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Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors Clinical research trials and Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors. Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors clinical trial. Test subjects typically receive the most expert healthcare available for their Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors  Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors
Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): ILEX Oncology ,
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 intoplicine in treating patients who have advanced or metastatic solid tumors.
Details: OBJECTIVES: I. Determine the intolerable dose level of intoplicine in patients with locally advanced or metastatic cancer. II. Determine recommended phase II dose of intoplicine in these patients. III. Determine the principal and dose limiting toxicities of intoplicine in these patients, and determine the duration and reversibility of the toxicities. IV. Determine the magnitude of plasma concentrations that are achieved and maintained on this regimen and relate this parameter to toxicity outcome and antitumor activity. V. Determine preliminary evidence of antitumor activity of intoplicine in these patients. PROTOCOL OUTLINE: This is a dose escalation study. The first 3 patients receive intoplicine IV by continuous infusion for 5 days. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Subsequent cohorts of 3-6 patients receive escalating doses of intoplicine, first by increasing the number of days that the drug is infused to 10, 15, and 21, then by increasing the dosage and keeping the infusion time constant at 21 days. The intolerable dose level is defined as the lowest dose at which at least 2 of 3 or 6 patients experience dose limiting toxicity during course 1 or 2. PROJECTED ACCRUAL: A total of 20-35 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 or cytologically proven solid tumor refractory to conventional cytotoxic anticancer therapy or for which no curative therapy exists - Measurable or evaluable disease - No active, progressive brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered; No other concurrent antineoplastic therapy - Endocrine therapy: Not specified - Radiotherapy: At least 3 weeks since prior radiotherapy (except short courses (no greater than 5 fractions) of nonmyelosuppressive, palliative radiotherapy) and recovered; No concurrent radiotherapy - Surgery: Not specified - Other: At least 3 weeks since prior investigational therapy; No other concurrent investigational therapy --Patient Characteristics-- - Age: 18 and over - Performance status: SWOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT/SGPT no greater than 3 times upper limit of normal; No nonmalignant hepatic disease - Renal: Creatinine no greater than 2.0 mg/dL; Potassium and magnesium at least lower limit of normal (LLN); Calcium at least LLN - Cardiovascular: QTc interval on echocardiogram less than 450 milliseconds; No myocardial infarction within past 6 months; No uncontrolled congestive heart failure; No unstable angina; No active cardiomyopathy; No unstable ventricular arrhythmia; No uncontrolled hypertension - Other: Not pregnant or nursing; Fertile patients must use effective contraception; Must have functional central venous access device or percutaneous intravenous catheter; No known hypersensitivity to intoplicine or its analogs; No active alcoholism or drug addiction; No uncontrolled, unstable psychotic disorders; No serious infections; No underlying medical conditions that may be aggravated by treatment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KateNolte, Study Chair, ILEX Oncology
San Antonio Cancer Institute
San Antonio, Texas, 78229
United States
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Additional Information:
Study ID Numbers: CDR0000066821; ILEX-INTO101-A6,NCI-V98-1507,ILEX-INTO101-A5,SACI-IDD-97-02,UTHSC-9785011033
Study Start Date: August 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003713
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Benzoylphenylurea in Treating Patients With Advanced Solid Tumors
2. LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases
3. E7389 in Treating Patients With Advanced Solid Tumors
4. Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors
5. Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
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Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors
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