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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, 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:

United States: Food and Drug Administration

Study ID:

GOG-0255

NCT ID:

NCT00857545

Start Date:

August 2010

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity 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
  • 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 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
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Winthrop University HospitalMineola, New York  11501
University of South Alabama Mitchell Cancer InstituteMobile, Alabama  36604
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Beebe Medical CenterLewes, Delaware  19958
Miami Valley HospitalDayton, Ohio  45409
Greater Baltimore Medical CenterBaltimore, Maryland  21204
AnMed Health Cancer CenterAnderson, South Carolina  29621
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Northwestern UniversityChicago, Illinois  60611
Case Western Reserve UniversityCleveland, Ohio  44106
Huntsman Cancer Institute/University of UtahSalt Lake City, Utah  84112
Virginia Commonwealth UniversityRichmond, Virginia  
University of CincinnatiCincinnati, Ohio  45267-0502
Froedtert and the Medical College of WisconsinMilwaukee, Wisconsin  53226
Northside HospitalAtlanta, Georgia  30342
Kettering Medical CenterKettering, Ohio  45429
University of ToledoToledo, Ohio  43614
Greenville CCOPGreenville, South Carolina  29615
Upstate Carolina CCOPSpartanburg, South Carolina  29303
University of California Medical Center At Irvine-Orange CampusOrange, California  92868
Women and Infants HospitalProvidence, Rhode Island  02905
Lake University Ireland Cancer CenterMentor, Ohio  44060
Cancer Centers of the Carolinas - FarisGreenville, South Carolina  29605
Gynecologic Oncology of West Michigan PLLCGrand Rapids, Michigan  49546
Center of Hope at Renown Medical CenterReno, Nevada  89502
Carilion Clinic Gynecological OncologyRoanoke, Virginia  24016
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida  33136
Southwest Gynecologic Oncology Associates IncAlbuquerque, New Mexico  87106
Women's Cancer Center of NevadaLas Vegas, Nevada  89109
Central DuPage Hospital Cancer CenterWarrenville, Illinois  60555
Saint Francis HospitalGreenville, South Carolina  29601
Stanford University Hospitals and ClinicsStanford, California  94305
Saint Vincent Oncology CenterIndianapolis, Indiana  46260
The Women's Institute for Gynecologic Cancer and Special Pelvic SurgeryPhillipsburg, New Jersey  08865
Summa Akron City HospitalAkron, Ohio  44304
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
UCSF-Mount ZionSan Francisco, California  94115