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Sponsored by: |
National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020111 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide in treating young patients with leukemia or lymphoma.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Drug: arsenic trioxide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial and Pharmacokinetic Study of Arsenic Trioxide in Pediatric Patients With Refractory Leukemia or Lymphoma |
Study Start Date: | March 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to disease (acute promyelocytic leukemia [APL] vs non-APL).
Leukemia patients in both strata without progressive disease who have not achieved complete remission after the first 20 doses may continue to receive arsenic trioxide for 2 additional weeks.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for stratum I of this study within 2-3 years. A total of 3-30 patients will be accrued for stratum II of this study within 1-2 years.
Ages Eligible for Study: | 2 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
2 to 21
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Frank M. Balis, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000067717, NCI-00-C-0070J, NCI-T99-0080 |
Study First Received: | July 11, 2001 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00020111 |
Health Authority: | United States: Federal Government |
recurrent childhood acute myeloid leukemia childhood acute promyelocytic leukemia (M3) recurrent childhood acute lymphoblastic leukemia recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma |
recurrent childhood small noncleaved cell lymphoma recurrent/refractory childhood Hodgkin lymphoma childhood chronic myelogenous leukemia atypical chronic myeloid leukemia |
Leukemia, Lymphoid Hodgkin's disease Chronic myelogenous leukemia Leukemia, Myeloid, Acute Small non-cleaved cell lymphoma Lymphoma, large-cell Leukemia Leukemia, Promyelocytic, Acute Hodgkin Disease Lymphoma Acute myelocytic leukemia Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Immunoproliferative Disorders Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Acute myelogenous leukemia Acute promyelocytic leukemia Arsenic trioxide Leukemia, Myeloid Lymphoblastic lymphoma Recurrence Lymphatic Diseases Hodgkin lymphoma, childhood Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoproliferative Disorders |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |