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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	under 22	NCI	CCG-201

Objectives

I.  Assess the therapeutic efficacy of m-AMSA/cyclocytidine (m-AMSA/cytosine 
arabinoside, per Addendum 2, February 1985) as reinduction chemotherapy for 
children with ANLL in bone marrow relapse.
II.  Evaluate m-AMSA/VP-16213 as maintenance therapy for children with ANLL in 
second or subsequent remission.
III.  Evaluate the toxic effects of m-AMSA combined with either cyclocytidine 
(cytosine arabinoside, per Addendum 2) or VP-16213 in children with ANLL, 
especially those with prior anthracycline therapy, and seek means of reducing 
this toxicity.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients not over the age of 21 years 
with previously treated ANLL who did not achieve remission with (or relapsed 
on) CCG-251 or who are in relapse from other protocols.  Patients must be off 
all chemotherapy for at least 2 weeks in the absence of progressive disease 
and/or shall have recovered from the toxicity of previous chemotherapy.  The 
life expectancy should be at least 4 weeks.  There must be adequate renal, 
hepatic, GI, and cardiac function.

Expected Enrollment

24-36 patients are expected to be accrued over 12-18 months.

Outline

Nonrandomized study.  Patients with extramedullary disease enter the 
appropriate treatment regimens upon diagnosis.
Induction:  2-Drug Combination Chemotherapy.  m-AMSA, AMSA, NSC-249992; 
Cyclocytidine, CYC, NSC-145668.  Per Addendum 2, Cyclocytidine has been 
replaced with Cytosine arabinoside, ARA-C, NSC-63878.
Maintenance:  2-Drug Combination Chemotherapy.  AMSA; VP-16213, VP-16, 
NSC-141540.
CNS Therapy:  Single-agent Intrathecal Chemotherapy.  Methotrexate, MTX, 
NSC-740; or Cytosine arabinoside, ARA-C, NSC-63878.
Testicular Leukemia Therapy:  Radiotherapy.  Irradiation of both testes; 
details of equipment not given.

Trial Contact Information

Trial Lead Organizations

Children's Cancer Group

Allan Pyesmany, MD, Protocol chair(Contact information may not be current)		Ph: 902-470-8888 Email: allen.pyesmany@lwk.nshealth.ca