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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
Open (Enrolling)
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



- 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.


- To compare the incidence of toxicities in patients treated with these regimens.


- 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


- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal

- 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


- 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

- No allergy to shellfish


- See Disease Characteristics

- No prior cancer treatment that would preclude study treatment

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:


Principal Investigator

Paul Sabbatini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




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



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