|
Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors Clinical research trials and Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors health trials take place in a lot of of cities across the US. 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 / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors. Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors  Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors
Paclitaxel 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of paclitaxel and GEM 231 in treating patients who have recurrent or refractory solid tumors.
Details: OBJECTIVES: I. Determine the safety and maximum tolerated dose of GEM 231 and paclitaxel in patients with recurrent or refractory solid tumors. II. Determine any preliminary antitumor activity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation study of GEM 231. Patients receive paclitaxel IV over 3 hours on day 1, immediately followed by GEM 231 over 2 hours on days 1, 4, 8, 11, 15, and 18. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated with one of two doses of paclitaxel and escalating doses of GEM 231 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 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 with Gilbert's syndrome (no greater than 1.5 times ULN if liver metastases present); PT and aPTT normal; SGOT or SGPT less than 3 times ULN (no greater than 5 times ULN if liver metastases present) - 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; No known hypersensitivity to paclitaxel or other drugs formulated in Cremophor or any oligodeoxynucleotides; Adequate venous access; 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: CDR0000067518; AECM-1199906196,NCI-G00-1665,HYBRIDON-231-100B
Study Start Date: July 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004863
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. SU6668 in Treating Patients With Advanced Solid Tumors
2. Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors
3. Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors
4. Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors
5. LY293111 in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors
|
|
|
|
|
|
|
|
