|
Phenoxodiol in Treating Patients With Refractory 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 Phenoxodiol in Treating Patients With Refractory Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phenoxodiol in Treating Patients With Refractory Solid Tumors Clinical research trials and Phenoxodiol in Treating Patients With Refractory 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 Phenoxodiol in Treating Patients With Refractory Solid Tumors. Phenoxodiol in Treating Patients With Refractory 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 Phenoxodiol in Treating Patients With Refractory Solid Tumors clinical trial. Test subjects typically receive the most expert healthcare available for their Phenoxodiol in Treating Patients With Refractory 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.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Phenoxodiol in Treating Patients With Refractory Solid Tumors  Phenoxodiol in Treating Patients With Refractory Solid Tumors
Phenoxodiol in Treating Patients With Refractory Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Novogen ,
Synopsis: RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractorysolid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors. - Determine the steady-state pharmacokinetics of this drug in these patients. - Determine the tumor response in patients treated with this drug. OUTLINE: This is a multicenter, dose-escalation study. Patients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of phenoxodiol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 4 weeks. PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed solid tumor - Refractory to standard therapy OR - No standard therapy exists - No breast cancer - No active CNS metastases - Known CNS metastases must be previously treated with radiotherapy or surgery and stable for at least 4 weeks prior to study PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 3 months Hematopoietic: - Platelet count greater than 100,000/mm^3 - WBC greater than 3,000/mm^3 - Neutrophil count greater than 1,500/mm^3 - Hemoglobin greater than 10 g/dL (9 g/dL for women) Hepatic: - Bilirubin less than 1.2 mg/dL - Transaminases no greater than 3 times upper limit of normal Renal: - Creatinine no greater than 1.4 mg/dL Other: - No active infection - No contraindication to the insertion of a vascular access device - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent systemic anticancer immunotherapy Chemotherapy: - No concurrent systemic anticancer chemotherapy Endocrine therapy: - No concurrent systemic anticancer hormonal therapy except luteinizing hormone-releasing hormone agonists or antagonists Radiotherapy: - See Disease Characteristics - Concurrent localized radiotherapy for control of local disease complications allowed Surgery: - See Disease Characteristics Other: - Recovered from prior antineoplastic therapy - At least 4 weeks since prior investigational agents - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GrahamKelly, Study Chair, Novogen
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Ronald Bukowski 216-444-6825
Additional Information:
Study ID Numbers: CDR0000068802; NOVOGEN-NV06-0024,NCI-V01-1663,CCF-4269
Study Start Date:
Record last reviewed: September 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022295
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
2. SR-45023A in Treating Patients With Advanced Solid Tumors
3. Tirapazamine, Carboplatin, and Paclitaxel in Treating Patients With Advanced Malignant Solid Tumors
4. Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
5. Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Phenoxodiol in Treating Patients With Refractory Solid Tumors
|
|
|
|
|
|
|
|
