Cloretazine (VNP40101M) With Hematopoietic Cell Transplantation for Hematologic Malignancies
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Vion Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00521859
First received: August 27, 2007
Last updated: July 27, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hematologic Malignancies |
Drug: Cloretazine Drug: Fludarabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 5 |
| Study Start Date: | August 2007 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521859
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Vion Pharmaceuticals
Investigators
| Principal Investigator: | Roy B. Jones, MD, PhD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00521859 History of Changes |
| Other Study ID Numbers: | 2005-0844 |
| Study First Received: | August 27, 2007 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Hematologic Malignancies Leukemia Lymphoma Myeloma Hodgkin's Disease Hematopoietic Cell Transplantation Cloretazine |
VNP40101M Fludarabine Fludarabine Phosphate Fludara ATG Antithymocyte Thymoglobulin |
Additional relevant MeSH terms:
|
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases Fludarabine Fludarabine monophosphate Vidarabine Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 22, 2013