|
Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal 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 Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical research trials and Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal 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 Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer. Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal 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 Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal 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.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer  Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
For Condition: peritoneal cavity cancer,stage 2 ovarian epithelial cancer,stage 4 ovarian epithelial cancer,stage 3 ovarian epithelial cancer,Fallopian Tube Cancer,recurrent ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from monoclonal antibodies combined with tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: Randomizedphase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian epithelial, fallopian tube, or peritoneal cancer.
Details: OBJECTIVES: - Determine the safety of varying routes and doses of monoclonal antibody ACA125 anti-idiotype vaccine in patients with ovarian epithelial, fallopian tube, or peritoneal cancer. - Determine an optimal dose and route of this vaccine for a phase II study. - Determine the immune response induced by this vaccination in these patients. - Determine the time to development of objective tumor response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 treatment arms. - Arm I: Patients receive lower-dose monoclonal antibody ACA125 anti-idiotype vaccine (MOAB ACA125) intramuscularly (IM) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive higher-dose MOAB ACA125 IM as in arm I. - Arm III: Patients receive lower-dose MOAB ACA125 subcutaneously (SC) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity. - Arm IV: Patients receive higher-dose MOAB ACA125 SC as in arm III. Patients are followed every 6-12 weeks for 2 years. PROJECTED ACCRUAL: A total of 40 patients (10 patients per cohort) 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, fallopian tube, or peritoneal cancer - Stage II-IV - Initially treated with surgery and at least 1 platinum-based chemotherapy regimen - Must have relapsed after initial treatment and completed chemotherapy for recurrent disease - Asymptomatic residual measurable disease on CT scan and/or an elevated CA 125 allowed - Complete clinical remission allowed, defined by the following criteria: - CA 125 no greater than 35 IU/mL - No objective evidence of disease by CT scan - Normal physical examination PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - At least 3 months Hematopoietic - WBC at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin no greater than 2 times normal - ALT no greater than 2 times normal - Alkaline phosphatase no greater than 2 times normal Renal - Creatinine no greater than 1.5 times normal Other - Not pregnant or nursing - No potential for child bearing - Human antimurine antibody negative - HIV negative - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No active infection - No known autoimmune disease (e.g., rheumatoid arthritis or ulcerative colitis) - No known immune deficiency (e.g., hypogammaglobulinemia) - No known allergy to murine proteins PRIOR CONCURRENT THERAPY: Biologic therapy - At least 6 weeks since prior interferon - At least 6 weeks since prior immunotherapy or biological response modifiers - No prior anticancer vaccine Chemotherapy - See Disease Characteristics - At least 3 weeks since prior cytotoxic or investigational chemotherapy Endocrine therapy - No concurrent steroids Radiotherapy - At least 4 weeks since prior radiotherapy Surgery - See Disease Characteristics Other - At least 1 week since prior antibiotics - No concurrent cyclosporine - No other concurrent immunosuppressive therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulSabbatini, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Elizabeth Poynor 212-639-5092
Additional Information:
Study ID Numbers: CDR0000288831; CELLCONTROL-MSKCC-02122,MSKCC-02122
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058435
Other Stage 2 Ovarian Epithelial Cancer Studies:
1. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Persistent or Platinum Refractory Stage III or IV Ovarian Cancer
2. Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
3. Carboplatin With or Without Liposomal Doxorubicin in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
4. Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
5. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Related Studies:
Other stage 2 ovarian epithelial cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
|
|
|
|
|
|
|
|
