Proof M. D. Anderson Experiments With Our Kids
This study is currently recruiting patients.Verified by National Cancer Institute (NCI) May 2004
Sponsors and Collaborators:
Children's Oncology Group
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
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.
recurrent/refractory childhood Hodgkin's lymphomachildhood lymphocyte predominant Hodgkin's lymphomachildhood lymphocyte depletion Hodgkin's lymphomachildhood nodular sclerosis Hodgkin's lymphomachildhood mixed cellularity Hodgkin's lymphoma
Drug: filgrastim Drug: ifosfamide Drug: vinorelbine Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: colony-stimulating factor therapy Procedure: cytokine therapy
MedlinePlus related topics: Hodgkin's Disease
Study Type: InterventionalStudy Design: Treatment
Official Title: Phase II Pilot Study of Reinduction Chemotherapy With Ifosfamide and Vinorelbine in Children With Refractory or Relapsed Hodgkin's Lymphoma
Further Study Details:
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. [Katie is receiving a fouth course of therapy! EDWARD]
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.
This may be the trial Katie has been placed in. Even if she is not officially in this trial, these are the exact chemicals they are using on her now. This is a phase II trial --not proven therapy. Like I've said before they are using our kids to experiment on for cancer research and they force them into these trials and than don't modify treatment even at the risk of patient dying because that would mess up the results and they would not get their government money for doing the trial. They don't even notify the parents that these are experimental drugs being used. These are people, not animals, and I don't want my daughter experimented on.