Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp online chat

	NCI Highlights


	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

Phase III Reinduction with ARA-C/DNM vs CYC/DNM and Maintenance with ARA-C/CTX vs CYC/CTX for Acute Nonlymphocytic Leukemia

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Completed under 20 NCI CCG-243

Objectives

I.  Determine remission reinduction rate using daunomycin combined with either 
cytosine arabinoside or cyclocytidine in patients with acute nonlymphocytic 
leukemia relapsing on previous maintenance regimen of Protocol CCG-241 or 
CCG-102.
II.  Compare duration of bone marrow remission using this combination of 
agents.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with acute myelogenous, 
myelomonocytic, erythro- or monocytic-histiocytic leukemia who have relapsed 
on CCG-241 or CCG-102 Maintenance.  Patients must be less than 20 years of 
age, have an M3 marrow, and be at least 2 weeks past previous chemotherapy in 
the absence of progressive disease.

Expected Enrollment

137 patients have been entered as of June 1982.  Protocol closed August 1982 
and terminated January 1984.

Outline

Randomized study.
Induction:
Arm I:  2-Drug Combination Chemotherapy.  DA:  Cytosine arabinoside, ARA-C, 
NSC-63878; Daunomycin, DNM, NSC-82151.
Arm II:  2-Drug Combination Chemotherapy.  DNM; Cyclocytidine, CYC, NSC-145668.
Maintenance:  Enter M1 responders from Arm I to Arm III, from Arm II to Arm IV.
Arm III:  2-Drug Combination Chemotherapy.  ARA-C; Cyclophosphamide, CTX, 
NSC-26271.
Arm IV:  2-Drug Combination Chemotherapy.  CYC; CTX.
Revised Maintenance (Addenda 1, November 1978, and 2, January 1979).
Arm V:  Sequential 2-Drug Combination Chemotherapies.  VP-16, NSC-141540; plus 
CCNU, NSC-79037; or Cyclophosphamide, CTX, NSC-26271; or Cytosine arabinoside, 
ARA-C, NSC-63878.  (ARA-C replaced by CYC, Addendum 3, November 1979.)

Published Results

Movassaghi N, Higgins G, Pyesmany A, et al.: Evaluation of cyclocytidine in reinduction and maintenance therapy of children with acute nonlymphocytic leukemia previously treated with cytosine arabinoside: a report from Children's Cancer Study Group. Med Pediatr Oncol 12 (5): 352-6, 1984.[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

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.