NCT00004229

Brief Summary

Phase I trial to study the effectiveness of endostatin in treating patients who have advanced solid tumors. Endostatin may stop the growth of cancer by stopping blood flow to the tumor.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 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

October 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

April 19, 2004

Completed
Last Updated

February 11, 2013

Status Verified

December 1, 2002

Enrollment Period

3 years

First QC Date

January 28, 2000

Last Update Submit

February 8, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (1)

Arm I

EXPERIMENTAL

Patients undergo a biopsy during prestudy and after the second course of treatment. Patients receive endostatin IV daily for 4 weeks. Patients on dose level 1-6 receive endostatin over 20 minutes. Patients on dose level 7 receive endostatin over 40 minutes, with no treatment on day 2 of the first course only. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of endostatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

Biological: recombinant human endostatin

Interventions

recombinant human endostatinBIOLOGICAL
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven advanced solid tumor for which no standard curative therapy exists * Must be amenable to biopsy At least 1 site of measurable disease outside of irradiated field * No brain metastases by CT or MRI scan PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-1 * WBC greater than 3,000/mm3 * Absolute neutrophil count greater than 1,500/mm3 * Platelet count greater than 100,000/mm3 * Hemoglobin greater than 10 g/dL * Bilirubin less than 1.5 times upper limit of normal (ULN) * ALT and AST less than 2.0 times ULN * PT/PTT less than 1.5 times ULN * Creatinine less than 1.5 mg/dL OR creatinine clearance greater than 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent uncontrolled medical or psychiatric disorder * No history of bleeding diathesis PRIOR CONCURRENT THERAPY: * No concurrent over the counter biologic agents (e.g., shark cartilage) * At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) * No more than 3 prior chemotherapy regimens for metastatic or recurrent disease (ECOG 1) * Prior adjuvant chemotherapy for nonmetastatic disease allowed * Concurrent stable dose of hormone replacement therapy allowed * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy * At least 24 hours since minor surgery (e.g., central venous placement) * At least 4 weeks since major surgery (e.g., laparotomy, thoracotomy, or craniotomy) * At least 30 days since other prior investigational agents * No concurrent herbal remedies * No concurrent usage of products containing heparin * No other concurrent anticancer therapy * Concurrent multivitamins allowed

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

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Interventions

Endostatins

Intervention Hierarchy (Ancestors)

Angiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological Factors

Study Officials

  • Roy S. Herbst, MD, PhD

    M.D. Anderson Cancer Center

    STUDY CHAIR

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

January 28, 2000

First Posted

April 19, 2004

Study Start

October 1, 1999

Primary Completion

October 1, 2002

Last Updated

February 11, 2013

Record last verified: 2002-12

Locations

US(1)