Phase II Study of Induction with DECAL (DM/VP-16/CDDP/High-Dose ARA-C/L-ASP) Followed by Intensive Maintenance Chemotherapy with IFF/VP-16 Alternating with DECAL in Children with Recurrent Hodgkin's or non-Hodgkin's Lymphoma (Summary Last Modified 10/93)
Basic Trial Information
|Phase II||Treatment||Closed||under 21||NCI||CCG-5912|
I. Evaluate the toxicity of 2 courses of induction chemotherapy with DECAL (dexamethasone/etoposide/cisplatin/high-dose cytarabine/asparaginase) in children with recurrent or primarily unresponsive Hodgkin's or non-Hodgkin's lymphoma. II. Evaluate the response by disease category to 2 courses of DECAL in children with recurrent or primarily unresponsive Hodgkin's lymphoma and lymphoblastic or nonlymphoblastic (undifferentiated and large cell) non-Hodgkin's lymphoma. III. Evaluate the feasibility of treating children with 2 courses of DECAL and radiotherapy to sites of gross residual disease followed by 4 courses of ifosfamide/etoposide alternating with DECAL.
Lymphomas in the following 2 categories: Localized or disseminated lymphoblastic or nonlymphoblastic (diffuse large cell or small noncleaved cell) non-Hodgkin's lymphoma in first or subsequent relapse Localized or disseminated Hodgkin's disease in first relapse following treatment with a chemotherapy-containing regimen or in second or subsequent relapse (regardless of prior therapy) Tissue confirmation of tumor recurrence required Isolated CSF involvement (total cell count greater than 5/cumm with definite malignant lymphoma cells) allowed
Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified
Age: Under 21 Performance status: Not specified Life expectancy: At least 12 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine clearance greater than 60 ml/min/1.73 sqm OR GFR within institutional normal range
It is anticipated that approximately 55 patients will be entered on Induction and approximately 20 patients without marrow involvement at entry will be enrolled on Maintenance over 1-2 years. The study will be suspended if unacceptable toxicity and/or mortality are seen during Induction or Maintenance.
Nonrandomized study. All patients receive Induction; responding patients who are not referred to bone marrow transplant receive Maintenance. Induction: Sequential 5-Drug Combination Chemotherapy, Hematologic Toxicity Attenuation, Radiotherapy, with, in NHL patients, CNS Prophylaxis/Therapy. DECAL: Dexamethasone, DM, NSC-34521; Etoposide, VP-16, NSC-141540; Cisplatin, CDDP, NSC-119875; Cytarabine, ARA-C, NSC-63878; Asparaginase (E. coli), ASP, NSC-109229 (or, in case of allergy to E. coli ASP, Erwinia ASP, NSC-106977); Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629; plus irradiation of all sites of gross residual disease using Co60 or high-energy photons; with, in NHL patients, intrathecal Methotrexate, IT MTX, NSC-740. Maintenance: Sequential 2-Drug Combination Chemotherapy, Urothelial Protection, Hematologic Toxicity Attenuation, alternating with 5-Drug Combination Chemotherapy, Hematologic Toxicity Attenuation, with, in NHL patients, CNS Prophylaxis/Therapy. VP-16; Ifosfamide, IFF, NSC-109724; Mesna, NSC-113891; and G-CSF; alternating with DECAL; G-CSF; with, in NHL patients and patients with CNS disease at diagnosis, IT MTX.
Kobrinsky NL, Sposto R, Shah NR, et al.: Outcomes of treatment of children and adolescents with recurrent non-Hodgkin's lymphoma and Hodgkin's disease with dexamethasone, etoposide, cisplatin, cytarabine, and l-asparaginase, maintenance chemotherapy, and transplantation: Children's Cancer Group Study CCG-5912. J Clin Oncol 19 (9): 2390-6, 2001.[PUBMED Abstract]
Kobrinsky N, Anderson J, Delaat C, et al.: Dexamethasone, etoposide, cisplatin, ARA-C and L-asparaginase (DECAL) for recurrent Hodgkin's disease (HD) and non-Hodgkin's lymphoma (NHL): a preliminary report from the Children's Cancer Group CCG-5912. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1337, 393, 1994.
Trial Contact Information
Trial Lead Organizations
Children's Cancer Group
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.