Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Clinical research trials and Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia. Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia clinical trial. Human subjects often receive the most effective healthcare possible for their Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia



Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

For Condition: recurrent childhood acute myeloid leukemia,recurrent adult acute lymphoblastic leukemia,recurrent adult acute myeloid leukemia,recurrent childhood acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): Roswell Park Cancer 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. Colony-stimulating factors such as filgrastim and sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether combination chemotherapy is more effective followed by filgrastim or sargramostim in treating leukemia. PURPOSE: Randomizedphase II trial to compare the effectiveness of combination chemotherapy followed by filgrastim with that of combination chemotherapy followed by sargramostim in treating patients who have relapsed or refractoryacute myeloid leukemia or acute lymphoblastic leukemia.
Details: OBJECTIVES: - Compare amounts of dendritic cells and leukemia-associated antigen-specific T lymphocytes in patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with filgrastim (G-CSF) vs sargramostim (GM-CSF) after high-dose cytarabine and mitoxantrone. OUTLINE: This is a randomized study. All patients receive high-dose cytarabine IV over 1 hour twice daily on days 1-6 and mitoxantrone IV over 30 minutes on days 2-4. On day 6, patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover in the absence of unacceptable toxicity. - Arm II: Patients receive sargramostim (GM-CSF) SC daily as in arm I. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 6 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia by morphology, cytochemical staining, and flow cytometry - In first or subsequent relapse or refractory disease after at least 1 prior treatment regimen - Antecedent hematologic disorders allowed except Philadelphia chromosome-positive chronic myelogenous leukemia PATIENT CHARACTERISTICS: Age - 15 and over Performance status - 0-3 Life expectancy - At least 4 weeks Hematopoietic - Not specified Hepatic - Bilirubin no greater than 2 times normal* - SGOT no greater than 2 times normal* NOTE: *Unless directly attributable to leukemia Renal - Creatinine no greater than 1.5 times normal* NOTE: *Unless directly attributable to leukemia Cardiovascular - Ejection fraction at least 45%* NOTE: *Unless directly attributable to leukemia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other concurrent medical or psychiatric illness that would preclude study entry PRIOR CONCURRENT THERAPY: Biologic therapy - Prior autologous or allogeneic bone marrow or peripheral blood stem cell transplantation allowed - Prior cytokines allowed Chemotherapy - Prior chemotherapy allowed Endocrine therapy - No concurrent corticosteroids except for treatment of severe vomiting that is refractory to standard agents Radiotherapy - Prior radiotherapy allowed Surgery - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MariaBaer,  Study Chair,  Roswell Park Cancer Institute

Roswell Park Cancer Institute
Buffalo,  New York,  14263-0001
United States
 


Additional Information:
Study ID Numbers:  CDR0000269285;  RPCI-RPC-9902
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053131

Other Recurrent Adult Acute Myeloid Leukemia Studies:
1. Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation

2. Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

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

4. 506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

5. 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies

Related Studies:

Other recurrent adult acute myeloid leukemia Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials

Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Modify your Search

  Other recurrent adult acute myeloid leukemia Clinical Trials
  Other New York Clinical Trials
  Other Buffalo 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