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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00095797 |
RATIONALE: Drugs used in chemotherapy, such XK469R, work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of XK469R in treating patients who have refractory hematologic cancer.
Condition | Intervention | Phase |
---|---|---|
Leukemia Myelodysplastic Syndromes |
Drug: R(+)XK469 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study of XK469R (NSC 698215) in Patients With Refractory Hematologic Malignancies |
Estimated Enrollment: | 60 |
Study Start Date: | October 2004 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive XK469R IV over 30-60 minutes on days 1, 3, and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of XK469R until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity. A total of 12 patients receive treatment at the MTD.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following relapsed or refractory hematologic malignancies for which all potentially curative therapy options have been exhausted:
Myelodysplastic syndromes*, including the following:
Chronic lymphocytic leukemia
Failed prior fludarabine-based therapy and ≥ 1 other therapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
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 | |
United States, Texas | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4095 |
Principal Investigator: | Francis J. Giles, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000393836, MDA-2004-0154, NCI-6939 |
Study First Received: | November 9, 2004 |
Last Updated: | January 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00095797 History of Changes |
Health Authority: | United States: Federal Government |
adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia untreated adult acute myeloid leukemia blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia recurrent adult acute lymphoblastic leukemia chronic myelomonocytic leukemia refractory anemia with excess blasts in transformation refractory anemia with excess blasts adult acute basophilic leukemia adult acute eosinophilic leukemia de novo myelodysplastic syndromes |
previously treated myelodysplastic syndromes secondary myelodysplastic syndromes refractory chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) |
Leukemia, Monocytic, Acute Chronic Myelomonocytic Leukemia Blast Crisis Leukemia, Lymphoid Hematologic Neoplasms Precancerous Conditions Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Refractory Anemia Leukemia Acute Erythroblastic Leukemia Acute Myelocytic Leukemia Preleukemia Anemia, Refractory |
Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Leukemia, B-cell, Chronic Congenital Abnormalities Acute Lymphoblastic Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Anemia Leukemia, Myeloid Recurrence Leukemia, Myelomonocytic, Acute Chronic Lymphocytic Leukemia |
Leukemia Neoplasms Preleukemia Pathologic Processes Disease Neoplasms by Histologic Type |
Precancerous Conditions Hematologic Diseases Syndrome Myelodysplastic Syndromes Bone Marrow Diseases |