Cloretazine (VNP40101M) With Hematopoietic Cell Transplantation for Hematologic Malignancies
Completed · Phase 1
Conditions studied: Hematologic Malignancies
In brief
Primary: Define the maximal tolerated dose (MTD) of VNP40401M when given with hematopoietic cell transplantation (HCT) Secondary: * Describe the change in pharmacokinetic (PK) parameters with increasing doses of drug. * Describe and estimate the frequency of \> Grade 3 non-hematologic/non-infectious toxicities at the MTD. * Report the efficacy of the regimen. * Evaluate the rate of engraftment for the regimen.
Key facts
- Study ID
- NCT00521859
- Run by
- M.D. Anderson Cancer Center
- People needed
- 5
- Starts
- 2007-08-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2012-07-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 to 65 years for autotransplant patients and age 18 to 60 years for allotransplant patients.
- Patients with acute leukemia/MDS or lymphoid malignancies, including Hodgkin's and non-Hodgkin's lymphoma (primary refractory or refractory relapse), or multiple myeloma (beyond first remission or unresponsive to therapy), not qualifying for treatment protocols of higher priority.
- Adequate renal function, as defined by serum creatinine <1.5 mg/dL.
- Adequate hepatic function, as defined by SGPT <3 X upper limit of normal; serum bilirubin and alkaline phosphatase <2 X upper limit of normal, or considered not attributable to liver disease in the case of alkaline phosphatase.
- Adequate pulmonary function with FEV1, FVC and DLCO >50% of expected corrected for hemoglobin.
- Adequate cardiac function with left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Zubrod performance status <2
- Patients receiving an allogeneic transplant must have a related or unrelated donor which meets departmental standards for donor selection.
You may not qualify if…
- Uncontrolled life-threatening infections
- HIV positive
- A positive Beta HCG in a woman with child bearing potential as defined as not being post-menopausal for 12 or more months or no previous surgical sterilization procedures.
- Any CNS involvement which has not been controlled for at least 4 weeks
- Patients must be at least 21 days from prior systemic therapy for their malignancy, or have improvement of all reversible toxicities to </= grade 2, whichever occurs first.
- Any patient receiving Antabuse
- Patients should be off metronidazole (Flagyl) for at least 24 hours prior to starting VNP40401M
Where it is running
- UT MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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