|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Princess Margaret Hospital, Canada |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00045513 |
Purpose
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 |
|---|---|---|
|
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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000256600, PMH-PHL-006, NCI-5538 |
| Study First Received: | September 6, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00045513 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory chronic lymphocytic leukemia recurrent small lymphocytic lymphoma |
|
Antimetabolites Anti-Infective Agents Vidarabine Leukemia, Lymphoid Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Protein Kinase Inhibitors Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Staurosporine Lymphoma |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Enzyme Inhibitors Fludarabine monophosphate 7-hydroxystaurosporine Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Fludarabine Lymphoproliferative Disorders Leukemia, B-Cell |