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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: | NCT00933985 |
RATIONALE: Obatoclax mesylate may stop the growth of cancer cells by blocking some of the proteins needed for cell growth and causing the cells to self-destruct. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of obatoclax mesylate when given together with vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane hydrochloride in treating young patients with relapsed or refractory solid tumors, lymphoma, or leukemia.
Condition | Intervention | Phase |
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Leukemia Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: obatoclax mesylate Drug: vincristine sulfate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study of Obatoclax (Pan Anti-Apoptotic BCL-2 Family Small Molecule Inhibitor), in Combination With Vincristine/Doxorubicin/Dexrazoxane, in Children With Relapsed/Refractory Solid Tumors or Leukemia |
Estimated Enrollment: | 52 |
Study Start Date: | June 2009 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of obatoclax mesylate. Patients are stratified according to disease type (solid tumor or lymphoma [stratum 1] vs multilineage leukemia (MLL) [stratum 2] vs non-MLL leukemia [stratum 3]) and treated according to stratum.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Histologically confirmed refractory or relapsed solid tumor or lymphoma (stratum 1)
Recurrent or refractory mixed-lineage leukemia (MLL) leukemia (stratum 2)
Recurrent or refractory non-MLL leukemia (stratum 3)
PATIENT CHARACTERISTICS:
Creatinine clearance OR radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
Adequate cardiac function defined as 1 of the following:
Central nervous system function defined as:
PRIOR CONCURRENT THERAPY:
At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
At least 7 days since prior biologic therapy
Prior radiotherapy allowed according to the following criteria:
No other concurrent anticancer agents (including chemotherapy, radiotherapy, immunotherapy, or biologic therapy) except for hydroxyurea
United States, Alabama | |
UAB Comprehensive Cancer Center | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309 | |
United States, California | |
Children's Hospital of Orange County | Recruiting |
Orange, California, United States, 92868 | |
Contact: Violet Shen 714-532-8636 | |
United States, Illinois | |
Children's Memorial Hospital - Chicago | Recruiting |
Chicago, Illinois, United States, 60614 | |
Contact: Stewart Goldman 773-880-4598x3270 | |
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, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Robert J. Hayashi 314-454-4118 | |
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 513-636-2799 |
Study Chair: | Richard Aplenc, MD, MSCE | Children's Hospital of Philadelphia |
Responsible Party: | Dan L. Duncan Cancer Center at Baylor College of Medicine ( Susan M. Blaney ) |
Study ID Numbers: | CDR0000647160, COG-ADVL0816 |
Study First Received: | July 7, 2009 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00933985 History of Changes |
Health Authority: | Unspecified |
unspecified childhood solid tumor, protocol specific recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia secondary acute myeloid leukemia acute undifferentiated leukemia relapsing chronic myelogenous leukemia childhood chronic myelogenous leukemia blastic phase chronic myelogenous leukemia recurrent childhood anaplastic large cell lymphoma |
recurrent childhood grade III lymphomatoid granulomatosis recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma recurrent/refractory childhood Hodgkin lymphoma Burkitt lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent cutaneous T-cell non-Hodgkin lymphoma cutaneous B-cell non-Hodgkin lymphoma |
Blast Crisis Razoxane Mycoses Acute Myelocytic Leukemia Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Vincristine Leukemia, Myeloid Doxorubicin B-cell Lymphomas Chronic Myelogenous Leukemia |
Chelating Agents Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Lymphoma, T-Cell, Cutaneous Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Hodgkin Lymphoma, Childhood Sezary Syndrome Mycosis Fungoides Leukemia, Myeloid, Acute Lymphoblastic Lymphoma Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia Anti-Bacterial Agents |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Mitosis Modulators Vincristine Antimitotic Agents Cardiovascular Agents Antibiotics, Antineoplastic Pharmacologic Actions |
Doxorubicin Razoxane Leukemia Lymphatic Diseases Neoplasms Therapeutic Uses Tubulin Modulators Chelating Agents Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic Lymphoma |