Status:
COMPLETED
CINJALL: Treatment for Children With Acute Lymphocytic Leukemia
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Lymphocytic Leukemia
Eligibility:
All Genders
1-30 years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (ALL). At the same time, doctors hope to define methods to identify tho...
Detailed Description
Outline of Therapy: Combinations of chemotherapy drugs will be given orally, intravenously and intrathecally (directly into the cerebrospinal fluid by spinal tap) over a period of roughly two and a h...
Eligibility Criteria
Inclusion
- Inclusion:
- Newly Diagnosed ALL, excluding mature B-cell ALL (surface Ig positive)
- Patients with overt CNS (central nervous system) or testicular disease are eligible
- Informed consent according to institutional and FDA guidelines.
- Adequate organ function is required.
- HIV seropositive patients will not be excluded from this study.
- Patients greater than 1 year of age and less than 29.99 years of age are eligible.
- Exclusion Criteria
- Patients with medical, psychological, or psychiatric problems that are likely to compromise their ability to tolerate intensive therapy will be ineligible.
- All patients with evidence of significant organ dysfunction not thought to be attributable to ALL (patients with clinically significant congestive heart failure, cardiac ejection fraction \<40%, total bilirubin \>2, serum creatinine \>2) will be ineligible. Note: echocardiogram or MUGA are required prior to therapy ONLY for those patients with history or physical findings suggestive of cardiac dysfunction not directly attributable to anemia or ALL. Note: Patients with total bilirubin \>2 but direct (conjugated) bilirubin less than the upper limit of normal will still be eligible. These patients should be evaluated for deficiency of the enzyme glucuronyl transferase.
Exclusion
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00176462
Start Date
February 1 2001
End Date
September 1 2008
Last Update
June 9 2014
Active Locations (2)
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1
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07754
2
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903