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Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck Clinical research trials and Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck health trials occur in a lot of of places throughout 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck. Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck clinical trial. Human subjects frequently get the finest healthcare available for their Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck  Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck
Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck
For Condition: Head and Neck Neoplasms
Status: Recruiting
Sponsor(s): BioCure Medical , Duke University,Medical University of South Carolina
Synopsis: The purpose of this study will be to determine the safety and tolerability of intratumoral M4N. Patients suffering from cancer of the head and neck that is recurrent after primary treatment with surgery, radiation therapy, and/or chemotherapy may be eligible. The design is a Phase 1 dose escalation study of M4N administered intratumorally once weekly, initially for three weeks. Dose will be escalated on the starting schedule to a target of 20 mg/cm3 tumor volume and then, new patient cohorts will have their schedule extended to weekly M4N for 4 weeks. Dose escalation will continue, assuming tolerability, so that cohorts will be treated for 6 weeks, and finally, 8 weeks.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: Major Inclusion Criteria: - Male or female patients >18 years of age. - Patients with documented histologic evidence of head and neck cancer with clinically measurable disease. Head and neck cancer can be recurrent after primary treatment with surgery, radiation therapy and/or chemotherapy. - ECOG Performance Status of 0, 1, or 2. - Absolute neutrophil 1500/uL, hemoglobin 8 gm %, platelets 50,000/uL, - ALT/AST ï‚£3 x ULN (upper limit of the normal range), bilirubin 1.5 x ULN and creatinine 1.5 x ULN, PT and PTT within normal limits.
Total Enrollment: 28
Location and Contact Information:
MUSC *Recruiting*
Charleston, South Carolina, 29475
United States
Recruiting Betsy Sass 843-792-6325
Additional Information:
Study ID Numbers: M4N001;
Study Start Date: January 2003
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057512
Other Head And Neck Neoplasms Studies:
1. Study Of Zd1839 (Iressaâ„¢) Versus Methotrexate For Previously Treated Patients With Squamous Cell Carcinoma Of The Head And Neck
2. An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck
3. Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck
4. Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
5. Phase II Trial of Allovectin-7® for Head and Neck Cancer
Related Studies:
Other Head and Neck Neoplasms Clinical Trials
Other South Carolina Clinical Trials
Other Charleston Clinical Trials
Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients with Refractory Malignant Tumors of the Head and Neck
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