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Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors Clinical research trials and Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors. Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors clinical trial. Human subjects often obtain the finest healthcare possible for their Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors  Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors
Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Albert Einstein Cancer Research Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Gene therapy such as GEM 231 may inhibit the growth of cancer cells and make the tumor more sensitive to chemotherapy. PURPOSE: Phase I trial to study the effectiveness of combining docetaxel and GEM 231 in treating patients who have recurrent or refractory solid tumors.
Details: OBJECTIVES: I. Determine the safety and maximum tolerated dose of docetaxel and GEM 231 in patients with recurrent or refractory solid tumors. II. Determine any preliminary antitumor activity of GEM 231 in this patient population. PROTOCOL OUTLINE: This is a dose escalation study of GEM 231 and docetaxel. Patients receive docetaxel IV over 1 hour on day 1, immediately followed by GEM 231 IV over 2 hours on days 1, 4, 8, and 11. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated with escalating doses of GEM 231 and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 3 months. PROJECTED ACCRUAL: A maximum of 1 patient will be accrued per week for this study until the maximum tolerated dose is reached.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists - Measurable or evaluable disease - No CNS metastases that are untreated, associated with seizures, or require intravenous medication and/or hospitalization --Prior/Concurrent Therapy-- - Biologic therapy: At least 1 week since prior transfusion; Prior biologic therapy allowed and recovered; No other concurrent biologic therapy - Chemotherapy: Prior chemotherapy allowed and recovered; No other concurrent chemotherapy - Endocrine therapy: Prior hormonal therapy allowed and recovered; Concurrent palliative hormonal therapy allowed - Radiotherapy: Prior radiotherapy allowed and recovered; No concurrent radiotherapy (except palliative) - Surgery: At least 2 weeks since prior major surgery with wound complications - Other: At least 2 weeks since prior investigational drugs; No other investigational drugs during or within 28 days of study; No concurrent CYP-3A metabolism dependent drugs --Patient Characteristics-- - Age: 18 and over - Performance status: WHO 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 8.5 g/dL - Hepatic: Bilirubin no greater than upper limit of normal (ULN), except Gilbert's syndrome; PT and aPTT normal; SGOT or SGPT less than 3 times ULN - Renal: Creatinine less than 1.25 times ULN; No renal tubular dysfunction (i.e., at least 2+ proteinuria within the past 2 weeks) - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception for 1 month prior to, during, and 3 months after study; No other serious medical condition that would prevent compliance; No serious infection; Adequate venous access; No known hypersensitivity to docetaxel or any oligodeoxynucleotides; No prior peripheral neuropathy greater than grade 2; No psychological or geographical condition that would prevent compliance
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SridharMani, Study Chair, Albert Einstein Cancer Research Center
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Additional Information:
Study ID Numbers: CDR0000067520; AECM-1199906197,NCI-G00-1666,HYBRIDON-231-100A
Study Start Date: July 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004864
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors
2. Geldanamycin Analogue in Treating Patients With Advanced Cancer
3. Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
4. Bizelesin in Treating Patients With Advanced Cancer
5. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors
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