Cloretazine (VNP40101M) With Hematopoietic Cell Transplantation for Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00521859
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : July 31, 2012
Vion Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:


Define the maximal tolerated dose (MTD) of VNP40401M when given with hematopoietic cell transplantation (HCT)


  • 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.

Condition or disease Intervention/treatment Phase
Hematologic Malignancies Drug: Cloretazine Drug: Fludarabine Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Escalation Trial of Cloretazine (VNP40101M) and Hematopoietic Cell Transplantation for Patients With Selected, Poor-Prognosis Hematologic Malignancies
Study Start Date : August 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: Cloretazine + Fludarabine Drug: Cloretazine
800 mg/m^2 by vein daily
Other Name: VNP40101M
Drug: Fludarabine
25 mg/m^2 by vein daily x 5 Days
Other Names:
  • Fludarabine Phosphate
  • Fludara

Primary Outcome Measures :
  1. To study the highest tolerable dose of VNP40101M that can be given to patients with a form of leukemia, MDS, lymphoma, or myeloma in preparation for an autologous stem cell transplant. [ Time Frame: 2 Years ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 </= grade 2, whichever occurs first.
  6. Any patient receiving Antabuse
  7. Patients should be off metronidazole (Flagyl) for at least 24 hours prior to starting VNP40401M

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00521859

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Vion Pharmaceuticals
Principal Investigator: Roy B. Jones, MD, PhD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00521859     History of Changes
Other Study ID Numbers: 2005-0844
First Posted: August 28, 2007    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Hematologic Malignancies
Hodgkin's Disease
Hematopoietic Cell Transplantation
Fludarabine Phosphate

Additional relevant MeSH terms:
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents