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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00381940 |
Purpose
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as ifosfamide and vinorelbine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may help ifosfamide and vinorelbine work better by making cancer cells more sensitive to the drugs. Giving bortezomib together with ifosfamide and vinorelbine may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib together with ifosfamide and vinorelbine works in treating young patients with Hodgkin's lymphoma that is recurrent or did not respond to previous therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: filgrastim Drug: bortezomib Drug: ifosfamide Drug: vinorelbine ditartrate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of Bortezomib (Velcade, PS-341, IND # 58443) in Combination With Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults With Refractory/Recurrent Hodgkin Disease |
| Estimated Enrollment: | 48 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, pilot study.
Patients receive ifosfamide IV continuously over days 1-4, vinorelbine ditartrate IV over 6-10 minutes on days 1 and 5, bortezomib IV on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or peripheral blood stem cells (PBSC) are harvested. Treatment repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.
After completion of study treatment, patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed Hodgkin's lymphoma at time of relapse or disease progression, meeting all of the following criteria:
Meets 1 of the following criteria:
Primary refractory disease OR disease in first relapse, except for the following:
Measurable disease, defined as 1 of the following:
Patients with metastatic disease to bone marrow and granulocytopenia, anemia, and/or thrombocytopenia are allowed provided both of the following criteria are met:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent enzyme inducing anticonvulsants that alter p450 metabolism, including phenytoin, carbamazepine, phenobarbital, or other anticonvulsants
No other concurrent chemotherapy or immunomodulating agents (including steroids)
Contacts and Locations
Show 93 Study Locations| Study Chair: | Terzah M. Horton, MD, PhD | Texas Children's Cancer Center |
| Investigator: | Richard A. Drachtman, MD | Cancer Institute of New Jersey |
More Information
| Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
| Study ID Numbers: | CDR0000500142, COG-AHOD0521 |
| Study First Received: | September 26, 2006 |
| Last Updated: | October 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00381940 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
adult lymphocyte depletion Hodgkin lymphoma adult lymphocyte predominant Hodgkin lymphoma adult mixed cellularity Hodgkin lymphoma adult nodular sclerosis Hodgkin lymphoma childhood lymphocyte depletion Hodgkin lymphoma childhood lymphocyte predominant Hodgkin lymphoma childhood mixed cellularity Hodgkin lymphoma childhood nodular sclerosis Hodgkin lymphoma recurrent adult Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma |
stage I adult Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage II adult Hodgkin lymphoma stage II childhood Hodgkin lymphoma stage III adult Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage IV childhood Hodgkin lymphoma adult nodular lymphocyte predominant Hodgkin lymphoma childhood nodular lymphocyte predominant Hodgkin lymphoma |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Vinblastine Therapeutic Uses Lymphoma Hodgkin Disease Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Bortezomib Mitosis Modulators Enzyme Inhibitors |
Antimitotic Agents Pharmacologic Actions Protease Inhibitors Lymphatic Diseases Ifosfamide Neoplasms Vinorelbine Tubulin Modulators Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic Isophosphamide mustard |