Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia Clinical research trials and Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia. Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia clinical trial. Test subjects typically obtain the finest healthcare available for their Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.

Home > "A" Clinical Trials Conditions > Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia

Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia



Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia

For Condition: relapsing chronic myelogenous leukemia,recurrent adult acute lymphoblastic leukemia,blastic phase chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia
Status: No longer recruiting
Sponsor(s): H. Lee Moffitt Cancer Center and Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.
Details: OBJECTIVES: - Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide. - Determine the duration of hematologic response and overall survival of these patients when treated with this regimen. - Determine the pattern of clinical adverse experience in these patients when treated with this regimen. - Determine the pharmacokinetic profile of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course. Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 24-49 patients will be accrued for this study within 2.5 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of one of the following: - Acute lymphoblastic leukemia - Philadelphia chromosome (Bcr-abl) positive - Refractory to initial therapy OR recurrent following 1 induction therapy regimen with or without consolidation therapy and/or bone marrow transplantation - Blastic phase chronic myelogenous leukemia - Philadelphia chromosome (Bcr-abl) positive - Previously untreated OR recurrent or refractory following 1 induction therapy regimen with or without consolidation therapy including imatinib mesylate - Must not be eligible for bone marrow transplant PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 8 weeks Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2.0 times upper limit of normal (ULN) - AST/ALT no greater than 2 times ULN Renal: - Creatinine no greater than 2.0 times ULN - Creatinine clearance greater than 70 mL/min Cardiovascular: - No uncontrolled angina - No New York Heart Association class III or IV heart disease - No second degree heart block without pacemaker Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study - HIV negative - No uncontrolled infection or other serious concurrent illness - No peripheral neuropathy - No potassium less than 3.0 or greater than 5.5 mEq/L that can not be corrected OR - No magnesium less than 1.2 or greater than 2.5 mEq/L that can not be corrected - Electrolyte imbalances must be corrected prior to study entry PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics - At least 28 days since prior chemotherapy - At least 24 hours since prior hydroxyurea - No prior arsenic trioxide - No other concurrent cytotoxic chemotherapy except intrathecal chemotherapy for CNS leukemia Endocrine therapy: - Not specified Radiotherapy: - At least 28 days since prior radiotherapy - No concurrent radiotherapy including for palliation Surgery: - Not specified Other: - At least 14 days since prior imatinib mesylate - No other concurrent investigational agents - No concurrent amphotericin B
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ThomasLoughran,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute

H. Lee Moffitt Cancer Center and Research Institute
Tampa,  Florida,  33612-9497
United States
 


Additional Information:
Study ID Numbers:  CDR0000068097;  MCC-12395,NCI-1230
Study Start Date: 
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006092

Other Philadelphia Chromosome Positive Chronic Myelogenous Leukemia Studies:
1. Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

2. Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission

3. Monoclonal Antibody Therapy, Cyclophosphamide, and Total-Body Irradiation Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Recurrent Acute Lymphocytic Leukemia

4. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

5. Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia

Related Studies:

Other Philadelphia chromosome positive chronic myelogenous leukemia Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials

Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
Modify your Search

  Other Philadelphia chromosome positive chronic myelogenous leukemia Clinical Trials
  Other Florida Clinical Trials
  Other Tampa 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