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Endostatin in Treating Patients With Advanced Solid Tumors
This study has been completed.
First Received: January 28, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004229
  Purpose

RATIONALE: Endostatin may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of endostatin in treating patients who have advanced solid tumors.


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

MedlinePlus related topics: Cancer
Drug Information available for: Endostatin
U.S. FDA Resources
Study Type: Interventional
Study Design: 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):

Study Start Date: October 1999
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.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

  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 Life expectancy: Not specified Hematopoietic: 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 Hepatic: 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 Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: 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: Biologic therapy: No concurrent over the counter biologic agents (e.g., shark cartilage) Chemotherapy: 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 Endocrine therapy: Concurrent stable dose of hormone replacement therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery: 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) Other: 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
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
M.D. Anderson Cancer Center
Investigators
Study Chair: Roy S. Herbst, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067471, MDA-ID-99201, NCI-T99-0087
Study First Received: January 28, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004229     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Endostatins
Angiogenesis Inhibitors

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

ClinicalTrials.gov processed this record on May 07, 2009