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Sponsors and Collaborators: |
University of Maryland Greenebaum Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00301938 |
RATIONALE: UCN-01 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as perifosine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving UCN-01 together with perifosine may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of UCN-01 when given together with perifosine in treating patients with relapsed or refractory acute leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: 7-hydroxystaurosporine Drug: perifosine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase 1 Study of UCN-01 in Combination With Perifosine in Patients With Relapsed and Refractory Acute Leukemias and High Risk MDS |
Estimated Enrollment: | 30 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of UCN-01. The first patients enrolled in the study are assigned to group 1. Once the maximum tolerated dose (MTD) is determined in group 1, subsequent patients are enrolled in group 2.
Cohorts of 3-6 patients receive escalating doses of UCN-01 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
In both groups, treatment repeats every 28 days for ≥ 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete remission (CR) or a CR with incomplete hematologic recovery receive 4 additional courses beyond documentation of CR. Patients who achieve a partial remission or hematologic improvement may continue treatment in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 30 days and then periodically thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed hematologic malignancy of 1 of the following types:
Relapsed or refractory acute myelogenous leukemia (AML)
Patients with acute promyelocytic leukemia t(15;17) are eligible provided they failed a prior tretinoin and arsenic-containing regimen
Chronic myelogenous leukemia (CML) in accelerated or blastic phase that is refractory to imatinib mesylate
De novo AML or pre-B-cell or T-cell ALL in adults > 60 years of age with poor-risk features, such as complex (≥ 3) or adverse cytogenetics
The following are considered adverse cytogenetic abnormalities for AML:
The following are considered adverse cytogenetic abnormalities for ALL:
Myelodysplastic Syndromes (MDS) meeting 1 of the following criteria:
Intermediate 2 and high risk MDS without 5q- cytogenetic abnormality that is refractory or has progressed after azacitidine or decitabine
PATIENT CHARACTERISTICS:
No active, uncontrolled infection
LVEF ≥ 40% by echocardiogram or MUGA
PRIOR CONCURRENT THERAPY:
At least 90 days since prior allogeneic SCT
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 |
Principal Investigator: | Ivana Gojo, MD | University of Maryland Greenebaum Cancer Center |
Study ID Numbers: | CDR0000465368, MSGCC-0507, MSGCC-H-27229-0507, NCI-7311 |
Study First Received: | March 9, 2006 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00301938 History of Changes |
Health Authority: | Unspecified |
accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia recurrent adult acute lymphoblastic leukemia T-cell adult acute lymphoblastic leukemia adult acute myeloid leukemia with t(15;17)(q22;q12) secondary acute myeloid leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) 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) 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) recurrent adult acute myeloid leukemia adult acute promyelocytic leukemia (M3) untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia myelodysplastic/myeloproliferative diseases previously treated myelodysplastic syndromes |
Leukemia, Monocytic, Acute Blast Crisis Leukemia, Lymphoid Precancerous Conditions Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Protein Kinase Inhibitors Leukemia Acute Erythroblastic Leukemia Preleukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Staurosporine Leukemia, Promyelocytic, Acute |
Neoplasm Metastasis Congenital Abnormalities Myelodysplastic Myeloproliferative Disease Acute Lymphoblastic Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders 7-hydroxystaurosporine Leukemia, Myeloid Recurrence Leukemia, Myelomonocytic, Acute Leukemia, Erythroblastic, Acute Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
Disease Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Enzyme Inhibitors 7-hydroxystaurosporine Leukemia, Myeloid Protein Kinase Inhibitors |
Pharmacologic Actions Leukemia Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Staurosporine Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases |