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Endostatin in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004229
First Posted: April 19, 2004
Last Update Posted: February 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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.

Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific Biological: recombinant human endostatin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Surrogate Endpoint Trial of Human Recombinant Endostatin in Patients With Advanced Solid Tumors Amenable to Biopsy

Further study details as provided by National Cancer Institute (NCI):

Enrollment: 30
Study Start Date: October 1999
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004229


Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: Roy S. Herbst, MD, PhD M.D. Anderson Cancer Center
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004229     History of Changes
Other Study ID Numbers: NCI-2012-02314
MDA-ID-99201
NCI-T99-0087
CDR0000067471 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: January 28, 2000
First Posted: April 19, 2004
Last Update Posted: February 11, 2013
Last Verified: December 2002

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Endostatins
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors


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