Combination Chemotherapy in Treating Children With Relapsed Acute Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT00002499|
Recruitment Status : Unknown
Verified May 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 23, 2004
Last Update Posted : September 20, 2013
|First Submitted Date ICMJE||November 1, 1999|
|First Posted Date ICMJE||August 23, 2004|
|Last Update Posted Date||September 20, 2013|
|Study Start Date ICMJE||January 1990|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00002499 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Combination Chemotherapy in Treating Children With Relapsed Acute Lymphocytic Leukemia|
|Official Title ICMJE||TREATMENT OF ALL IN FIRST BONE MARROW RELAPSE AFTER BFM PROTOCOLS|
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II/III trial to study the effectiveness of combination chemotherapy in treating children with relapsed acute lymphocytic leukemia.
OBJECTIVES: I. Evaluate the feasibility, at GATLA, of a study of the treatment of ALL in first hematologic relapse following treatment on a BFM protocol. II. Evaluate the efficacy of induction with vincristine/daunorubicin/asparaginase/prednisone in producing a second complete remission in these patients, and evaluate the toxicity of this regimen. III. Evaluate the efficacy and toxicity of the Capizzi I regimen (vincristine/asparaginase/methotrexate) and Capizzi II regimen (cytarabine/asparaginase/daunorubicin) when given to maintain and prolong complete remission. IV. Offer the option of bone marrow transplantation to those patients who are in second remission and who have a histocompatible donor, and compare outcome of these patients with those on chemotherapy alone.
OUTLINE: Nonrandomized study. Patients achieving remission on Induction proceed to Interim Maintenance, then to Continued Maintenance; those failing to achieve remission receive Salvage Re-induction, followed, if remission is achieved, by Interim Maintenance, then Continued Maintenance. Induction: 4-Drug Combination Chemotherapy with CNS Prophylaxis/Therapy. Vincristine, VCR, NSC-67574; Prednisone, PRED, NSC-10023; Asparaginase, ASP, NSC-109229; Daunorubicin, DNR, NSC-82151; with Intrathecal Cytarabine, IT ARA-C, NSC-63878; Intrathecal Dexamethasone, IT DM, NSC-34521. Interim Maintenance: 3-Drug Combination Chemotherapy with, as indicated, Radiotherapy. VCR; ASP; Methotrexate, MTX, NSC-740; with, as indicated, testicular irradiation (equipment not specified). Continued Maintenance: 3-Drug Combination Chemotherapy followed by 3-Drug Combination Chemotherapy with CNS Prophylaxis and, as indicated, Radiotherapy. Capizzi II: ARA-C; ASP; DNR; followed by Capizzi I: VCR; ASP; MTX; with IT ARA-C; IT DM; and, as indicated, cranial irradiation (equipment not specified). Salvage Re-induction: 2-Drug Combination Chemotherapy. ARA-C; ASP.
PROJECTED ACCRUAL: At least 72 evaluable patients will be entered. Accrual is expected to be completed in 3 years.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2
|Study Design ICMJE||Primary Purpose: Treatment|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Enrollment ICMJE||Not Provided|
|Original Enrollment ICMJE||Not Provided|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: ALL in first hematologic relapse during or following completion of treatment on a BFM protocol (ARG-GATLA-1-LLA-82, -84, -87, or -90) M2-M3 bone marrow required
PATIENT CHARACTERISTICS: Age: Under 20 Performance status: Not specified Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: No significant liver disease Renal: No significant kidney disease Cardiovascular: No significant heart disease Pulmonary: No significant lung disease Other: No significant digestive disease
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior total anthracycline no greater than 280 mg/sqm Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not applicable
|Ages||up to 19 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Argentina|
|Removed Location Countries|
|NCT Number ICMJE||NCT00002499|
|Other Study ID Numbers ICMJE||CDR0000077835
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Grupo Argentino de Tratamiento de la Leucemia Aguda|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||May 2000|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP