bogaerts J, Lasch P, Timmer-Bonte JN, Lambiase A, Bordignon C, Punt CJ, Heerschap A, van Herpen CM. Phase I clinical and magnetic resonance imaging study of the vascular agent NGR-hTNF in patients with advanced cancers (European Organization for Research and Treatment of Cancer Study 16041). Clin Cancer Res. 2010 Feb 15;16(4):1315-23. doi: 10.1158/1078-0432.CCR-09-1621. Epub 2010 Feb 9.

    PMID: 20145168RESULT

  • Van Laarhoven H, Fiedler W, Desar IM, et al.: Phase I and DCE-MRI evaluation of NGR-TNF, a novel vascular targeting agent, in patients with solid tumors (EORTC 16041). [Abstract] J Clin Oncol 26 (Suppl 15): A-3521, 2008.

    RESULT

  • Heerschap A, Fiedler W, Marreaud S, et al.: A phase I study of NGR-TNF, a novel vascular targeting agent, in patients with refractory solid tumors (EORTC 16041). [Abstract] J Clin Oncol 25 (Suppl 18): A-14074, 2007.

    RESULT

  • van Herpen C, Fiedler W, Marreaud S, et al.: A biological and pharmacologic phase I study of NGR-TNF, a novel vascular targeting agent, in patients with refractory solid tumors (EORTC 16041). [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-B78, 2007.

    RESULT

  • van Herpen C, Fiedler W, Toma S, et al.: Phase I study of NGR-TNF, a novel vascular targeting agent, in patients with refractory solid tumours (EORTC 16041). [Abstract] European Journal of Cancer Supplements 4 (12): A-366, 113, 2006.

    RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsHead and Neck NeoplasmsKidney NeoplasmsCarcinoma, Renal CellColonic NeoplasmsThyroid Carcinoma, AnaplasticCarcinoma, MedullaryAdenocarcinoma, FollicularThyroid Cancer, PapillaryThyroid NeoplasmsSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactoryParathyroid NeoplasmsSalivary Gland Neoplasms

Interventions

tumor necrosis factor-alpha, CNGRC fusion protein, human

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve TissueAdenocarcinoma, PapillaryEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid DiseasesCarcinoma, Squamous CellNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParathyroid DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Study Officials

  • Cornelis J. A. Punt, MD, PhD

    Universitair Medisch Centrum St. Radboud - Nijmegen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2004

First Posted

December 9, 2004

Study Start

September 1, 2004

Primary Completion

November 1, 2007

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

DE(1)NL(1)