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UCN-01 and Fludarabine in Treating Patients With Recurrent or Refractory Lymphoma or Leukemia

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
7-hydroxystaurosporine
fludarabine phosphate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Waldenström macroglobulinemia, refractory chronic lymphocytic leukemia, refractory hairy cell leukemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory low-grade or indolent lymphoid malignancies requiring systemic therapy, including the following: Grade I or II follicular small cleaved cell lymphoma Small lymphocytic lymphoma/leukemia subtypes (chronic lymphocytic leukemia) Mantle cell lymphoma Waldenstrom's macroglobulinemia Lymphoplasmacytoid Marginal zone (nodal, extranodal, or splenic subtypes) Hairy cell leukemia Transformed indolent subtypes allowed provided 1 of the following criteria are met: Previously treated with a doxorubicin-containing regimen No rapidly progressing disease that threatens vital functions Measurable disease No active leptomeningeal or parenchymal CNS lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 50,000/mm^3 No active Coomb's-positive hemolytic anemia Hepatic: Total bilirubin less than 2.0 mg/dL (unless elevation is due to Gilbert's disease and direct bilirubin is normal) Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No angina No congestive heart failure No myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No insulin-dependent diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics More than 3 weeks since prior systemic chemotherapy and recovered Endocrine therapy: More than 3 weeks since prior systemic steroid therapy and recovered Radiotherapy: Not specified Surgery: Not specified

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • NCI - Center for Cancer Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
April 28, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00019838
Brief Title
UCN-01 and Fludarabine in Treating Patients With Recurrent or Refractory Lymphoma or Leukemia
Official Title
Phase I and Pharmacokinetic Study of UCN-01 and Fludarabine in Relapsed or Refractory Low-Grade Lymphoid Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2005
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when given with UCN-01 in treating patients with recurrent or refractory low-grade lymphoma or leukemia.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose and toxic effects of fludarabine when administered with UCN-01 in patients with recurrent or refractory low-grade or indolent lymphoid malignancies. Determine, preliminarily, the activity of this treatment regimen in these patients. Assess the pharmacokinetics of this treatment regimen in these patients. OUTLINE: This is a dose-escalation study of fludarabine. Patients receive UCN-01 IV over 72 hours on days 1-3 alone during course 1 and over 36 hours on days 1-2 during courses 2-7. Patients also receive fludarabine IV over 30 minutes beginning on day 1 and continuing for up to 5 days during courses 2-7. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of fludarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 2 months for 6 months, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
Waldenström macroglobulinemia, refractory chronic lymphocytic leukemia, refractory hairy cell leukemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
7-hydroxystaurosporine
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory low-grade or indolent lymphoid malignancies requiring systemic therapy, including the following: Grade I or II follicular small cleaved cell lymphoma Small lymphocytic lymphoma/leukemia subtypes (chronic lymphocytic leukemia) Mantle cell lymphoma Waldenstrom's macroglobulinemia Lymphoplasmacytoid Marginal zone (nodal, extranodal, or splenic subtypes) Hairy cell leukemia Transformed indolent subtypes allowed provided 1 of the following criteria are met: Previously treated with a doxorubicin-containing regimen No rapidly progressing disease that threatens vital functions Measurable disease No active leptomeningeal or parenchymal CNS lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 50,000/mm^3 No active Coomb's-positive hemolytic anemia Hepatic: Total bilirubin less than 2.0 mg/dL (unless elevation is due to Gilbert's disease and direct bilirubin is normal) Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No angina No congestive heart failure No myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No insulin-dependent diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics More than 3 weeks since prior systemic chemotherapy and recovered Endocrine therapy: More than 3 weeks since prior systemic steroid therapy and recovered Radiotherapy: Not specified Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wyndham H. Wilson, MD, PhD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
NCI - Center for Cancer Research
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21745173
Citation
Marti GE, Stetler-Stevenson M, Grant ND, White T, Figg WD, Tohnya T, Jaffe ES, Dunleavy K, Janik JE, Steinberg SM, Wilson WH. Phase I trial of 7-hydroxystaurosporine and fludararbine phosphate: in vivo evidence of 7-hydroxystaurosporine induced apoptosis in chronic lymphocytic leukemia. Leuk Lymphoma. 2011 Dec;52(12):2284-92. doi: 10.3109/10428194.2011.589547. Epub 2011 Jul 12.
Results Reference
result
Citation
Wilson WH, Gutierrez M, Stetler-Stevenson M, et al.: Phase I trial of 7-hydroxystaurosporine (UCN-01) and fludararbine phosphate (FAMP); in vivo evidence of UCN-01 induced apoptosis in CLL. [Abstract] Blood 96 (11 Pt 1): A-3268, 756a, 2000.
Results Reference
result

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UCN-01 and Fludarabine in Treating Patients With Recurrent or Refractory Lymphoma or Leukemia

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