|
Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer health trials take place in a lot of of cities across the US. 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 / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer. Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer  Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
For Condition: stage 2B cervical cancer,stage 4B cervical cancer,stage 1B cervical cancer,stage 1A cervical cancer,recurrent cervical cancer,stage 2A cervical cancer,stage 4A cervical cancer,stage 3 cervical cancer
Status: Suspended
Sponsor(s): Women and Infants Hospital of Rhode Island , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients with recurrent or persistent cervical cancer that cannot be treated with surgery or radiation therapy.
Details: OBJECTIVES: - Evaluate alternating vaccination with lipidated human papillomavirus 16 E7 peptide (HPV-16 E7) and autologous dendritic cells pulsed with immunogenic HPV-16 E7 in terms of toxicity, immunologic reactivity, and therapeutic efficacy in patients with recurrent or persistent cervical cancer. OUTLINE: This is a dose escalation study of dendritic cell-human papillomavirus 16 E7 (HPV-16 E7) peptide vaccine. Patients undergo leukapheresis to obtain peripheral blood mononuclear cells for activation to dendritic cells on days 0 and 28. Patients receive lipidated HPV-16 E7 peptide vaccine subcutaneously on days 1 and 14 and dendritic cell-HPV-16 E7 peptide vaccine IV over 15-30 minutes on days 7 and 21. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable disease or complete or partial response may receive one additional treatment course, beginning 6 weeks after the end of the first course. Cohorts of 3-9 patients receive escalating doses of dendritic cell-HPV-16 E7 peptide vaccine. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. A parallel cohort of patients receives dendritic cell-HPV-16 E7 peptide vaccine IV over 15-30 minutes on days 7 and 14, but does not receive lipidated HPV-16 E7 peptide. Patients are followed at one week. PROJECTED ACCRUAL: Approximately 27 patients will be accrued for this study at a rate of 15 patients per year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven recurrent or persistent cervical cancer not amenable to surgery or radiotherapy - Measurable and evaluable disease - HLA-A2 positive PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Greater than 3 months Hematopoietic: - WBC greater than 3,000/mm3 - Platelet count greater than 100,000/mm3 - Hemoglobin greater than 8.0 g/dL - No coagulation disorders Hepatic: - Bilirubin less than 2.0 mg/dL - SGOT less than 4 times upper limit of normal Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 75 mL/min Cardiovascular: - No major cardiovascular illness Pulmonary: - No major pulmonary illness Other: - HIV negative - Hepatitis B surface antigen negative - No active systemic infection - Not pregnant - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least one month since prior biologic therapy Chemotherapy: - At least one month since prior chemotherapy Endocrine therapy: - At least one month since prior endocrine therapy - No concurrent steroid therapy Radiotherapy: - See Disease Characteristics - At least one month since prior radiotherapy Surgery: - See Disease Characteristics - At least one month since prior surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelSteller, Study Chair, St. Elizabeth's Medical Center
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135-2997
United States
Additional Information:
Study ID Numbers: CDR0000067180; WIHRI-980016,NCI-T98-0072
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003977
Other Stage 2a Cervical Cancer Studies:
1. Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer
2. Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer
3. Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
4. Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer
5. Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
Related Studies:
Other stage 2A cervical cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
|
|
|
|
|
|
|
|
