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Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma

This study has been completed.

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006760
  Purpose

RATIONALE: Drugs used in chemotherapy, such as ifosfamide and vinorelbine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have refractory or relapsed Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: filgrastim
Drug: ifosfamide
Drug: vinorelbine ditartrate
Phase II

MedlinePlus related topics:   Cancer    Hodgkin's Disease    Lymphoma   

ChemIDplus related topics:   Ifosfamide    Filgrastim    Vinorelbine    Vinorelbine tartrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Cardiac, hepatic, or renal toxicity [ Designated as safety issue: Yes ]
  • Toxic death [ Designated as safety issue: Yes ]
  • Hematological toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Nonhematological toxicity (grade 3 or 4) [ Designated as safety issue: Yes ]
  • Peripheral blood stem cell harvest [ Designated as safety issue: No ]
  • Response [ Designated as safety issue: No ]
  • Induction success [ Designated as safety issue: No ]

Study Start Date:   May 2001
Primary Completion Date:   February 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Determine the response rate (overall and within strata) in both minimally pretreated, low-risk and heavily pretreated, high-risk children with refractory or relapsed Hodgkin's lymphoma treated with ifosfamide and vinorelbine with filgrastim (G-CSF).
  • Determine the cardiac, hepatic, renal, and hematologic toxicity of this regimen in minimally-pretreated, low-risk patients.
  • Determine the toxic death rate in minimally pretreated, low-risk patients treated with this regimen.
  • Determine whether this treatment regimen can mobilize sufficient hematopoietic stem cells (CD34) for subsequent stem cell transplantation in minimally pretreated, low-risk patients.
  • Determine the incidence of hypermutability by longitudinal genotoxic biomonitoring of patients treated with this regimen.
  • Determine the prognostic significance of biological markers, including serum interleukin (IL)-10 receptor, serum IL-2 receptor, p53, and mdm-2 in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified by prior therapy (minimally pretreated, low-risk vs heavily pretreated, high-risk).

Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator.

Heavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121.

Patients are followed at 1, 6, and 12 months and then periodically thereafter.

PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study within 1.5 years.

  Eligibility
Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed refractory or relapsed Hodgkin's lymphoma

    • Mixed cellularity, not otherwise specified (NOS)
    • Lymphocytic depletion, NOS
    • Lymphocytic depletion, diffuse fibrosis
    • Lymphocytic depletion, reticular
    • Lymphocytic predominance, NOS
    • Lymphocytic predominance, diffuse
    • Lymphocytic predominance, nodular
    • Hodgkin's paragranuloma NOS
    • Hodgkin's granuloma
    • Hodgkin's sarcoma
    • Nodular sclerosis, NOS
    • Nodular sclerosis, cellular phase
    • Nodular sclerosis, lymphocytic predominance
    • Nodular sclerosis, mixed cellularity
    • Nodular sclerosis, lymphocytic depletion
    • Other (type not specified)
  • In first relapse
  • Metastasis to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia allowed
  • Not enrolled on POG-9426 unless there is an extranodal site of recurrence

PATIENT CHARACTERISTICS:

Age:

  • Under 30 at diagnosis

Performance status:

  • Lansky 60-100% (for patients 16 years and under)
  • Karnofsky 60-100% (for patients over 16 years)

Life expectancy:

  • At least 2 months

Hematopoietic:

  • See Disease Characteristics
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3 (transfusion independent)

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT or SGPT less than 2.5 times normal

Renal:

  • Creatinine no greater than 1.5 times normal
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Cardiovascular:

  • Shortening fraction at least 27% by echocardiogram OR
  • Ejection fraction at least 50% by gated radionuclide

Other:

  • No other concurrent serious illness
  • No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or any other component of study drugs

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunomodulating agents

Chemotherapy:

  • At least 2 weeks since prior chemotherapy (3 weeks for nitrosoureas) and recovered
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • No concurrent steroids
  • No concurrent corticosteroids (e.g., dexamethasone)

Radiotherapy:

  • Recovered from prior radiotherapy

Surgery:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006760

Show 114 study locations  Show 114 Study Locations

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Tanya Trippett, MD     Memorial Sloan-Kettering Cancer Center    
Investigator:     Pedro A. de Alarcon, MD     St. Jude Children's Research Hospital    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068325, COG-AHOD00P1, CCG-A5981
First Received:   December 6, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006760
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent/refractory childhood Hodgkin lymphoma  
childhood lymphocyte predominant Hodgkin lymphoma  
childhood lymphocyte depletion Hodgkin lymphoma  
childhood nodular sclerosis Hodgkin lymphoma  
childhood mixed cellularity Hodgkin lymphoma  

Study placed in the following topic categories:
Immunoproliferative Disorders
Hodgkin's disease
Hodgkin lymphoma, adult
Vinblastine
Sclerosis
Recurrence
Lymphatic Diseases
Ifosfamide
Vinorelbine
Mechlorethamine
Hodgkin lymphoma, childhood
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease
Isophosphamide mustard

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 03, 2008




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