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
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
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 University | Baltimore, Maryland 21205 |
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
| Winthrop University Hospital | Mineola, New York 11501 |
| University of South Alabama Mitchell Cancer Institute | Mobile, Alabama 36604 |
| University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
| Beebe Medical Center | Lewes, Delaware 19958 |
| Miami Valley Hospital | Dayton, Ohio 45409 |
| Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
| AnMed Health Cancer Center | Anderson, South Carolina 29621 |
| Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
| Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
| Northwestern University | Chicago, Illinois 60611 |
| Case Western Reserve University | Cleveland, Ohio 44106 |
| Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
| Virginia Commonwealth University | Richmond, Virginia |
| University of Cincinnati | Cincinnati, Ohio 45267-0502 |
| Froedtert and the Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Northside Hospital | Atlanta, Georgia 30342 |
| Kettering Medical Center | Kettering, Ohio 45429 |
| University of Toledo | Toledo, Ohio 43614 |
| Greenville CCOP | Greenville, South Carolina 29615 |
| Upstate Carolina CCOP | Spartanburg, South Carolina 29303 |
| University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
| Women and Infants Hospital | Providence, Rhode Island 02905 |
| Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
| Cancer Centers of the Carolinas - Faris | Greenville, South Carolina 29605 |
| Gynecologic Oncology of West Michigan PLLC | Grand Rapids, Michigan 49546 |
| Center of Hope at Renown Medical Center | Reno, Nevada 89502 |
| Carilion Clinic Gynecological Oncology | Roanoke, Virginia 24016 |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida 33136 |
| Southwest Gynecologic Oncology Associates Inc | Albuquerque, New Mexico 87106 |
| Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
| Central DuPage Hospital Cancer Center | Warrenville, Illinois 60555 |
| Saint Francis Hospital | Greenville, South Carolina 29601 |
| Stanford University Hospitals and Clinics | Stanford, California 94305 |
| Saint Vincent Oncology Center | Indianapolis, Indiana 46260 |
| The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery | Phillipsburg, New Jersey 08865 |
| Summa Akron City Hospital | Akron, Ohio 44304 |
| Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
| UCSF-Mount Zion | San Francisco, California 94115 |
