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CHS 828 in Treating Patients With Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00003979   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 17, 2009   History of Changes

November 1, 1999
February 17, 2009
April 1999
 
 
 
Complete list of historical versions of study NCT00003979 on ClinicalTrials.gov Archive Site
 
 
 
CHS 828 in Treating Patients With Solid Tumors
Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks

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

PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors.

OBJECTIVES:

  • Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.
  • Determine a safe dose of this regimen for phase II evaluation.
  • Determine the pharmacokinetic profile of this regimen in these patients.
  • Determine any antitumor activity in these patients.

OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed for up to 4 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: CHS 828
 
Ravaud A, Cerny T, Terret C, Wanders J, Bui BN, Hess D, Droz JP, Fumoleau P, Twelves C. Phase I study and pharmacokinetic of CHS-828, a guanidino-containing compound, administered orally as a single dose every 3 weeks in solid tumours: an ECSG/EORTC study. Eur J Cancer. 2005 Mar;41(5):702-7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
30
 
 

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor not amenable to standard therapy
  • No symptomatic brain or leptomeningeal involvement

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • Other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases)

Renal:

  • Creatinine no greater than 1.4 mg/dL

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active bacterial infection
  • No other nonmalignant disease
  • No alcoholism, drug addiction, or psychiatric disorders
  • Able to take oral medication

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy (6 weeks since extensive radiotherapy)
  • No concurrent radiotherapy (except palliative radiotherapy)

Surgery:

  • Not specified

Other:

  • No other concurrent investigational drugs
  • No other concurrent antitumor drugs
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   France,   Germany,   Netherlands,   Norway,   Switzerland,   United Kingdom
 
NCT00003979
 
CDR0000067183, EORTC-16985
European Organization for Research and Treatment of Cancer
 
Study Chair: Thomas Cerny, MD Kantonsspital - St. Gallen
National Cancer Institute (NCI)
May 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP