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Phase I and Pharmacokinetic Study of UCN-01 and Fludarabine in Relapsed or Refractory Low-Grade Lymphoid Malignancies

Phase 1
18 Years
Not Enrolling
Leukemia, Lymphoma

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Trial Information

Phase I and Pharmacokinetic Study of UCN-01 and Fludarabine in Relapsed or Refractory Low-Grade Lymphoid Malignancies


- Determine the maximum tolerated dose and toxic effects of fludarabine when administered
with UCN-01 in patients with recurrent or refractory low-grade or indolent lymphoid

- Determine, preliminarily, the activity of this treatment regimen in these patients.

- Assess the pharmacokinetics of this treatment regimen in these patients.

OUTLINE: This is a dose-escalation study of fludarabine.

Patients receive UCN-01 IV over 72 hours on days 1-3 alone during course 1 and over 36 hours
on days 1-2 during courses 2-7. Patients also receive fludarabine IV over 30 minutes
beginning on day 1 and continuing for up to 5 days during courses 2-7. Courses repeat every
28 days in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of fludarabine 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 every 2 months for 6 months, every 3 months for 1 year, and then every
6 months thereafter.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

Inclusion Criteria


- 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



- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 50,000/mm^3

- No active Coomb's-positive hemolytic anemia


- Total bilirubin less than 2.0 mg/dL (unless elevation is due to Gilbert's disease and
direct bilirubin is normal)


- Creatinine less than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min


- No angina

- No congestive heart failure

- No myocardial infarction within the past 6 months


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No insulin-dependent diabetes mellitus


Biologic therapy:

- Not specified


- 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


- Not specified


- Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Wyndham H. Wilson, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

July 1999

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • 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
  • Leukemia
  • Lymphoma



Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182
NCI - Center for Cancer Research Bethesda, Maryland  20892