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| Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005998 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation using specially treated stem cells may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation using specially treated stem cells in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: etoposide Drug: filgrastim Drug: mitoxantrone hydrochloride Drug: retrovirus vector LN Procedure: in vitro-treated peripheral blood stem cell transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Autologous Transplantation for Non-Hodgkin's Lymphoma and Hodgkin's Disease Using Retrovirally Marked Peripheral Blood Progenitor Cells Obtained After In Vivo Mobilization Using Hematopoietic Cytokines Plus Chemotherapy |
| Study Completion Date: | March 2003 |
OBJECTIVES:
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) twice daily on days 1-7. Peripheral blood stem cells (PBSC) are collected on days 5-7.
Patients receive cyclophosphamide IV over 2 hours, mitoxantrone IV, and cytarabine IV every 12 hours for 2 doses on day 10, and dexamethasone every 12 hours for 4 doses on days 10 and 11. Patients receive G-CSF SC for the next 10-20 days. Additional PBSC are collected on days 25-28 or 29. Beginning 7 days before PBSC transplantation, patients receive cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation (TBI) twice daily on days -4 to -1. Patients unable to tolerate TBI receive cyclophosphamide IV over 2 hours on days -6 to -3, carmustine IV over 1 hour on days -6, and etoposide IV over 1 hour every 12 hours on days -6 to -4. Retrovirally transduced PBSC are reinfused on day 0 followed by another course of G-CSF SC until hematopoietic recovery.
Patients are followed at 1, 3, 6, 9, 12, 18, and 24 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 12-15 months.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Intermediate or high grade non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD)
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations More Information
| Study ID Numbers: | CDR0000068002, UMN-MT-1999-19, NCI-G00-1807 |
| Study First Received: | July 5, 2000 |
| Last Updated: | December 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005998 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
|
Anti-Inflammatory Agents Dexamethasone Lymphoma, Mantle-Cell Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Mantle Cell Lymphoma Follicular Lymphoma Hormones Leukemia, Lymphocytic, Chronic, B-Cell Hodgkin Disease Etoposide Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antineoplastic Agents, Hormonal |
Carmustine Glucocorticoids B-cell Lymphomas Mitoxantrone Lymphoma, Non-Hodgkin Antimetabolites Immunologic Factors Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Cyclophosphamide Lymphoblastic Lymphoma Etoposide phosphate Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell |
|
Anti-Inflammatory Agents Antimetabolites Dexamethasone Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Cyclophosphamide Hormones Sensory System Agents Therapeutic Uses |
Analgesics Lymphoma Hodgkin Disease Alkylating Agents Cytarabine Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Carmustine Gastrointestinal Agents Glucocorticoids Antiviral Agents Immunosuppressive Agents Pharmacologic Actions |
