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Phase I Clinical Evaluation of Bryostatin 1 in Combination With 2-CdA in Patients With Relapsed CLL


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Phase I Clinical Evaluation of Bryostatin 1 in Combination With 2-CdA in Patients With Relapsed CLL


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ayad M. Al-Katib, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000065984

NCT ID:

NCT00003174

Start Date:

May 1998

Completion Date:

Related Keywords:

  • Leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202