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Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors Clinical research trials and Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors. Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors clinical trial. Test subjects typically receive the most effective healthcare possible for their Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors  Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors
Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): EORTC New Drug Development Group ,
Synopsis: RATIONALE: Halofuginone hydrobromide may stop the growth of solid tumors by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of halofuginone hydrobromide in treating patients who have progressive advanced solid tumors.
Details: OBJECTIVES: - Determine the toxicity profile, maximum tolerated dose, and dose-limiting toxic effects of halofuginone hydrobromide in patients with progressive advanced solid tumors. - Establish a recommended dose of this drug for phase II study. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral halofuginone hydrobromide once daily on days 1 and 4-14 of course 1 and on days 1-14 of subsequent courses. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-3 patients receive escalating doses of halofuginone hydrobromide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 20% of patients experience acute dose-limiting toxicity. After the MTD is reached, 6-12 additional patients are treated at dose levels preceding the MTD until the recommended dose for phase II study is determined. The recommended dose for phase II study is defined as the dose preceding the MTD that allows a 90% dose intensity for 2 months with no greater than grade 2 toxicity in 80% of the patients. Patients are followed every 8 weeks until disease progression or initiation of another treatment. PROJECTED ACCRUAL: Approximately 7-40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced solid tumor that is not amenable to any clinical improvement by current standard treatments - No tumors of the upper digestive tract - No clinical signs of CNS involvement PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - WHO 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - WBC at least 3,000/mm^3 - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN - No unstable hepatobiliary disease that would preclude study Renal: - Creatinine no greater than 1.5 times ULN - No unstable renal disease that would preclude study Cardiovascular: - No unstable cardiovascular disease (e.g., stroke) that would preclude study Pulmonary: - No unstable pulmonary disease that would preclude study Gastrointestinal: - No digestive disease, including upper gastrointestinal tract, that would hamper absorption - No evident/known lactose malabsorption Other: - No allergy to components of the study drug - No uncontrolled infection - No other unstable systemic disease that would preclude study - No psychological, familial, sociological, or geographical condition that would preclude compliance - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior anticancer biologic therapy Chemotherapy: - At least 4 weeks since prior anticancer chemotherapy Endocrine therapy: - Prior anticancer hormonal therapy allowed Radiotherapy: - At least 6 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - At least 2 weeks since prior surgery Other: - At least 4 weeks since other prior anticancer treatment - No other concurrent anticancer agents or investigational therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MajaJonge, , Daniel Den Hoed Cancer Center at Erasmus Medical Center
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, , 3008 AE
Netherlands
University Hospital - Rotterdam Dijkzigt
Rotterdam, , 3000 CA
Netherlands
Additional Information:
Study ID Numbers: CDR0000069056; COLLGARD-EORTC-16007,EORTC-16007
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027677
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors
2. Vaccine Therapy in Treating Patients With Advanced Cancer
3. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
4. Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor
5. High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer
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Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors
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