OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00857545
First received: March 5, 2009
Last updated: May 28, 2013
Last verified: May 2013
  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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Biological: immunological adjuvant OPT-821
Biological: polyvalent antigen-KLH conjugate vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by NCI CTCAE v4.0 criteria [ Designated as safety issue: Yes ]
  • Correlation of outcome with antigen-specific immune titers [ Designated as safety issue: No ]

Estimated Enrollment: 164
Study Start Date: August 2010
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: immunological adjuvant OPT-821
Given subcutaneously
Biological: polyvalent antigen-KLH conjugate vaccine
Given subcutaneously
Experimental: Arm II
Patients receive immunological adjuvant OPT-821 SC as in arm I.
Biological: immunological adjuvant OPT-821
Given subcutaneously

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857545

  Show 45 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Paul Sabbatini, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00857545     History of Changes
Other Study ID Numbers: GOG-0255, NCI-2009-01176
Study First Received: March 5, 2009
Last Updated: May 28, 2013
Health Authority: United States: Food and Drug Administration
United States: National Cancer Institute

Keywords provided by Gynecologic Oncology Group:
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014