Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

1. 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

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

Tertiary

1. To evaluate the immune response, in order to determine if the outcome correlates with antigen-specific immune titers.

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior cancer treatment that would preclude study treatment

Patient Characteristics:

• GOG performance status 0-2
• ANC ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

Outcomes

Progression-free survival

Overall survival
Frequency and severity of adverse effects as assessed by NCI CTCAE v4.0 criteria
Correlation of outcome 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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Paul Sabbatini, MD, Protocol chair		Ph: 212-639-6423; 800-525-2225

U.S.A.
California
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph:  650-498-7061
			Email: cctoffice@stanford.edu
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-623-4450
Florida
	Miami
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service	Ph:  866-574-5124
			Email: Sylvester@emergingmed.com
Georgia
	Atlanta
	Northside Hospital Cancer Center
		Clinical Trials Office - Northside Hospital Cancer Center	Ph:  404-303-3355
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Ph:  312-695-1301
			Email: cancer@northwestern.edu
Maryland
	Baltimore
	Greater Baltimore Medical Center Cancer Center
		Clinical Trials Office - Greater Baltimore Medical Center Cancer Center	Ph:  443-849-3706
	Elkton MD
	Union Hospital of Cecil County
		Mark Borowsky	Ph:  410-398-4000
Missouri
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		David Mutch, MD	Ph:  314-362-3181
Nevada
	Las Vegas
	Women's Cancer Center - La Canada
		Nick Spirtos, MD	Ph:  408-866-3843
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Peter Lim	Ph:  775-982-5050 866-559-0558
New Jersey
	Phillipsburg
	Women’s Institute for Gynecologic Cancer and Special Pelvic Surgery
		David Silver, MD	Ph:  702-427-4999
New Mexico
	Albuquerque
	Southwest Gynecologic Oncology Associates, Incorporated
		Carolyn Muller, MD	Ph:  505-272-0185
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Paul Sabbatini, MD	Ph:  212-639-6423
North Carolina
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
Ohio
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		William Richards	Ph:  806-796-1317
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	Dayton
	David L. Rike Cancer Center at Miami Valley Hospital
		Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital	Ph:  937-208-2079
	Mentor
	Lake/University Ireland Cancer Center
		Joel Saltzman	Ph:  440-205-5755
	Toledo
	Medical University of Ohio Cancer Center
		Clinical Trials Office - Medical University of Ohio Cancer Center	Ph:  419-383-6583
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Robert Mannel, MD	Ph:  405-271-8787
Pennsylvania
	Abington
	Rosenfeld Cancer Center at Abington Memorial Hospital
		Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital	Ph:  215-481-2402
South Carolina
	Greenville
	Cancer Centers of the Carolinas - Faris Road
		Larry Puls	Ph:  864-679-3900
	CCOP - Greenville
		Larry Puls	Ph:  864-241-6251
	Spartanburg
	Cancer Centers of the Carolinas - Spartanburg
		Larry Puls	Ph:  864-699-5700
Utah
	Salt Lake City
	Huntsman Cancer Institute at University of Utah
		Clinical Trials Office - Huntsman Cancer Institute at University of Utah	Ph:  801-581-4477
			Email: clinical.trials@hci.utah.edu
Virginia
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center	Ph:  804-628-1939

Registry Information
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
Trial Start Date		2010-08-10
Trial Completion Date		2012-06-02 (estimated)
Registered in ClinicalTrials.gov		NCT00857545
Date Submitted to PDQ		2009-02-23
Information Last Verified		2012-05-19
NCI Grant/Contract Number		CA27469

Back to Top