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Clinical Trials (PDQ®)

  • Last Modified: 10/1/1993

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Clinical Trials (PDQ®)

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
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedunder 21NCICCG-5912

Objectives

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.

Entry Criteria

Disease Characteristics:


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


Prior/Concurrent Therapy:


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


Patient Characteristics:


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


Expected Enrollment

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.

Outline

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.

Published Results

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

Nathan Kobrinsky, MD, Protocol chair
Ph: 701-234-7544

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.

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