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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00873093 |
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or acute lymphoblastic lymphoma.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Biological: filgrastim Drug: asparaginase Drug: bortezomib Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide phosphate Drug: leucovorin calcium Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Pilot Trial of Bortezomib (PS-341, Velcade®, IND #58,443) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) |
Estimated Enrollment: | 60 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients with persistent CSF blasts after 6 doses of TIT or patients with progressive acute lymphoblastic lymphoma are removed from the study.
NOTE: *Patients do not receive G-CSF on day 8.
Ages Eligible for Study: | 1 Year to 31 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
T-cell acute lymphoblastic lymphoma in first relapse as documented by histology
No Ph+ ALL unless refractory to ≥ 1 tyrosine kinase inhibitor therapy
No known optic nerve and/or retinal involvement
PATIENT CHARACTERISTICS:
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR maximum serum creatinine based on age/gender as follows:
Able to receive asparaginase (i.e., no prior severe pancreatitis, stroke, or other toxicity)
PRIOR CONCURRENT THERAPY:
No prior reinduction attempts or treatment for prior extramedullary relapse
At least 4 months since prior stem cell transplant or rescue
No concurrent anticonvulsants known to activate the cytochrome p450 system (e.g., phenytoin, carbamazepine, and phenobarbital)
United States, California | |
Children's Hospital Central California | Recruiting |
Madera, California, United States, 93638-8762 | |
Contact: Vonda L. Crouse 559-353-5480 | |
Children's Hospital of Orange County | Recruiting |
Orange, California, United States, 92868 | |
Contact: Violet Shen 714-532-8636 | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
United States, Florida | |
Lee Cancer Care of Lee Memorial Health System | Recruiting |
Fort Myers, Florida, United States, 33901 | |
Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt 877-680-0008 | |
United States, Indiana | |
Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202-5289 | |
Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552 | |
United States, Kentucky | |
Lucille P. Markey Cancer Center at University of Kentucky | Recruiting |
Lexington, Kentucky, United States, 40536-0093 | |
Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379 | |
United States, New York | |
SUNY Upstate Medical University Hospital | Recruiting |
Syracuse, New York, United States, 13210 | |
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229-3039 | |
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-0161 |
Study Chair: | Terzah M. Horton, MD, PhD | Texas Children's Cancer Center |
Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
Study ID Numbers: | CDR0000638413, COG-AALL07P1 |
Study First Received: | March 31, 2009 |
Last Updated: | May 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00873093 History of Changes |
Health Authority: | Unspecified |
B-cell childhood acute lymphoblastic leukemia B-cell adult acute lymphoblastic leukemia T-cell childhood acute lymphoblastic leukemia T-cell adult acute lymphoblastic leukemia |
recurrent childhood acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia recurrent childhood lymphoblastic lymphoma recurrent adult lymphoblastic lymphoma |
Anti-Inflammatory Agents Prednisone Hydrocortisone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pegaspargase Methotrexate Etoposide Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Vincristine Glucocorticoids |
Doxorubicin Protease Inhibitors Folic Acid Hydrocortisone acetate Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Acute Lymphoblastic Leukemia, Childhood Antimetabolites Leukemia, Lymphoid Immunologic Factors Leucovorin Cyclophosphamide Etoposide phosphate Lymphoblastic Lymphoma Leukemia |
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Hydrocortisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pegaspargase Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents Etoposide |
Nucleic Acid Synthesis Inhibitors Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Protease Inhibitors Neoplasms Hydrocortisone acetate Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic |