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| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004114 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Myelodysplastic Syndromes |
Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Non-Myeloablative Chemotherapy Followed by Unrelated Allogeneic Stem Cell Transplantation in Patients With Advanced Hematologic Malignancies: A Pilot Study |
| Study Start Date: | January 2000 |
OBJECTIVES: I. Determine the feasibility of allogeneic engraftment after unrelated matched allogeneic peripheral blood stem cell transplantation preceded by a nonmyeloablative, fludarabine based conditioning regimen in patients with advanced hematologic malignancies. II. Determine the toxicities of this regimen, especially graft versus host disease, in these patients.
OUTLINE: Patients receive fludarabine IV over 30-60 minutes on days -7 to -4, cyclophosphamide IV over 30 minutes on days -7 to -5, and cytarabine IV over 2 hours on days -4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Filgrastim (G-CSF) is administered IV over 1 hour or subcutaneously beginning on day 1 and continuing until blood counts recover. Patients are followed weekly until day 60 and then monthly for 10 months.
PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven advanced hematologic malignancy unsuitable for standard allogeneic bone marrow transplantation One of the following types: Refractory or relapsed acute myelogenous or lymphocytic leukemia Over 55 years Chronic myelogenous leukemia and failed interferon treatment Over 55 years Lymphoma, chronic lymphocytic leukemia, Hodgkin's disease, or multiple myeloma: Refractory OR More than 2 relapses OR Relapse after autologous peripheral blood stem cell transplantation Myelodysplastic syndrome other than refractory anemia Severe aplastic anemia Under 55 years and either organ dysfunction or not eligible for standard allogeneic bone marrow transplant due to one or more of the following: Chronic hepatitis LVEF less than 50% Karnofsky less than 70% Unrelated matched donor available
PATIENT CHARACTERISTICS: Age: See Disease Characteristics Adult Performance status: See Disease Characteristics Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics SGOT/SGPT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: See Disease Characteristics Pulmonary: DLCO at least 50% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Study Chair: | Christos E. Emmanouilides, MD | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000067340, UCLA-9902026, NCI-G99-1603 |
| Study First Received: | December 10, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004114 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia chronic myelomonocytic leukemia 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 adult T-cell leukemia/lymphoma previously treated myelodysplastic syndromes AIDS-related peripheral/systemic lymphoma recurrent mantle cell lymphoma anaplastic large cell lymphoma refractory cytopenia with multilineage dysplasia recurrent mycosis fungoides/Sezary syndrome 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 |
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Antimetabolites Anti-Infective Agents Vidarabine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Precancerous Conditions Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Preleukemia Pathologic Processes Therapeutic Uses Syndrome |
Alkylating Agents Lymphoma Cytarabine Immunoproliferative Disorders Neoplasms by Histologic Type Disease Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms |
