Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Clinical research trials and DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia. DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia clinical trial. Participants oftentimes recieve the finest healthcare available for their DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.

Home > "D" Clinical Trials Conditions > DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia

DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia



DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia

For Condition: recurrent adult acute myeloid leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Comprehensive Cancer Center of Wake Forest University
Synopsis: RATIONALE: DTGM fusion protein may be able to locate cancer cells and stop them from growing. PURPOSE: Phase I trial to study the effectiveness of DTGM fusion protein in treating patients who have recurrent or refractory acute myeloid leukemia.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of DTGM fusion protein in patients with recurrent or refractory adult acute myeloid leukemia. II. Determine the dose-limiting toxic effects of this regimen in these patients. III. Measure the pharmacokinetics of this treatment in these patients. IV. Evaluate the response rate and immune responses in patients treated with this regimen. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive DTGM fusion protein IV over 15 minutes on days 1-5. Cohorts of 3-6 patients receive escalating doses of DTGM fusion protein until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients with a partial response are eligible for retreatment. Patients are followed monthly until disease progression. PROJECTED ACCRUAL: Approximately 30-50 patients will be accrued for this study within 1.5 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically, morphologically, or cell surface marker confirmed, recurrent or refractory adult acute myeloid leukemia (AML); Must have received 1-3 prior induction therapies - No CNS leukemia --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; No concurrent chemotherapy; Recovered from prior chemotherapy - Endocrine therapy: Concurrent corticosteroids allowed - Radiotherapy: No concurrent radiotherapy; Recovered from prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: CALGB 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: WBC less than 30,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST or ALT less than 5 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: Cardiac ejection fraction at least 50% normal; No myocardial infarction within the past 6 months - Pulmonary: FEV1 at least 70% normal - Other: No concurrent serious medical problems, uncontrolled infections, or psychiatric disorders; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception; No history of severe penicillin allergy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ArthurFrankel,  Study Chair,  Comprehensive Cancer Center of Wake Forest University

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem,  North Carolina,  27157-1082
United States
 


Additional Information:
Study ID Numbers:  CDR0000066998;  CCCWFU-22300,NCI-H99-0027,CCCWFU-22198,CCCWFU-IND-8153
Study Start Date: March 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003840

Other Recurrent Adult Acute Myeloid Leukemia Studies:
1. Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia

2. Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia

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

4. Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma

5. Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia

Related Studies:

Other recurrent adult acute myeloid leukemia Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials

DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia
Modify your Search

  Other recurrent adult acute myeloid leukemia Clinical Trials
  Other North Carolina Clinical Trials
  Other Winston Salem 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