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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00003174
First received: November 1, 1999
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: bryostatin 1
Drug: cladribine
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Clinical Evaluation of Bryostatin 1 in Combination With 2-CdA in Patients With Relapsed CLL

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Estimated Enrollment: 80
Study Start Date: May 1998
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003174

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48202-1379
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Ayad M. Al-Katib, MD, FACP Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003174     History of Changes
Other Study ID Numbers: CDR0000065984, P30CA022453, WSU-C-1388, NCI-T97-0016
Study First Received: November 1, 1999
Last Updated: April 22, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bryostatin 1
Cladribine
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014