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

January 28, 2000
February 8, 2013
October 1999
October 2002   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004229 on ClinicalTrials.gov Archive Site
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Endostatin in Treating Patients With Advanced Solid Tumors
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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Biological: recombinant human endostatin
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.
Intervention: Biological: recombinant human endostatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
October 2002   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004229
NCI-2012-02314, MDA-ID-99201, NCI-T99-0087, CDR0000067471
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Roy S. Herbst, MD, PhD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP