Trial record 1 of 1 for:    NCT00857545
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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: August 8, 2014
Last verified: August 2014
  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. 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.


Condition Intervention Phase
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Stage I Ovarian Epithelial Cancer
Stage II Ovarian Epithelial Cancer
Stage III Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer
Biological: immunological adjuvant OPT-821
Biological: polyvalent antigen-KLH conjugate vaccine
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 [ Time Frame: From randomization to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
    Will be characterized by treatment group with Kaplan-Meier plots and estimates of the median time until death or progression. In addition, the following exploratory analyses will be done. A stratified log-rank test will be used to examine whether the two treatment groups are different after stratifying by second or third CR. Patients in third CR have not been shown to have shorter PFS compared to patients in second CR; historically 10% of patients in clinical trials are in third CR. Second, a Cox proportional hazards model will be used to test the interaction of treatment arm and 2nd/3rd CR.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: From entry onto the protocol to death due to any cause, or for living patients, date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    Will be characterized by treatment group with Kaplan-Meier plots and estimates of the median time until death. The log rank test will be used to compare treatment groups with respect to overall survival.

  • Frequency and severity of adverse effects as assessed by NCI CTCAE v4.0 criteria [ Time Frame: Up to 87 weeks ] [ Designated as safety issue: Yes ]
    Will be summarized with descriptive statistics for the patients in the safety analysis dataset.

  • Correlation of outcome with antigen-specific immune titers [ Time Frame: Up to 83 weeks ] [ Designated as safety issue: No ]
    Analyses will be conducted on the measures of immune response to assess the effects of the study regimens on these endpoints and to determine whether these endpoints are associated with clinical outcomes (PFS and overall survival). Immune response will be measured at repeated time points (week 1 [prior to treatment], and weeks 11, 17, 23, 35, 47, 59, 71, and 83). Therefore, the relationship of immune response with PFS and overall survival will be examined with Cox proportional hazards models with immune response as a time-dependent covariate.


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

Detailed Description:

PRIMARY OBJECTIVES:

I. 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 OBJECTIVES:

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

TERTIARY OBJECTIVES:

I. 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

Inclusion Criteria:

  • 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
  • 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
  • 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 46 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Paul Sabbatini Gynecologic Oncology Group
  More 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, CDR0000636384, GOG-0255, GOG-0255, GOG-0255, U10CA027469
Study First Received: March 5, 2009
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 18, 2014