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

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ClinicalTrials.gov Identifier: NCT00006760
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 26, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date  ICMJE December 6, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date July 26, 2013
Study Start Date  ICMJE May 2001
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2013)
Overall response rate [ Time Frame: After 2 cycles ]
Overall response includes complete response (CR) or partial response (PR).
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00006760 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2013)
  • Rate of successful PBSC harvest during re-induction defined as the ability to harvest 5 x 10^6 CD34+ cells/kg [ Time Frame: After 2 cycles ]
    Will be calculated.
  • Biologic markers [ Time Frame: At enrollment and during/after therapy ]
  • Cardiac, hepatic, renal, hematologic toxicity [ Time Frame: Within 1 month of completion of therapy ]
  • Toxic death [ Time Frame: Within 1 month of Completion of therapy ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma
Official Title  ICMJE A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Biological: filgrastim
    subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover.
  • Drug: ifosfamide
    V over 24 hours on days 1-4
  • Drug: vinorelbine tartrate
    IV over 6-10 minutes on days 1 and 5.
Study Arms  ICMJE Experimental: Treatment (ifosfamide, vinorelbine, filgrastim)
Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine tartrate 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.
Interventions:
  • Biological: filgrastim
  • Drug: ifosfamide
  • Drug: vinorelbine tartrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2013)
66
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries Netherlands,   New Zealand,   Puerto Rico,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT00006760
Other Study ID Numbers  ICMJE AHOD00P1
CCG-A5981 ( Other Identifier: Children's Cancer Group )
CDR0000068325 ( Other Identifier: Clinical Trials.gov )
NCI-2012-02366 ( Other Identifier: NCI )
U10CA098543 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Oncology Group
Study Sponsor  ICMJE Children's Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Tanya Trippett, MD Memorial Sloan Kettering Cancer Center
Study Chair: Pedro A. de Alarcon, MD St. Jude Children's Research Hospital
PRS Account Children's Oncology Group
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP