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Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer. Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer  Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
For Condition: stage 4 ovarian epithelial cancer,peritoneal cavity cancer,stage 3 ovarian epithelial cancer,stage 2 ovarian epithelial cancer,Fallopian Tube Cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , 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 effect on the body of vaccine therapy in treating patients who have ovarian epithelial, primaryperitoneal, or fallopian tube cancer.
Details: OBJECTIVES: - Determine the safety of NY-ESO-1b peptide vaccine and Montanide ISA-51 in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer expressing NY-ESO-1 or LAGE-1. - Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients. OUTLINE: This is an open-label study. Patients receive NY-ESO-1b peptide vaccine emulsified with Montanide ISA-51 subcutaneously once every 3 weeks on weeks 1, 4, 7, 10, and 13 in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks and then every 6-12 weeks for 2 years or until disease progression. PROJECTED ACCRUAL: A total of 9 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 confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer - Stage II-IV at diagnosis - Previously treated with cytoreductive surgery and at least 1 platinum-based chemotherapy regimen - High-risk feature, defined as 1 of the following: - Suboptimal primary debulking (remaining tumor masses with diameter at least 1.0 cm) - Failure to normalize CA 125 during primary therapy by the end of the third course - Complete clinical remission, defined as all of the following: - CA 125 less than 35 units - Negative physical examination - No definite evidence of disease by CT scan of the abdomen and pelvis* NOTE: *Lymph nodes and/or soft tissue abnormalities in the pelvis, no greater than 1.0 cm, are not considered definite evidence of disease - HLA-A2 positive - Tumor expression of 1 of the following proteins: - NY-ESO-1 by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis or immunohistochemistry - LAGE-1 by RT-PCR - No more than 4 months since prior primary therapy - No CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - At least 6 months Hematopoietic - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 80,000/mm^3 - No bleeding disorders Hepatic - Bilirubin less than 2.5 times upper limit of normal (ULN) - ALT and AST less than 2.5 times ULN Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - No New York Heart Association class III or IV heart disease Other - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - No serious infections requiring antibiotics - No serious concurrent illness requiring hospitalization - No other malignancy within the past 3 years except treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No mental impairment that would preclude giving informed consent or complying with study requirements PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No concurrent chemotherapy Endocrine therapy - Concurrent tamoxifen is allowed - No concurrent systemic corticosteroids Radiotherapy - Not specified Surgery - See Disease Characteristics Other - More than 4 weeks since prior participation in any other investigational study - Concurrent non-cytotoxic anticancer therapy allowed - No concurrent immunosuppressive drugs - No concurrent nonsteroidal anti-inflammatory drugs except as low dose for the prevention of acute cardiovascular events or for pain control
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JakobDupont, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Jakob Dupont 212-639-8984
Additional Information:
Study ID Numbers: CDR0000318803; LUDWIG-LUD2002-014,MSKCC-03034
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066729
Other Stage 4 Ovarian Epithelial Cancer Studies:
1. Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
2. Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
3. Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
4. Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary Peritoneal Cancer
5. Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor
Related Studies:
Other stage 4 ovarian epithelial cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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