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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00096135 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS and/or testes.
| Condition | Intervention |
|---|---|
|
Leukemia |
Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: therapeutic hydrocortisone Drug: vincristine sulfate Radiation: radiation therapy |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Treatment of Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months) |
| Estimated Enrollment: | 257 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 1 Year to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute lymphoblastic leukemia
First isolated CNS and/or testicular relapse
Isolated CNS relapse, as defined by 1 of the following:
Any number of WBC in CSF with immunophenotypic proof of leukemic relapse, defined by the following:
Identifiable blasts AND 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine adjusted according to age as follows:
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 143 Study Locations| Study Chair: | Julio C. Barredo, MD | Medical University of South Carolina |
| Investigator: | Caroline A. Hastings, MD | Children's Hospital and Research Center Oakland |
More Information
| Study ID Numbers: | CDR0000390345, COG-AALL02P2 |
| Study First Received: | November 9, 2004 |
| Last Updated: | February 6, 2010 |
| ClinicalTrials.gov Identifier: | NCT00096135 History of Changes |
| Health Authority: | Unspecified |
|
recurrent childhood acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia T-cell childhood acute lymphoblastic leukemia TdT positive childhood acute lymphoblastic leukemia |
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Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Hydrocortisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Hormones Pegaspargase Therapeutic Uses Abortifacient Agents Methotrexate |
Dermatologic Agents Etoposide Nucleic Acid Synthesis Inhibitors Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Neoplasms Hydrocortisone acetate Antineoplastic Agents, Phytogenic Antimetabolites Daunorubicin |