Assessing Arsenic Trioxide in Young Patients With Leukemia or Lymphoma Who Were Treated on Clinical Trial NCI-00-C-0070J
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Purpose
RATIONALE: Studying bone marrow and blood samples from patients with leukemia or lymphoma treated with arsenic trioxide may help doctors learn more about cancer.
PURPOSE: This research study is assessing arsenic trioxide in young patients with recurrent or refractory leukemia or lymphoma who were treated on clinical trial NCI-00-C-0070J.
| Condition | Intervention |
|---|---|
|
Leukemia Lymphoma |
Other: pharmacological study |
| Study Type: | Observational |
| Official Title: | Sample Analysis for Terminated Protocol 00-C-0070, Pediatric Phase I Trial of Arsenic Trioxide |
- Pharmacokinetics (PK) [ Designated as safety issue: No ]
- Pharmacodynamics (PD) [ Designated as safety issue: No ]
- Correlation of PK and PD with clinical parameters, such as age, gender, and dose [ Designated as safety issue: No ]
| Estimated Enrollment: | 23 |
| Study Completion Date: | February 2008 |
OBJECTIVES:
- To assess the pharmacokinetic and pharmacodynamic profiles of arsenic trioxide in pediatric patients treated on protocol NCI-00-C-0070J.
OUTLINE: Bone marrow or peripheral blood mononuclear cells collected during treatment on NCI-00-C-0070J are assessed for pharmacodynamics studies. Plasma cells collected during treatment are assessed for pharmacokinetics studies. Total arsenic (As), inorganic As forms (AsIII and AsV), and methylated metabolites of As are assessed.
Eligibility| Ages Eligible for Study: | 2 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens
- No meningeal leukemia or lymphoma
- No HIV-related lymphoma
- No lymphoproliferative diseases
- Received treatment on protocol NCI-00-C-0070J
- Bone marrow or peripheral blood and serum samples collected during treatment on NCI-00-C-0070J are available
PATIENT CHARACTERISTICS:
- See NCI-00-C-0070J
PRIOR CONCURRENT THERAPY:
- See NCI-00-C-0070J
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00899015 History of Changes |
| Other Study ID Numbers: | 999907221, 07-C-N221, CDR0000570658 |
| Study First Received: | May 9, 2009 |
| Last Updated: | March 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
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, BCR-ABL1 negative |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Arsenic trioxide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013