|
Endostatin in Treating Patients With Advanced Solid Tumors Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Endostatin in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Endostatin in Treating Patients With Advanced Solid Tumors Clinical research trials and Endostatin in Treating Patients With Advanced Solid Tumors medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Endostatin in Treating Patients With Advanced Solid Tumors. Endostatin in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Endostatin in Treating Patients With Advanced Solid Tumors clinical trial. Participants frequently get the best healthcare available for their Endostatin in Treating Patients With Advanced Solid Tumors condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Endostatin in Treating Patients With Advanced Solid Tumors  Endostatin in Treating Patients With Advanced Solid Tumors
Endostatin in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RoyHerbst, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000067471; MDA-ID-99201,NCI-T99-0087
Study Start Date: October 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004229
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
2. Paclitaxel and BMS-214662 in Treating Patients With Advanced Solid Tumors
3. Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
4. Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer
5. KRN5500 in Treating Patients With Metastatic Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Endostatin in Treating Patients With Advanced Solid Tumors
|
|
|
|
|
|
|
|
