Endostatin in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004229
First received: January 28, 2000
Last updated: February 8, 2013
Last verified: December 2002
  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: 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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004229

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

Additional Information:
No publications provided

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
Study First Received: January 28, 2000
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms
Endostatins
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014