View Clinical Trial (Medical Research Study)

A Phase II Randomized, Double-Blind Trial of a Polyvalent Vaccine-KLH Conjugate (NSC 748933) + OPT-821 Versus OPT-821 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Who Are in Second or Third Complete Remission

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Conditions:		Fallopian Tube Cancer - Ovarian Cancer - Primary Peritoneal Cavity Cancer
Purpose:		RATIONALE: Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more effective with or without vaccine therapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer. PURPOSE: This randomized phase III trial is studying OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer in second or third complete remission.
Study Summary:		OBJECTIVES: Primary - To determine if treatment with a polyvalent antigen-KLH conjugate vaccine (GM2-KLH, Globo-H-KLH, Tn-MUC1-32mer-KLH, and TF-KLH) in combination with immunological adjuvant OPT-821 decreases the hazard of progression or death compared to immunological adjuvant OPT-821 alone in patients with ovarian epithelial, fallopian tube, or peritoneal cancer in second or third complete clinical remission. Secondary - To compare the incidence of toxicities in patients treated with these regimens. Tertiary - To evaluate the immune response, in order to determine if the outcome correlates with antigen-specific immune titers. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive polyvalent antigen-KLH conjugate vaccine and immunological adjuvant OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71, and 83 in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive immunological adjuvant OPT-821 SC as in arm I. Blood samples are collected at baseline and periodically during study for immunological laboratory studies. Samples are analyzed for IgM and IgG titers and antibody expression to antigens (e.g., Tn-MUC1-32mer, GM2, Globo-H, TF, sTn, and Tn) by ELISA. After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Criteria:		DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer - Any stage or grade at diagnosis - Has undergone cytoreductive surgery and received ≥ 1 platinum-based chemotherapy regimen as part of primary treatment - Recurrent disease on or after initial primary therapy, but is now in a second or third complete clinical remission (after receiving ≥ 1 additional treatment within the past 4 months) as defined by the following: - Serum CA-125 normal - Negative physical examination - No definitive evidence of disease by CT scan of the abdomen and pelvis (lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm will not be considered definitive evidence of disease) - A positive PET scan is allowed provided other criteria are met and anatomical imaging (e.g., MRI or CT scan) is negative PATIENT CHARACTERISTICS: - GOG performance status 0-2 - ANC ≥ 1,000/mm^3 - Platelet count ≥ 100,000/mm^3 - Serum creatinine ≤ 1.5 times upper limit of normal (ULN) - Bilirubin ≤ 2.5 times ULN - SGOT and SGPT ≤ 2.5 times ULN - Alkaline phosphatase ≤ 2.5 times ULN - Not nursing - Negative pregnancy test - Fertile patients must agree to use an effective contraception - Able to complete study and required follow-up - No other invasive malignancies within the past 5 years, except for nonmelanoma skin cancer - No allergy to shellfish PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior cancer treatment that would preclude study treatment
NCT ID:		NCT00857545
Primary Contact:		Study Chair Paul Sabbatini, MD Memorial Sloan-Kettering Cancer Center
Backup Contact:		N/A
Location Contact:		Mentor, Ohio 44060 United States Joel N. Saltzman Phone: 440-205-5755 Site Status: Recruiting

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