Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Bizelesin in Treating Patients With Advanced Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Bizelesin in Treating Patients With Advanced Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bizelesin in Treating Patients With Advanced Cancer Clinical research trials and Bizelesin in Treating Patients With Advanced Cancer healthcare trials happen in many 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 generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Bizelesin in Treating Patients With Advanced Cancer. Bizelesin in Treating Patients With Advanced Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Bizelesin in Treating Patients With Advanced Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Bizelesin in Treating Patients With Advanced Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

Home > "B" Clinical Trials Conditions > Bizelesin in Treating Patients With Advanced Cancer

Bizelesin in Treating Patients With Advanced Cancer



Bizelesin in Treating Patients With Advanced Cancer

For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Texas
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of bizelesin in treating patients who have advanced cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of bizelesin in patients with advanced cancer. II. Determine the qualitative and quantitative toxic effects of this therapy in these patients. III. Determine the pharmacokinetics of this therapy in these patients. IV. Determine the recommended dose of this drug for phase II trials. V. Determine the antitumor effects of this therapy in these patients. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive bizelesin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bizelesin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. 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 confirmed malignant solid tumor for which there are no therapeutic options that are potentially curative or have been demonstrated to increase survival - No primary or metastatic CNS malignancy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to more than 10% of bone marrow; No prior electron-beam radiotherapy; At least 4 weeks since other prior radiotherapy - Surgery: Prior surgery allowed - Other: Recovered from prior therapy --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: At least 12 weeks - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL - Hepatic: Bilirubin normal; SGOT no greater than 2.5 times upper limit of normal - Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min - Cardiovascular: No atrial or ventricular arrhythmia requiring medication; No ischemic event within the past 6 months - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active infection; No other active malignancy except curatively treated carcinoma in situ of the cervix or basal cell skin cancer; No other serious concurrent medical illness; No history of seizure disorder requiring active therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
EricRowinsky,  Study Chair,  University of Texas

Brooke Army Medical Center
Fort Sam Houston,  Texas,  78234
United States
 

Cancer Therapy & Research Center
San Antonio,  Texas,  78229
United States
 


Additional Information:
Study ID Numbers:  CDR0000065606;  UTHSC-IDD-93-45,NCI-T93-0166,SACI-IDD-93-45
Study Start Date: August 1997
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003021

Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. BMS-184476 in Treating Patients With Advanced Solid Tumors

2. VNP20009 in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Prior Therapy

3. Valdecoxib in Treating Chronic Pain in Cancer Patients

4. ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy

5. Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Related Studies:

Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials

Bizelesin in Treating Patients With Advanced Cancer
Modify your Search

  Other unspecified adult solid tumor, protocol specific Clinical Trials
  Other Texas Clinical Trials
  Other San Antonio Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103