CHS 828 in Treating Patients With Solid Tumors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00003979
• Other study ID #: EORTC-16985
• Secondary ID: EORTC-16985
• Status: Withdrawn
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: July 10, 2012
• Start date: April 1999

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• CHS 828

Locations

Country	Name	City	State
Austria	Innsbruck Universitaetsklinik	Innsbruck
Austria	Kaiser Franz Josef Hospital	Vienna
Belgium	Institut Jules Bordet	Brussels
Belgium	Ludwig Institute for Cancer Research	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Gasthuisberg	Leuven
Denmark	Herlev Hospital - University Hospital of Copenhagen	Copenhagen
France	Institut Bergonie	Bordeaux
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Leon Berard	Lyon
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Institut Claudius Regaud	Toulouse
France	Institut Gustave Roussy	Villejuif
Germany	Universitaetsklinik und Strahlenklinik - Essen	Essen
Germany	Klinikum Nuernberg - Klinikum Nord	Nuremberg
Netherlands	Antoni van Leeuwenhoekhuis	Amsterdam
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Erasmus Medical Center	Rotterdam
Norway	Norwegian Radium Hospital	Oslo
Switzerland	University Hospital	Basel
Switzerland	Inselspital, Bern	Bern
Switzerland	Kantonsspital - St. Gallen	St. Gallen
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	C.R.C. Beatson Laboratories	Glasgow	Scotland
United Kingdom	Newcastle General Hospital	Newcastle Upon Tyne	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Netherlands,  Norway,  Switzerland,  United Kingdom, 

References & Publications (1)

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 — View Citation