CINJALL: Treatment for Children With Acute Lymphocytic Leukemia
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Purpose
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 those patients at higher risk for certain side effects, as well as those who are at higher risk for relapse of their leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphocytic Leukemia |
Drug: aminopterin Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunomycin Drug: dexamethasone Drug: hydrocortisone Drug: 6-mercaptopurine Drug: methotrexate Drug: 6-thioguanine Drug: vincristine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CINJALL: Treatment for Children With Acute Lymphocytic Leukemia |
- The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (ALL). [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- To measure 5-methytltetrahydrofolate, aminopterin and methotrexate uptake in leukemic blasts isolated at diagnosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 64 |
| Study Start Date: | February 2001 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
-
Drug: aminopterin
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 half years.
Therapy will be divided into five phases:
Induction (4 weeks): chemotherapy given to produce a clinical remission (defined by normal blood counts, with the absence of leukemia cells in the blood and fewer than 5% leukemia cells in the bone marrow).
Consolidation (11 weeks): chemotherapy given to consolidate the remission. Delayed Intensification (7 weeks) Intensive chemotherapy aimed at killing any resistant leukemia cells will be given only for patients at high risk of relapse.
Intensive Continuation (approximately 1 year): Eight week cycles of chemotherapy, given eight times.
Continuation (final year of therapy): Eight week cycles of largely oral chemotherapy, with one clinic visit for a lumbar puncture every eight weeks.
Irradiation: radiation will be given in the middle of intensive continuation to the head and spine of those patients who have leukemia cells found in the cerebrospinal fluid at the time of diagnosis.
Follow-up: After the conclusion of therapy, there will be periodic office visits, initially monthly, then gradually spaced out to annual visits. The purpose of these visits is to evaluate for late side-effects of therapy.
Eligibility| Ages Eligible for Study: | 1 Year to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion/Exclusion Criteria:
Newly Diagnosed ALL, excluding mature B-cell ALL (surface Ig positive) Patients with overt CNS or testicular disease are eligible Informed consent according to institutional and FDA guidelines. Adequate organ function is required. 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.
HIV seropositive patients will not be excluded from this study. Patients with medical, psychological, or psychiatric problems that are likely to compromise their ability to tolerate intensive therapy will be ineligible. Any questions about the appropriateness of patient for this study should be directed to the Principal Investigator.
Patients greater than 1 year of age and less than 29.99 years of age are eligible.
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| Principal Investigator: | Peter Cole, MD | University of Medicine and Dentistry New Jersey |
More Information
No publications provided
| Responsible Party: | Barton Kamen, UMDNJ |
| ClinicalTrials.gov Identifier: | NCT00176462 History of Changes |
| Other Study ID Numbers: | 020101-0220003389, CINJ#020101 |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 10, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
Acute Lymphocytic Leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Cytarabine Methotrexate Thioguanine Cyclophosphamide Asparaginase |
Daunorubicin Dexamethasone Vincristine Aminopterin BB 1101 Dexamethasone acetate Cortisol succinate Hydrocortisone acetate Hydrocortisone 17-butyrate 21-propionate Hydrocortisone Dexamethasone 21-phosphate Hydrocortisone-17-butyrate Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013