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Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
This study has been completed.
Study NCT00003174   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes

November 1, 1999
July 23, 2008
May 1998
 
 
 
Complete list of historical versions of study NCT00003174 on ClinicalTrials.gov Archive Site
 
 
 
Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Phase I Clinical Evaluation of Bryostatin 1 in Combination With 2-CdA in Patients With Relapsed CLL

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of cladribine when given with bryostatin 1 in treating patients with relapsed chronic lymphocytic leukemia.

OBJECTIVES:

  • Determine the maximum tolerated dose of cladribine when administered after bryostatin 1 in patients with relapsed chronic lymphocytic leukemia.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of cladribine.

Patients receive bryostatin 1 IV continuously on days 1-3 immediately followed by cladribine IV continuously on days 4-8. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR.

Cohorts of 3-6 patients receive escalating dose levels of cladribine 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 at 3 weeks.

PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.

Phase I
Interventional
Treatment
Leukemia
  • Drug: bryostatin 1
  • Drug: cladribine
 
Ahmad I, Al-Katib AM, Beck FW, Mohammad RM. Sequential treatment of a resistant chronic lymphocytic leukemia patient with bryostatin 1 followed by 2-chlorodeoxyadenosine: case report. Clin Cancer Res. 2000 Apr;6(4):1328-32.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Diagnosis of relapsed chronic lymphocytic leukemia

    • Intermediate- or high-risk (stage I-IV) disease
  • Intermediate-risk patients must have active disease, defined by at least 1 of the following criteria:

    • Presence of any 1 of the following disease-related B symptoms:

      • 10% or more loss of body weight within the past 6 months
      • Extreme fatigue
      • Fever greater than 100 degrees Fahrenheit without evidence of infection
      • Night sweats
    • Massive (greater than 6 cm below left costal margin) or progressive splenomegaly
    • Massive (greater than 10 cm in longest diameter) or progressive lymphadenopathy
    • Progressive lymphocytosis with an increase of more than 50% over a 2-month period or anticipated doubling time of less than 12 months
    • Progressive bone marrow failure as manifested by the development or worsening of anemia and/or thrombocytopenia
    • Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids
  • Failed 1-2 prior front-line regimens
  • Failed prior fludarabine
  • Ineligible for any known treatment of higher potential efficacy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • See Disease Characteristics
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 50,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • Transaminases less than 2.5 times normal

Renal:

  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No history of severe coronary artery disease, cardiomyopathy, uncontrolled congestive heart failure, or arrhythmias

Neurologic:

  • No prior drug-related neurotoxicity
  • No other neurologic disorder

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective barrier or non-hormonal contraception during and for 2 months after study participation
  • No HIV infection
  • No AIDS

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior bone marrow transplantation

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and recovered

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent steroids
  • No concurrent hormonal contraceptives

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • No other concurrent therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003174
 
CDR0000065984, WSU-C-1388, NCI-T97-0016
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Ayad M. Al-Katib, MD, FACP Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP