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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005967 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Randomized phase I trial to study the effectiveness of tipifarnib in treating patients who have advanced hematologic cancer.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Drug: tipifarnib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Dose Finding Study of R115777 (NSC 702818) in Patients With Advanced Hematologic Malignancies |
Study Start Date: | August 2000 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 dose levels.
Patients receive oral tipifarnib twice daily for 21 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 1 course of therapy, patients may receive subsequent therapy at the maximum tolerated dose at the investigator's discretion.
PROJECTED ACCRUAL: A total of 32-36 patients will be accrued for this study within 16 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed hematologic malignancy refractory to standard therapy or for which no known effective therapy exists
Hodgkin's or non-Hodgkin's lymphoma
Chronic myelogenous leukemia
Chronic phase
Accelerated phase
Blastic phase
Myelodysplastic syndromes
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 |
Study Chair: | Todd M. Zimmerman, MD | University of Chicago |
Study ID Numbers: | CDR0000067950, UCCRC-10294, NCI-42 |
Study First Received: | July 5, 2000 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00005967 History of Changes |
Health Authority: | United States: Federal Government |
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma refractory multiple myeloma stage III multiple myeloma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia refractory anemia with excess blasts |
refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma |
Polycythemia Chronic Myelomonocytic Leukemia Blast Crisis Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Refractory Anemia Acute Myelocytic Leukemia Preleukemia Anemia, Refractory Hemorrhagic Disorders Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Thrombocythemia, Hemorrhagic |
Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma B-cell Lymphomas Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Leukemia, Lymphoid |
Precancerous Conditions Antineoplastic Agents Blood Protein Disorders Paraproteinemias Hemostatic Disorders Leukemia Preleukemia Pathologic Processes Hemorrhagic Disorders Therapeutic Uses Syndrome Cardiovascular Diseases Lymphoma Tipifarnib Neoplasms by Histologic Type |
Immunoproliferative Disorders Disease Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Vascular Diseases Pharmacologic Actions Multiple Myeloma Lymphatic Diseases Neoplasms Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Bone Marrow Diseases Neoplasms, Plasma Cell |