NCT00005061

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 relapsed or refractory solid tumors.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
3 countries

4 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

December 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

April 12, 2004

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

1.5 years

First QC Date

April 6, 2000

Last Update Submit

July 17, 2012

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

bevacizumabBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven relapsed or refractory progressive solid tumor that is not amenable to treatment with standard therapies No brain involvement or leptomeningeal disease PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Postmenopausal Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL No bleeding or clotting abnormalities Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: Normal cardiac function by 12 lead ECG Other: No unstable systemic disease or uncontrolled infection that would preclude study participation No concurrent infection requiring antibiotics Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 70 days after study No psychologic, familial, sociologic, or geographic condition that could preclude compliance HIV negative HTLV-1 negative Hepatitis B surface antigen negative No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix No allergy to protein therapeutics PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior hormonal antitumor therapy No concurrent steroids or hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Concurrent radiotherapy allowed Surgery: Greater than 4 weeks since prior surgery except biopsy or fine needle aspiration of tumor masses Other: At least 4 weeks since other prior investigational drugs or therapies No other concurrent anticancer treatments No other concurrent investigational therapy

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

Sponsors & Collaborators

Study Sites (4)

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3508 GA, Netherlands

Location

University Hospital of Linkoping

Linköping, S-581 85, Sweden

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Gordon Jayson, MD

    The Christie NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2000

First Posted

April 12, 2004

Study Start

December 1, 1999

Primary Completion

June 1, 2001

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

GB(1)NL(2)SE(1)