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Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors 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 Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors Clinical research trials and Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors 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 Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors. Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors 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 Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors clinical trial. Human subjects often receive the most effective healthcare possible for their Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors 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 > "C" Clinical Trials Conditions > Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors  Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors
Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Mayo Clinic Cancer 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 combination chemotherapy with suramin plus doxorubicin in treating patients with advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of suramin followed by doxorubicin repeated every 4 weeks in patients with advanced solid tumors. II. Describe the toxic effects of suramin with sequential doses of doxorubicin. III. Assess the development of peripheral neuropathy in patients with this treatment. IV. Assess the preliminary evidence of the antitumor effect of suramin with doxorubicin. V. Determine the effect of suramin on total and free IGF-1, IGF-2 and IGF in association with high affinity binding proteins. VI. Explore the relationships between the pharmacokinetic parameters and potential neurotoxicity of suramin. PROTOCOL OUTLINE: This is a dose escalation study of doxorubicin. Patients receive tapering doses of suramin IV daily over 1-2 hours on days 1-4 followed by doxorubicin IV over 10-15 minutes on day 5. Treatment repeats every 4 weeks for up to 3 courses in the absence of unacceptable toxicity, disease progression, or clinical deterioration. Starting from course 4, patients receive alternating courses of doxorubicin IV on day 1 every 4 weeks (courses 4, 6, 8, etc.) and suramin with doxorubicin (courses 5, 7, 9 etc.) as described above. Cohorts of 3-6 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity. Stable patients who achieve disease response and are able to receive a target cumulative dose of doxorubicin may discontinue doxorubicin and receive suramin alone every 8 weeks. Patients are followed at 3 months. PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologic or cytologic confirmation of malignant solid tumor for which no other more conventional form of curative treatment is available, including but not limited to: Breast Cancer; Prostate Cancer; Colon Cancer; Adrenocortical tumors - No CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: More than 4 weeks since prior biologic therapy; More than 4 weeks since prior immunotherapy; No concurrent immunotherapy - Chemotherapy: More than 4 weeks since prior chemotherapy and recovered; More than 6 weeks since prior mitomycin or nitrosoureas; Prior doxorubicin dose less than 300 mg/m2 permitted; No concurrent chemotherapy; No more than 2 prior chemotherapy regimens for metastatic disease - Endocrine therapy: No current steroid use of greater than 1.5 mg dexamethasone (or equivalent) per day - Radiotherapy: More than 4 weeks since prior radiation therapy; No radiation therapy to greater than 25% of bone marrow No concurrent radiotherapy - Surgery: More than 4 weeks since prior major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Activated partial thromboplastin time (aPTT) no greater than upper limit of normal (ULN); Prothrombin time (PT) no greater than ULN - Hepatic: Direct bilirubin no greater than 1.5 times ULN; AST no greater than 2 times ULN; Albumin at least 3.0 g/dL - Renal: Creatinine clearance at least 50 mL/min; Na and K normal - Cardiovascular: Ejection fraction normal if prior doxorubicin therapy; No New York Heart Association class III/IV heart disease; No history of significant cardiac arrhythmia; No history of congestive heart failure - Metabolic: No insulin dependent diabetes mellitus - Neurologic: No seizure disorder; No grade 2 or greater peripheral neuropathy - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No uncontrolled infection; No chronic debilitating disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlexAdjei, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Additional Information:
Study ID Numbers: CDR0000065661; MAYO-960105,NCI-T97-0020
Study Start Date: October 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003038
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors
2. Octreotide and Doxorubicin in Treating Patients With Advanced Cancer
3. Ro 31-7453 in Treating Patients With Metastatic Solid Tumors
4. Paclitaxel and BMS-214662 in Treating Patients With Advanced Solid Tumors
5. PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors
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