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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003982 |
Purpose
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 MEN-10755 in treating patients who have solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Testicular Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific |
Drug: sabarubicin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study to Determine the Safety of MEN-10755 (BMS-195615) in Patients With a Solid Tumor on a Short I.V. Infusion Given Once Every Week for 3 Consecutive Weeks, Followed by One Week's Rest |
| Estimated Enrollment: | 30 |
| Study Start Date: | June 1997 |
OBJECTIVES: I. Determine the maximum tolerated dose of MEN-10755 in patients with solid tumors. II. Determine the qualitative and quantitative toxic effects of this drug and study the predictability, duration, intensity, onset, reversibility and dose relationship of the toxic effects in this patient population. III. Propose a safe dose for phase II study. IV. Study the pharmacokinetics of this drug at different dose levels in this patient population.
V. Document any possible antitumor activity of this drug in this patient population.
OUTLINE: This is a dose escalation study. Patients receive MEN-10755 IV over 15 minutes on days 1, 8, and 15.
Treatment continues every 4 weeks, or upon recovery of toxicity, whichever comes later. Treatment continues for at least 2 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of MEN-10755 until the 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. Patients are followed for at least 3 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor that is not amenable to standard therapy Measurable or evaluable disease No brain involvement or leptomeningeal disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin no greater than 1.5 mg/dL Liver function tests no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: LVEF at least 50% (by MUGA) Other: Not pregnant or nursing Fertile patients must use effective contraception No active infections No other nonmalignant disease that precludes study No history of alcoholism, drug addiction, or psychotic disorders
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, and high dose carboplatin) No other concurrent antitumor drugs Endocrine therapy: No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) No concurrent radiotherapy Surgery: Not specified Other: No prior anthracyclines or anthracenediones No other concurrent investigational drugs
Contacts and Locations| Austria | |
| Innsbruck Universitaetsklinik | |
| Innsbruck, Austria, A-6020 | |
| Kaiser Franz Josef Hospital | |
| Vienna, Austria, A-1100 | |
| Belgium | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Ludwig Institute for Cancer Research-Brussels Branch | |
| Brussels, Belgium, B-1200 | |
| Denmark | |
| Herlev Hospital - University Hospital of Copenhagen | |
| Herlev, Denmark, DK-2730 | |
| France | |
| Centre Jean Perrin | |
| Clermont-Ferrand, France, 63011 | |
| Centre Leon Berard | |
| Lyon, France, 69373 | |
| CRLCC Nantes - Atlantique | |
| Nantes-Saint Herblain, France, 44805 | |
| Institut Claudius Regaud | |
| Toulouse, France, 31052 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Germany | |
| Klinikum Nurnberg | |
| Nuremberg (Nurnberg), Germany, D-90419 | |
| Universitaetsklinik und Strahlenklinik - Essen | |
| Essen, Germany, D-45122 | |
| Netherlands | |
| Academisch Ziekenhuis der Vrije Universiteit | |
| Amsterdam, Netherlands, 1117 MB | |
| Academisch Ziekenhuis Groningen | |
| Groningen, Netherlands, 9713 EZ | |
| Antoni van Leeuwenhoekhuis | |
| Amsterdam, Netherlands, 1066 CX | |
| Rotterdam Cancer Institute | |
| Rotterdam, Netherlands, 3075 EA | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6252 HB | |
| Norway | |
| Norwegian Radium Hospital | |
| Oslo, Norway, N-0310 | |
| Switzerland | |
| Inselspital, Bern | |
| Bern, Switzerland, CH-3010 | |
| Kantonsspital - Saint Gallen | |
| Saint Gallen, Switzerland, CH-9007 | |
| University Hospital | |
| Basel, Switzerland, CH-4031 | |
| United Kingdom, England | |
| Newcastle General Hospital | |
| Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
| United Kingdom, Scotland | |
| Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 9NQ | |
| Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| C.R.C. Beatson Laboratories | |
| Glasgow, Scotland, United Kingdom, G61 1BD | |
| Study Chair: | Emma Geertruida Elisabeth De Vries, MD, PhD | University Medical Centre Groningen |
More Information
| Study ID Numbers: | CDR0000067186, EORTC-16970 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003982 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific testicular embryonal carcinoma and yolk sac tumor |
|
Neoplasms, Germ Cell and Embryonal Carcinoma |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
