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Chemotherapy in Treating Patients With Advanced Solid Tumors Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Chemotherapy in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Chemotherapy in Treating Patients With Advanced Solid Tumors Clinical research trials and Chemotherapy in Treating Patients With Advanced Solid Tumors medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Chemotherapy in Treating Patients With Advanced Solid Tumors. Chemotherapy in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy in Treating Patients With Advanced Solid Tumors clinical trial. Participants oftentimes recieve the finest healthcare available for their Chemotherapy in Treating Patients With Advanced Solid Tumors condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Patients With Advanced Solid Tumors  Chemotherapy in Treating Patients With Advanced Solid Tumors
Chemotherapy in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Jewish General Hospital
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 chemotherapy using sarCNU in patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of SarCNU in patients with advanced solid malignancies. II. Determine the toxic effects of SarCNU in these patients. III. Characterize the pharmacokinetic profile of this regimen in these patients. IV. Determine any evidence of antineoplastic activity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive oral SarCNU on days 1, 5, and 9. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SarCNU 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. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven advanced solid malignancy for which no curative or life extending therapy exists - No prior or concurrent CNS metastases; Primary CNS tumors allowed if on a stable dose of steroids at least 2 weeks prior to study entry - No myelodysplastic syndrome --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior biologic therapy; No concurrent immunotherapy - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin); No concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy - Radiotherapy: At least 3 weeks since prior radiotherapy; No radiotherapy to greater than 25% bone marrow; No concurrent radiotherapy - Surgery: At least 21 days since major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: More than 12 weeks - Hematopoietic: Absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 120,000/mm3; Hemoglobin greater than 8 g/dL - Hepatic: Bilirubin normal; SGOT or SGPT less than 2.5 times upper limit of normal - Renal: Creatinine less then 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min - Cardiovascular: No uncontrolled cardiac disease; No uncontrolled hypertension - Pulmonary: DLCO and vital capacity greater than 80% predicted - Other: Not pregnant or nursing; Fertile patients must use effective contraception; HIV negative; Oral intake at least 1,200 calories per day; No serious concurrent illness or uncontrolled infection; No recent weight loss of greater than 10% actual body weight
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LawrencePanasci, Study Chair, Jewish General Hospital
Jewish General Hospital - Montreal
Montreal, Quebec, H3T 1E2
Canada
Additional Information:
Study ID Numbers: CDR0000066810; JGH-CR97097,NCI-T98-0015,CR-97-0917,CR9809NI
Study Start Date: January 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003703
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy
2. UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
3. XK469 in Treating Patients With Advanced Solid Tumors
4. Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors
5. R115777 in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Quebec Clinical Trials
Other Montreal Clinical Trials
Chemotherapy in Treating Patients With Advanced Solid Tumors
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