ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2007

Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028522
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of XK469 in treating patients with advanced solid tumors or lymphoma.


Condition Intervention Phase
Lymphoma
Neuroblastoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: R(+)XK469
Phase I

MedlinePlus related topics:   Cancer    Fungal Infections    Hodgkin's Disease    Intestinal Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Neuroblastoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Study Of R(+)XK469 In Patients With Advanced Solid Tumors And Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   85
Study Start Date:   November 2001
Estimated Primary Completion Date:   December 2004 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose, recommended phase II dose, and dose-limiting toxicity of R(+)XK469 in two different dosing schedules in patients with advanced solid tumors or lymphomas.
  • Determine the safety of this drug in these patients.
  • Determine the tolerance to this drug in these patients.
  • Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
  • Determine, preliminarily, any antineoplastic activity of this drug in these patients.

OUTLINE: This is a dose-escalation study.

  • Schedule A: Patients receive R(+)XK469 IV over 30 minutes on days 1, 3, and 5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of R(+)XK469 until the recommended phase II dose or maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the recommended phase II dose (for a maximum of 20 patients treated at that dose).

  • Schedule B: Once the recommended phase II dose is determined on schedule A, additional patients are accrued and receive escalating doses of R(+)XK469 IV over 30-60 minutes on day 1, beginning at a reduced dose. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Dose escalation continues as in schedule A.

PROJECTED ACCRUAL: Approximately 85 patients will be accrued for this study within 2.5-3.5 years.

  Eligibility
Ages Eligible for Study:   5 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed neuroblastoma that is refractory to standard therapy or for which no standard therapy exists
  • No active brain metastases

    • Previously treated brain metastases allowed if there is no requirement for corticosteroids or anticonvulsants

PATIENT CHARACTERISTICS:

Age:

  • 5 to 20 years old

Performance status:

  • Karnofsky performance status 70-100% or Lansky score ≥ 70 for your pediatric patients

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal (unless due to documented Gilbert's syndrome)

Renal:

  • Creatinine less than 1.5 times upper limit of normal

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other concurrent uncontrolled illness that would preclude study participation
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study participation
  • No prior allergic reaction to compounds of similar chemical or biological composition to study drug (e.g., flurbiprofen or ibuprofen)
  • No HIV-positive patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic agents

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • No other concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent palliative radiotherapy

Surgery:

  • Not specified

Other:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • No other concurrent investigational agents
  • No concurrent commercial agents or therapies directed at malignancy
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028522

Locations
United States, Illinois
University of Chicago Cancer Research Center     Recruiting
      Chicago, Illinois, United States, 60637-1470
      Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        

Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)

Investigators
Study Chair:     Samir D. Undevia, MD     University of Chicago    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000069101, UCCRC-11108B, NCI-4570
First Received:   January 4, 2002
Last Updated:   October 1, 2008
ClinicalTrials.gov Identifier:   NCT00028522
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma  
stage IV adult Hodgkin lymphoma  
recurrent adult Hodgkin lymphoma  
stage III cutaneous T-cell non-Hodgkin lymphoma  
stage IV cutaneous T-cell non-Hodgkin lymphoma  
recurrent cutaneous T-cell non-Hodgkin lymphoma  
small intestine lymphoma  
unspecified adult solid tumor, protocol specific  
stage III grade 1 follicular lymphoma  
stage III grade 2 follicular lymphoma  
stage III grade 3 follicular lymphoma  
stage III adult diffuse small cleaved cell lymphoma  
stage III adult diffuse mixed cell lymphoma  
stage III adult diffuse large cell lymphoma  
stage III adult immunoblastic large cell lymphoma  
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma

Study placed in the following topic categories:
Sezary syndrome
Neuroectodermal Tumors, Primitive
Lymphoma, Mantle-Cell
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Duodenal Neoplasms
Mycoses
Lymphoma, Large-Cell, Anaplastic
Neuroepithelioma
Hodgkin Disease
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Leukemia, B-cell, chronic
Neuroectodermal Tumors
B-cell lymphomas
Leukemia, T-Cell
Gastrointestinal Neoplasms
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Neoplasms, Glandular and Epithelial
Hodgkin's disease
Gastrointestinal Diseases
Cutaneous T-cell lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Sezary Syndrome

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immune System Diseases
Jejunal Diseases
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Ileal Diseases

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers