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Cytochlor and Tetrahydrouridine as Radiosensitizers Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat) 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 Cytochlor and Tetrahydrouridine as Radiosensitizers Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Cytochlor and Tetrahydrouridine as Radiosensitizers Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat) Clinical research trials and Cytochlor and Tetrahydrouridine as Radiosensitizers Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat) 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 Cytochlor and Tetrahydrouridine as Radiosensitizers Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat). Cytochlor and Tetrahydrouridine as Radiosensitizers Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat) 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 Cytochlor and Tetrahydrouridine as Radiosensitizers Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat) clinical trial. Human subjects often receive the most effective healthcare possible for their Cytochlor and Tetrahydrouridine as Radiosensitizers Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat) 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 > Cytochlor and Tetrahydrouridine as Radiosensitizers Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat)  Cytochlor and Tetrahydrouridine as Radiosensitizers Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat)
Cytochlor and Tetrahydrouridine as Radiosensitizers Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat)
For Condition: stage 3 squamous cell carcinoma of the lip and oral cavity,stage 4 squamous cell carcinoma of the oropharynx,stage 4 squamous cell carcinoma of the lip and oral cavity,stage 3 squamous cell carcinoma of the oropharynx
Status: Not yet recruiting
Sponsor(s): Sylvester Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosensitizing drugs, such as cytochlor and tetrahydrouridine, may make tumor cells more sensitive to radiation therapy. Combining radiosensitizers with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining cytochlor and tetrahydrouridine with radiation therapy followed by radiation therapy alone in treating patients who have advanced squamous cell carcinoma of the oral cavity (mouth) or oropharynx (throat).
Details: OBJECTIVES: Primary - Determine the dose range of cytochlor to be used in phase II trials, based on safety, toxicity, and tissue selectivity, in patients with advanced squamous cell carcinoma of the oral cavity or oropharynx. - Determine the safety and toxicity profile of cytochlor, tetrahydrouridine, and concurrent radiotherapy followed by radiotherapy alone in these patients. - Determine the percentage of cancer cells vs normal cells that incorporate cytochlor in the DNA of patients treated with this regimen. - Determine the percentage replacement of thymine by 5-chlorouracil in tumors vs normal tissue of patients treated with this regimen. Secondary - Determine the tissue selectivity of this regimen in these patients. - Determine the level of cytochlor and its metabolites within the serum and urine of these patients during combination treatment and before radiotherapy alone is initiated. - Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is an open-label, dose-escalation study of cytochlor. Patients receive tetrahydrouridine IV followed by cytochlor IV for 3 days on week 1 and 5 days a week on weeks 2-4. Patients also undergo radiotherapy 5 days a week during weeks 2-7. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cytochlor until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 3 or 3 of 6 patients experience dose-limiting toxicity. Patients are followed at 1 month, monthly for 3 months, every 3 months for up to 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity or oropharynx - Stage III disease not eligible for surgery - Stage IV disease allowed if patient is not eligible for chemotherapy or refused chemotherapy - No distant metastasis - Previously untreated disease - No osteoradionecrosis in patients with tumors involving the maxilla - Tumor tissue/normal adjacent tissue (T/N) ratio for dC kinase and dCMP deaminase greater than 2.5 PATIENT CHARACTERISTICS: Age - Over 21 Performance status - Karnofsky 80-100% OR - ECOG 0-1 Life expectancy - More than 6 months Hematopoietic - Absolute neutrophil count greater than 1,500/mm^3 - WBC at least 3,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic - AST/ALT less than 2.5 times upper limit of normal - Bilirubin normal Renal - Creatinine normal OR - Creatinine clearance greater than 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No impending carotid rupture Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study treatment - HIV negative - No other concurrent uncontrolled illness - No active or ongoing infection - No alcohol dependence - No psychiatric illness or social situation that would preclude study compliance - No other malignancy within the past 3 years except low-risk, non-melanomatous skin cancer, carcinoma in situ (e.g., breast, cervix, or bladder), or stage T1-2, low-to-moderate grade prostate cancer (Gleason score no greater than 7) PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy Chemotherapy - See Disease Characteristics - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy except contraceptives or replacement steroids Radiotherapy - Not specified Surgery - See Disease Characteristics Other - No prior therapy for head and neck cancer - No other concurrent experimental medications - No other concurrent anticancer therapy - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LuisRaez, Study Chair, Sylvester Cancer Center
Additional Information:
Study ID Numbers: CDR0000352184; NCI-6301,SCCC-2002033
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077051
Other Stage 4 Squamous Cell Carcinoma Of The Oropharynx Studies:
1. Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx
2. Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer
3. Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer
4. Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat
5. Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer
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Cytochlor and Tetrahydrouridine as Radiosensitizers Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat)
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