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

NCT00019838 | Completed Phase 1

• 3 other identifiers: CDR0000067252NCI-99-C-0127NCI-T99-0022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Interventions

7-hydroxystaurosporine DRUG

fludarabine phosphate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• 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.

  PMID: 21745173 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Leukemia; Lymphoma; Waldenstrom Macroglobulinemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Hairy Cell; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone

Interventions

7-hydroxystaurosporine; fludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Study Officials

• Wyndham H. Wilson, MD, PhD

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 1999
• Last Updated: April 29, 2015

Record last verified: 2005-02

Locations

US (2)