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A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease

Phase 2
30 Years
Not Enrolling

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Trial Information

A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease


- 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

- 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.

Inclusion Criteria


- 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

- Not enrolled on POG-9426 unless there is an extranodal site of recurrence



- 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


- See Disease Characteristics

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 75,000/mm^3 (transfusion independent)


- Bilirubin no greater than 1.5 times normal

- SGOT or SGPT less than 2.5 times normal


- Creatinine no greater than 1.5 times normal

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min


- Shortening fraction at least 27% by echocardiogram OR

- Ejection fraction at least 50% by gated radionuclide


- No other concurrent serious illness

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


Biologic therapy:

- No concurrent immunomodulating agents


- 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)


- Recovered from prior radiotherapy


- Not specified

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cardiac, hepatic, or renal toxicity

Outcome Time Frame:

Up to 1 month after completion of study treatment

Safety Issue:


Principal Investigator

Tanya Trippett, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2001

Completion Date:

March 2012

Related Keywords:

  • Lymphoma
  • 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
  • Hodgkin Disease
  • Lymphoma



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