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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed under 18 NCI CCG-142A

Objectives

I.  Reinduce a prolonged second hematological remission and increase survival 
in those patients who develop M-3 marrow relapse while on Maintenance therapy 
in CCG-101 or CCG-143.
II.  Evaluate a Phase III pilot study of a combination chemotherapy regimen 
consisting of L-asparaginase, prednisone, vincristine, cytosine arabinoside 
and adriamycin ("LAPOCA") to determine its toxicities and the tolerance of 
such a regimen, as well as its capacity for reinduction of hematological 
remission in children with ALL/AUL in bone marrow relapse.
III.  Evaluate the remission prolongation potential of a second course of 
"prophylactic" central nervous system (CNS) therapy with intrathecal 
methotrexate with or without citrovorum factor rescue.
IV.  Evaluate the effectiveness of dibromodulcitol in prolonging central 
nervous system remission with that of a second course of "prophylactic" CNS 
therapy.
V.  Evaluate the hematological remission Maintenance duration of two systemic 
triple-drug regimens combining cytosine arabinoside plus adriamycin with 
dibromodulcitol or cyclophosphamide.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with acute lymphocytic or 
undifferentiated leukemia with M-3 bone marrow relapse in the Maintenance 
phases of CCG-101 or CCG-143 without previous or current CNS disease.

Expected Enrollment

Protocol closed 02/78.

Outline

Randomized study.
Reinduction:
Nonrandomized treatment.  Enter all patients with M-3 bone marrow relapse and 
no previous or concomitant CNS disease.
Arm I:  5-Drug Combination Chemotherapy, LAPOCA.  L-Asparaginase, L-ASP, 
NSC-10929 or NSC-106977; Prednisone, PRED, NSC-10023; Vincristine, VCR, 
NSC-67574; Cytosine arabinoside, ARA-C, NSC-63878; Adriamycin, ADR, NSC-123127.
CNS Intensification:  Randomized treatment.  Randomize only those M-1 
responders in Arm I who have received only 1 prior course of CNS prophylactic 
therapy while on Protocol CCG-101 or CCG-143.
Arm II:  Methotrexate, MTX, NSC-740; Vincristine, VCR, NSC-67574; Citrovorum 
factor, CF, NSC-3590 (optional).
Arm III:  No CNS Intensification.
Maintenance:  Randomized treatment.  Randomize all M-1 responders in Arm I who 
have received 2 prior courses of CNS prophylactic therapy and those who have 
received 1 prior course of CNS prophylactic therapy but no CNS intensification 
on this protocol (Arm III) to Arm IV or Arm V.  Randomize patients entered to 
CNS therapy (Arm II) to Arm VI or Arm VII upon completion of Intensification 
course.
Arm IV:  3-Drug Combination Chemotherapy.  Dibromodulcitol, DBD, NSC-104800; 
ARA-C; ADR.
Arm V:  3-Drug Combination Chemotherapy.  Cyclophosphamide, CTX, NSC-26271; 
ARA-C; ADR.
Arm VI:  3-Drug Combination Chemotherapy.  DBD, ARA-C, ADR.
Arm VII:  3-Drug Combination Chemotherapy.  CTX, ARA-C, ADR.

Nachman J, Sather HN, Buckley JD, et al.: Young adults 16-21 years of age at diagnosis entered on Childrens Cancer Group acute lymphoblastic leukemia and acute myeloblastic leukemia protocols. Results of treatment. Cancer 71 (10 Suppl): 3377-85, 1993.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Children's Cancer Group

G. Denman Hammond, MD, Protocol chair(Contact information may not be current)		Ph: 316-268-5000