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| Sponsors and Collaborators: |
Vion Pharmaceuticals National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00070538 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining VNP40101M with cytarabine in treating patients who have hematologic malignancies, including myelodysplastic syndrome or relapsed, refractory, or untreated leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Drug: cytarabine Drug: laromustine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase I Study Of VNP40101M And Cytarabine For Patients With Hematologic Malignancies |
| Study Start Date: | June 2003 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation study of VNP40101M.
Patients receive cytarabine IV over 24 hours on days 1-4 for patients under 65 years of age OR on days 1-3 for patients 65 years of age and over. Patients also receive VNP40101M IV over 15-60 minutes on day 2. Treatment repeats every 4 weeks for up to 3 courses (in patients with responding disease) in the absence of disease progression or unacceptable toxicity. Patients with a continued response may receive additional courses at the discretion of the investigator.
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 patients may receive treatment at the MTD.
PROJECTED ACCRUAL: Approximately 25 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:
Diagnosis of leukemia or myelodysplastic syndromes (MDS) meeting criteria for 1 of the following:
Relapsed or refractory leukemia for which there is no standard therapy anticipated to result in a durable remission
Chronic myelogenous leukemia
Any of the following poor-risk MDS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No uncontrolled active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4095 | |
| Study Chair: | Mario Sznol, MD | Vion Pharmaceuticals |
More Information
| Study ID Numbers: | CDR0000334879, VION-CLI-034, MDA-2003-0326 |
| Study First Received: | October 3, 2003 |
| Last Updated: | December 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00070538 |
| Health Authority: | United States: Federal Government |
|
recurrent adult acute lymphoblastic leukemia blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia chronic myelomonocytic leukemia refractory anemia with excess blasts in transformation refractory anemia with excess blasts recurrent adult acute myeloid leukemia untreated adult acute myeloid leukemia untreated adult acute lymphoblastic leukemia |
de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) |
|
Blast Crisis Leukemia, Lymphoid Hematologic Neoplasms Precancerous Conditions Chronic myelogenous leukemia Chronic myelomonocytic leukemia Refractory anemia Leukemia, Myeloid, Acute Acute lymphoblastic leukemia, adult Leukemia Preleukemia Anemia, Refractory Neoplasm Metastasis Acute myeloid leukemia, adult Congenital Abnormalities |
Acute myelocytic leukemia Cytarabine Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myelodysplasia Acute myelogenous leukemia Anemia Leukemia, Myeloid Recurrence Leukemia, Myelogenous, Chronic, BCR-ABL Positive Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases |
|
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Disease Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Pathologic Processes Neoplasms by Site Syndrome Therapeutic Uses |
