VNP40101M in Treating Patients With Richter Syndrome or Refractory or Relapsed Chronic Lymphocytic Leukemia or Other Lymphoproliferative Disorders

NCT00304005 | Completed Phase 1

• 3 other identifiers: VION-CLI-041CDR0000465217MDA-2005-0249
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M and to see how well it works in treating patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disorders.

Conditions

Leukemia; Lymphoma

Keywords

refractory chronic lymphocytic leukemia; recurrent adult diffuse large cell lymphoma; recurrent adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose

• Toxicity

• Efficacy

Interventions

laromustine DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following hematologic malignancies: * Fludarabine refractory or relapsed chronic lymphocytic leukemia (CLL) * CLL in transformation allowed * Richter syndrome * Other refractory lymphoproliferative diseases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Creatinine ≤ 2.0 mg/dL * Renal dysfunction due to organ infiltration by disease allowed * AST and ALT ≤ 3 times upper limit of normal (ULN) (unless due to organ infiltration by disease) * Bilirubin ≤ 1.5 times ULN (unless due to Gilbert's syndrome) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infection * No symptomatic coronary artery disease * No arrhythmia not controlled by medication * No uncontrolled, symptomatic congestive heart failure * No myocardial infarction within the past 3 months * No other uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior cytotoxic therapy except in patients with rapidly progressing disease * No other concurrent standard or investigational treatment for this cancer * No other concurrent cytotoxic investigational drugs * No concurrent disulfiram

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vion Pharmaceuticals: lead

Study Sites (1)

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Leukemia; Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Large B-Cell, Diffuse; Hodgkin Disease

Interventions

laromustine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Study Officials

• Bonny L. Johnson, RN, MSN

  Vion Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: July 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: August 1, 2008
• Last Updated: July 18, 2013

Record last verified: 2008-08

Locations

US (1)