Trials Sponsors Conditions Drugs Pricing

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHlead

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

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

Enrollment

30 participants (actual enrollment reported by the registry).

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 1999

Date type not reported

This date has not been verified as actual or estimated.

Endostatin in Treating Patients With Advanced Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

First Posted

Conditions

Keywords

Study Arms (1)

Arm I

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

First Posted

Conditions

Keywords

Study Arms (1)

Arm I

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations