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Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix Clinical research trials and Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix. Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix  Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix
Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix
For Condition: stage 4 cervical cancer,cervical adenosquamous cell carcinoma,cervical squamous cell carcinoma,recurrent cervical cancer,cervical adenocarcinoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cervical cancer cells. PURPOSE: Phase II trial to study the effectiveness of interleukin-12 in treating patients with advanced or recurrent cancer of the cervix.
Details: OBJECTIVES: I. Determine the response rates, duration of response, and survival in women with advanced, recurrent, or inoperable cervical cancer treated with interleukin-12. II. Determine the toxic effects of systemic interleukin-12 in these patients. III. Correlate response to therapy and survival with the presence or absence of human papilloma virus (HPV), and the specific subtype of HPV, in these patients. PROTOCOL OUTLINE: Patients are stratified according to prior chemotherapy (yes vs no). Patients receive induction interleukin-12 IV over 5-20 seconds on day -13 and then daily on days 1-5. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 78 patients (39 per stratum) will be accrued for this study within 26 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven stage IV or recurrent squamous cell, adenosquamous, or adenocarcinoma of the uterine cervix including: Lung, liver, lymph node, or skin metastases OR Retroperitoneal disease OR Other advanced measurable disease OR Positive paraaortic lymph nodes - Measurable disease that is beyond the scope of conventional radiation therapy or surgery, or recurrent after radiation therapy or surgery - Measurable, recurrent disease within a previously irradiated field must have increased in size by 100% on at least 2 successive scans, MRI, or physical examinations --Prior/Concurrent Therapy-- - Biologic therapy: 1 prior biologic therapy allowed; At least 4 weeks since prior biologic therapy - Chemotherapy: 1 prior adjuvant chemotherapy regimen allowed 1 prior chemotherapy regimen for advanced disease allowed; At least 4 weeks since prior chemotherapy; No concurrent chemotherapy - Endocrine therapy: No concurrent steroid therapy; No concurrent megestrol acetate - Radiotherapy: See Disease Characteristics; No concurrent radiotherapy - Surgery: See Disease Characteristics; At least 2 weeks since prior surgery --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times the upper limit of normal (ULN); AST and ALT no greater than 2 times ULN - Renal: Creatinine no greater than 2.0 mg/dL; Creatinine clearance at least 60 mL/min - Cardiovascular: No New York Heart Association class III/IV heart disease; No uncontrolled congestive heart failure or angina - Pulmonary: No chronic obstructive pulmonary disease - Gastrointestinal: No evidence of active gastrointestinal bleeding; No active peptic ulcer disease; No inflammatory bowel disease - Other: Normal diet required; No known active infections; HIV negative; AIDS-related complex (ARC) negative; No substance abuse or psychiatric problems; No evidence of autoimmune disease; No other prior invasive malignancy except resected basal cell or squamous cell skin cancer; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottWadler, Study Chair, Eastern Cooperative Oncology Group
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: CDR0000065597; E-1E96
Study Start Date: July 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003017
Other Recurrent Cervical Cancer Studies:
1. Comparison of Cisplatin Combined With Either Paclitaxel or Gemcitabine in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer
2. SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
3. Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
4. Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix
5. Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
Related Studies:
Other recurrent cervical cancer Clinical Trials
Other New Jersey Clinical Trials
Other Flemington Clinical Trials
Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix
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