Cloretazine (VNP40101M) With Hematopoietic Cell Transplantation for Hematologic Malignancies

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Vion Pharmaceuticals
• Treatments: Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

Inclusion Criteria:

1. Age 18 to 65 years for autotransplant patients and age 18 to 60 years for allotransplant patients.

2. 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.

3. Adequate renal function, as defined by serum creatinine <1.5 mg/dL.

4. 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.

5. Adequate pulmonary function with FEV1, FVC and DLCO >50% of expected corrected for hemoglobin.

6. Adequate cardiac function with left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease.

7. Zubrod performance status <2

8. Patients receiving an allogeneic transplant must have a related or unrelated donor which meets departmental standards for donor selection.

Exclusion Criteria:

1. Uncontrolled life-threatening infections

2. HIV positive

3. 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.

4. Any CNS involvement which has not been controlled for at least 4 weeks

5. Patients must be at least 21 days from prior systemic therapy for their malignancy, or have improvement of all reversible toxicities to

6. Any patient receiving Antabuse

7. Patients should be off metronidazole (Flagyl) for at least 24 hours prior to starting VNP40401M