Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Aminocamptothecin in Treating Patients With Relapsed B-cell Chronic Lymphocytic Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	JHOC-9537 NCI-T95-0029H, T95-0029

Objectives

I.  Evaluate the efficacy and toxicity of aminocamptothecin (9-AC) 
administered by 72-hour infusion every 2 weeks to patients with relapsed 
B-cell chronic lymphocytic leukemia.

II.  Correlate antitumor activity of 9-AC with laboratory markers of tumor 
resistance.

Entry Criteria

Disease Characteristics:

B-cell chronic lymphocytic leukemia (CLL), i.e.:
  Predominate expression of B-cell antigens, including CD5, in the absence of
     pan-T-cell markers such as CD2 and CD3
  Kappa or lambda light chain expression 
  Low density surface Ig expression

Absolute circulating lymphocytosis at least 5,000
  Lymphocytes morphologically mature
  Up to 55% may be atypical lymphocytes, prolymphocytes, or lymphoblasts

Marrow aspirate and biopsy normocellular or hypercellular
  At least 30% of nucleated cells lymphoid
  Lymphocytic infiltration diffuse or nondiffuse

The following lymphoproliferative disorders are specifically excluded:  
  T-cell CLL
  Prolymphocytic leukemia
  Hairy cell leukemia and variants 
  Splenic lymphoma with villous lymphocytes 
  Large granular lymphocytosis 
  Sezary cell leukemia
  Adult T-cell leukemia/lymphoma
  Leukemic manifestations of non-Hodgkin's lymphomas

Ineligible for or patient declined bone marrow transplantation

Prior/Concurrent Therapy:

Recovered from significant toxicity of prior therapy

Biologic therapy:
  Not specified

Chemotherapy:
  At least 1 but no more than 2 prior regimens required
  No more than 6 cycles of fludarabine over 12 months

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior pelvic radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-2

Life expectancy:
  At least 3 months

Hematopoietic:
  See Disease Characteristics

Hepatic:
  Bilirubin no greater than 2.0 mg/dL
  AST and ALT less than 100 U/liter

Renal:
  Creatinine no greater than 1.5 mg/dL

Other:
  No active infection requiring systemic antibiotics
  No medical condition unrelated to CLL that would preclude protocol
     participation
  No pregnant women
  Effective contraception required of fertile patients

Expected Enrollment

If 1 of the first 12 evaluable patients responds, an additional 25 patients 
will be entered.  An accrual rate of 1-2 patients per month is anticipated.

Outline

Single-Agent Chemotherapy.  Aminocamptothecin, 9-AC, NSC-603071.

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Michael Grever, MD, Protocol chair		Ph: 614-293-8724 Email: michael.greever@osumc.edu