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Home > "C" Clinical Trials Conditions > CHS 828 in Treating Patients With Solid Tumors  CHS 828 in Treating Patients With Solid Tumors
CHS 828 in Treating Patients With Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): EORTC New Drug Development Group ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasCerny, Study Chair, Kantonsspital - St. Gallen
Institut Bergonie
Bordeaux, , 33076
France
Institut Gustave Roussy
Villejuif, , F-94805
France
Western General Hospital
Edinburgh, Scotland, EH4 2XU
United Kingdom
Vrije Universiteit Medisch Centrum
Amsterdam, , 1001HV
Netherlands
C.R.C. Beatson Laboratories
Glasgow, Scotland, G61 1BD
United Kingdom
Herlev Hospital - University Hospital of Copenhagen
Copenhagen, , DK-2730
Denmark
Erasmus Medical Center
Rotterdam, , 3075 EA
Netherlands
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Kaiser Franz Josef Hospital
Vienna, , A-1100
Austria
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Inselspital, Bern
BERN, , CH-3010
Switzerland
Institut Jules Bordet
Brussels, , B-1000
Belgium
Ludwig Institute for Cancer Research
Brussels, , B-1200
Belgium
Universitaetsklinik und Strahlenklinik - Essen
ESSEN, , D-45122
Germany
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
United Kingdom
Innsbruck Universitaetsklinik
Innsbruck, , A-6020
Austria
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Academisch Ziekenhuis Groningen
Groningen, , 9700 RB
Netherlands
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Kantonsspital - St. Gallen
St. Gallen, , CH-9007
Switzerland
Centre Leon Berard
Lyon, , 69373
France
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Institut Claudius Regaud
Toulouse, , 31052
France
University Hospital
Basel, , CH-4031
Switzerland
Klinikum Nuernberg - Klinikum Nord
Nuremberg, , 90340
Germany
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Additional Information:
Study ID Numbers: CDR0000067183; EORTC-16985
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003979
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
2. Tirapazamine, Carboplatin, and Paclitaxel in Treating Patients With Advanced Malignant Solid Tumors
3. SU5416 and Paclitaxel in Treating Patients With Advanced Cancer
4. Phenoxodiol in Treating Patients With Refractory Solid Tumors
5. Paclitaxel, Folic Acid, and Lometrexol in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Clinical Trials
Other Nuremberg Clinical Trials
CHS 828 in Treating Patients With Solid Tumors
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