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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004229 |
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 |
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Unspecified Adult Solid Tumor, Protocol Specific |
Biological: recombinant human endostatin |
Phase I |
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 |
Study Start Date: | October 1999 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Roy S. Herbst, MD, PhD | M.D. Anderson Cancer Center |
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 |
unspecified adult solid tumor, protocol specific |
Endostatins Angiogenesis Inhibitors |
Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs Endostatins |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |