Endostatin in Treating Patients With Advanced Solid Tumors

February 8, 2013 updated by: National Cancer Institute (NCI)

A Phase I Surrogate Endpoint Trial of Human Recombinant Endostatin in Patients With Advanced Solid Tumors Amenable to Biopsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

I. Determine the optimal biologic dose of endostatin in patients with advanced solid tumors.

II. Determine the safety and tolerability of this regimen in these patients. III. Determine the extent, frequency, and duration of tumor response in these patients on this regimen.

IV. Determine the pharmacokinetic profile and interpatient pharmacologic variability of this regimen in these patients.

V. Determine the recommended phase II dose and schedule of this regimen.

OUTLINE: This is a dose escalation study.

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.

Patients are followed for 1 month.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Roy S. Herbst, MD, PhD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (Actual)

October 1, 2002

Study Registration Dates

First Submitted

January 28, 2000

First Submitted That Met QC Criteria

April 16, 2004

First Posted (Estimate)

April 19, 2004

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

December 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02314
  • MDA-ID-99201
  • NCI-T99-0087
  • CDR0000067471 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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