Cloretazine (VNP40101M) With Hematopoietic Cell Transplantation for Hematologic Malignancies

NCT00521859 | Completed Phase 1

• 1 other identifier: 2005-0844
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematologic Malignancies

Keywords

Hematologic Malignancies; Leukemia; Lymphoma; Myeloma; Hodgkin's Disease; Hematopoietic Cell Transplantation; Cloretazine; VNP40101M; Fludarabine; Fludarabine Phosphate; Fludara; ATG; Antithymocyte; Thymoglobulin

Outcome Measures

Primary Outcomes (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.

  2 Years

Study Arms (1)

Cloretazine + Fludarabine

EXPERIMENTAL

Drug: Cloretazine; Drug: Fludarabine

Interventions

Cloretazine DRUG

800 mg/m\^2 by vein daily

Also known as: VNP40101M

Cloretazine + Fludarabine

Fludarabine DRUG

25 mg/m\^2 by vein daily x 5 Days

Also known as: Fludarabine Phosphate, Fludara

Cloretazine + Fludarabine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Vion Pharmaceuticals: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Lymphoma; Neoplasms, Plasma Cell; Hodgkin Disease

Interventions

laromustine; fludarabine; fludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Roy B. Jones, MD, PhD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 28, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

US (1)