A Randomized Phase III Trial in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer With a Polyvalent Vaccine-KLH Conjugate + OPT-821 Versus OPT-821
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Trial Information
A Randomized Phase III Trial in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer With a Polyvalent Vaccine-KLH Conjugate + OPT-821 Versus OPT-821
OBJECTIVES:
Primary
- To compare the progression-free survival of patients with ovarian epithelial, fallopian
tube, or primary peritoneal cancer in second or third complete clinical remission
treated with a polyvalent antigen-KLH conjugate vaccine (GM2-KLH, Globo-H-KLH,
Tn-MUC1-32mer-KLH, TF-KLH, and sTn-KLH) in combination with OPT-821 vs OPT-821 alone.
Secondary
- To compare the incidence of toxicities in patients treated with these regimens.
- To compare the overall survival of patients treated with these regimens.
- To characterize the immune response (by ELISA) in a limited sampling of patients, 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 in combination with
OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87.
- Arm II: Patients receive OPT-821 SC once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75,
and 87.
Patients undergo blood sample collection periodically for correlative studies. Samples are
analyzed for antibody expression to antigens (i.e., Tn-MUC1-32mer, GM2, Globo-H, TF, sTN,
and Tn) by ELISA. IgM and IgG titers are also measured.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
cancer
- Any stage or grade at diagnosis allowed
- Has undergone initial cytoreductive surgery or received at least one platinum-based
chemotherapy regimen
- Recurred on initial therapy, but is now in second or third complete clinical
remission 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 are not considered
definitive evidence of disease)
- A positive PET scan is allowed provided other criteria are met and MRI
or CT scan are negative
- Completed last course of chemotherapy within the past 4 months
PATIENT CHARACTERISTICS:
- GOG performance status 0-2
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.0 times ULN
- SGOT ≤ 2.0 times ULN
- Alkaline phosphatase ≤ 2.0 times ULN
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Safety Issue:
No
Principal Investigator
Paul Sabbatini, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
Unspecified
Study ID:
CDR0000597674
NCT ID:
NCT00693342
Start Date:
August 2008
Completion Date:
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- stage IA primary peritoneal cavity cancer
- stage IB primary peritoneal cavity cancer
- stage IC primary peritoneal cavity cancer
- stage IIA primary peritoneal cavity cancer
- stage IIB primary peritoneal cavity cancer
- stage IIC primary peritoneal cavity cancer
- stage IIIA primary peritoneal cavity cancer
- stage IIIB primary peritoneal cavity cancer
- stage IIIC primary peritoneal cavity cancer
- stage IV primary peritoneal cavity cancer
- stage IA fallopian tube cancer
- stage IB fallopian tube cancer
- stage IC fallopian tube cancer
- stage IIA fallopian tube cancer
- stage IIB fallopian tube cancer
- stage IIC fallopian tube cancer
- stage IIIA fallopian tube cancer
- stage IIIB fallopian tube cancer
- stage IIIC fallopian tube cancer
- stage IV fallopian tube cancer
- stage IA ovarian epithelial cancer
- stage IB ovarian epithelial cancer
- stage IC ovarian epithelial cancer
- stage IIA ovarian epithelial cancer
- stage IIB ovarian epithelial cancer
- stage IIC ovarian epithelial cancer
- stage IIIA ovarian epithelial cancer
- stage IIIB ovarian epithelial cancer
- stage IIIC ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
- Neoplasms, Glandular and Epithelial
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