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Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045513 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining UCN-01 with fludarabine in treating patients who have relapsed or refractory chronic lymphocytic leukemia or lymphocytic lymphoma.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: 7-hydroxystaurosporine Drug: fludarabine phosphate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study Of UCN-01 In Combination With Fludarabine In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma |
Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of UCN-01.
Patients receive UCN-01 IV over 3 hours on day 1 and fludarabine IV over 30-60 minutes on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 18-46 additional patients receive UCN-01 and fludarabine as above at the recommended phase II dose.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for the phase I portion of this study within 6 months. A total of 18-46 patients will be accrued for the phase II portion of this study within 9-23 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) or B-cell small lymphocytic lymphoma (SLL)
CLL is defined as:
Refractory to or disease progression after 1 or 2 prior treatment regimens
Retreatment with oral chlorambucil is allowed and considered a second regimen
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Canada, Ontario | |
London Health Sciences Centre | |
London, Ontario, Canada, N6A 465 | |
McMaster Children's Hospital at Hamilton Health Sciences | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Princess Margaret Hospital at University Health Network | |
Toronto, Ontario, Canada, M5G 2M9 |
Study Chair: | Michael R. Crump, MD, FRCPC | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000256600, PMH-PHL-006, NCI-5538 |
Study First Received: | September 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00045513 |
Health Authority: | United States: Federal Government |
refractory chronic lymphocytic leukemia recurrent small lymphocytic lymphoma |
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, B-cell, chronic 7-hydroxystaurosporine Fludarabine monophosphate Recurrence Leukemia |
Lymphatic Diseases Leukemia, Lymphocytic, Chronic, B-Cell Staurosporine Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses |