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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00588991 |
Purpose
RATIONALE: ABT-888 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with topotecan and carboplatin may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of ABT-888 when given together with topotecan with or without carboplatin in treating patients with relapsed or refractory acute leukemia, high-risk myelodysplasia, or aggressive myeloproliferative disorders.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Myelodysplastic Syndromes |
Drug: ABT-888 Drug: carboplatin Drug: topotecan hydrochloride Other: pharmacological study |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase 1 Study of ABT-888 in Combination With Topotecan Plus Carboplatin for Relapsed and Refractory Acute Leukemias and High-Risk Myelodyplasias and Myeloproliferative Disorders |
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of ABT-888.
Patients receive oral ABT-888 twice daily on days 1-8 and topotecan hydrochloride with or without carboplatin IV continuously over 120 hours on days 3-7. Treatment repeats every 28-63 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for pharmacokinetic studies.
After completion of study therapy, patients are followed for 30 days.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed diagnosis of 1 of the following:
Acute myeloid leukemia, acute lymphoblastic leukemia, or high-risk myelodysplastic syndromes that has relapsed at least once or is refractory, including primary induction failure
Aggressive phase high-risk myeloproliferative disorders (i.e., polycythemia vera , essential thrombocythemia, or Ph-negative chronic myelogenous leukemia) meeting ≥ 1 of the following criteria:
Chronic myelomonocytic leukemia meeting either of the following criteria:
PATIENT CHARACTERISTICS:
No active uncontrolled infection
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior autologous or allogeneic stem cell transplantation
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231-2410 | |
| Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
| Study Chair: | Judith E. Karp, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000579626, JHOC-J0783 |
| Study First Received: | December 20, 2007 |
| Last Updated: | December 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00588991 History of Changes |
| Health Authority: | Unspecified |
|
recurrent adult acute lymphoblastic leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes essential thrombocythemia Philadelphia chromosome negative chronic myelogenous leukemia polycythemia vera |
chronic myelomonocytic leukemia adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) relapsing chronic myelogenous leukemia |
|
Disease Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Enzyme Inhibitors Carboplatin |
Pharmacologic Actions Leukemia Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Topotecan Bone Marrow Diseases |