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Combination Chemotherapy in Treating Children With Relapsed Acute Lymphocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002499
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: May 2000

November 1, 1999
September 19, 2013
January 1990
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Complete list of historical versions of study NCT00002499 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy in Treating Children With Relapsed Acute Lymphocytic Leukemia
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.

Interventional
Phase 2
Phase 3
Primary Purpose: Treatment
Leukemia
  • Drug: asparaginase
  • Drug: cytarabine
  • Drug: daunorubicin hydrochloride
  • Drug: dexamethasone
  • Drug: methotrexate
  • Drug: prednisone
  • Drug: vincristine sulfate
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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

Both
up to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00002499
CDR0000077835, ARG-GATLA-1LLAREC90, NCI-F92-0006
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Grupo Argentino de Tratamiento de la Leucemia Aguda
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Study Chair: Federico Sackmann-Muriel, MD Hospital de Pediatria Garrahan
National Cancer Institute (NCI)
May 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP