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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006760 |
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 |
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Lymphoma |
Biological: filgrastim Drug: ifosfamide Drug: vinorelbine ditartrate |
Phase II |
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 |
Study Start Date: | May 2001 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed refractory or relapsed Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Tanya Trippett, MD | Memorial Sloan-Kettering Cancer Center |
Investigator: | Pedro A. de Alarcon, MD | St. Jude Children's Research Hospital |
Study ID Numbers: | CDR0000068325, COG-AHOD00P1, CCG-A5981 |
Study First Received: | December 6, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00006760 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Immunoproliferative Disorders Hodgkin Lymphoma, Childhood Hodgkin Lymphoma, Adult Hodgkin's Disease Vinblastine Sclerosis Antimitotic Agents Recurrence Lymphatic Diseases Ifosfamide |
Vinorelbine Mechlorethamine Tubulin Modulators Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic Alkylating Agents Lymphoma Hodgkin Disease Isophosphamide mustard |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Mitosis Modulators Vinblastine Antimitotic Agents Pharmacologic Actions Lymphatic Diseases Neoplasms |
Ifosfamide Vinorelbine Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic Alkylating Agents Hodgkin Disease Lymphoma Isophosphamide mustard |