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ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy Clinical research trials and ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy. ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy clinical trial. Human subjects often receive the most effective healthcare possible for their ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy  ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy
ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: ILX23-7553 may help solid tumor cells develop into normal cells. PURPOSE: Phase I trial to study the effectiveness of ILX23-7553 in treating patients who have solid tumors that have not responded to previous therapy.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of ILX23-7553 in patients with refractory solid tumors. II. Determine the principal and dose limiting toxicities of this treatment regimen in terms of duration and reversibility in this patient population. III. Determine the preliminary evidence of antitumor activity with this treatment regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation, multicenter study. Patients receive oral ILX23-7553 for 5 days. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ILX23-7553 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 10 patients experience dose limiting toxicity. Patients are followed monthly for at least 2 months. PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed solid tumor refractory to conventional therapy or for which no standard therapy exists - Measurable or evaluable disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered; No concurrent curative antineoplastic drugs - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No concurrent curative radiotherapy - Surgery: At least 4 weeks since prior surgery and recovered - Other: At least 30 days since prior investigational agents At least 2 weeks since prior vitamin D, calcium supplementation, or cholestyramine; No concurrent vitamin D, calcium supplementation, or cholestyramine; No concurrent digoxin; No concurrent hypercalcemia therapy (i.e., biphosphonates or insulin) --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL - Hepatic: Bilirubin no greater than 2.0 mg/dL (regardless of liver metastases); SGOT/SGPT no greater than 2 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL; Calcium no greater than 9.5 mg/dL; No nephrocalcinosis - Cardiovascular: No congestive heart failure; No angina or ischemia - Other: Ability to swallow or nasogastric or gastrostomy tube present; Adequate organ and immune system function; No known hypersensitivity to ILX23-7553 or analogues HIV negative; No active uncontrolled infection; No other severe disease or psychiatric disorder that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenSoignet, Study Chair, Memorial Sloan-Kettering Cancer Center
New Jersey Medical School
Newark, New Jersey, 07103-2714
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067610; MSKCC-99078,NCI-G00-1699,ILEX-VITD-101-A1
Study Start Date: October 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004926
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor
2. GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
3. GPX-100 in Treating Patients With Solid Tumors
4. EMD 121974 in Treating Patients With Advanced Solid Tumors
5. Improving Pain Management in Patients With Nonhematologic Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
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ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy
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