Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

NCT00003174 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000065984P30CA022453WSU-C-1388NCI-T97-0016
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Leukemia

Keywords

stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; refractory chronic lymphocytic leukemia

Interventions

bryostatin 1 DRUG

cladribine DRUG

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48202-1379, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Related Publications (1)

• 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.

  PMID: 10778958 BACKGROUND

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

bryostatin 1; Cladribine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Ayad M. Al-Katib, MD, FACP

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: May 1, 1998
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

US (3)