NCT00052403

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced solid tumors.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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

February 1, 2002

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

First QC Date

January 24, 2003

Last Update Submit

January 15, 2014

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

monoclonal antibody anti-anb3 integrinDRUG
anti-cytokine therapyPROCEDURE
antiangiogenesis therapyPROCEDURE
antibody therapyPROCEDURE
biological response modifier therapyPROCEDURE
growth factor antagonist therapyPROCEDURE
monoclonal antibody therapyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective treatment exists
  • Measurable or evaluable disease
  • Must have clinical or radiological evidence of disease
  • Disease must be accessible to biopsy and imaging studies
  • No known brain metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • and over
  • Performance status
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Life expectancy
  • At least 3 months
  • Hematopoietic
  • Absolute neutrophil count at least 2,000/mm\^3
  • +31 more criteria

You may not qualify if:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Prior taxanes allowed
  • No concurrent chemotherapy
  • Endocrine therapy
  • No concurrent hormonal therapy except:
  • Concurrent hormonal replacement therapy
  • Concurrent medication for maintaining castrate status in patients with progressive hormone refractory prostate cancer
  • Radiotherapy
  • At least 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of the bone marrow
  • No concurrent radiotherapy
  • Surgery
  • More than 4 weeks since prior surgery
  • Other
  • No other concurrent investigational or commercial agents or therapies for the malignancy
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Immunization, PassiveAdjuvants, ImmunologicAntibodies, Monoclonal

Intervention Hierarchy (Ancestors)

ImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesImmunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Patricia LoRusso, DO

    Harper Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

February 1, 2002

Last Updated

January 16, 2014

Record last verified: 2014-01