Status:
COMPLETED
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
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage IA Fallopian Tube Cancer
Stage IA Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies 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 ...
Detailed Description
PRIMARY OBJECTIVES: I. To determine if a polyvalent vaccine (including GM2-keyhole limpet hemocyanin \[KLH\], Globo-H-KLH, Tn-mucin 1 \[MUC1\]-32mer-KLH, and Thompson Friedreich antigen \[TF\]-KLH pl...
Eligibility Criteria
Inclusion
- Patients with histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, of any stage or grade at diagnosis; all patients must have had cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment
- Patients who recurred on or after initial therapy, and are now in a second or third complete clinical remission and who are within four months of their last treatment are eligible; complete clinical remission is defined as serum cancer antigen (CA)-125 within institutional normal limits, negative physical examination, and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis; lymph nodes and/or soft tissue abnormalities =\< 1.0 cm are often present in the pelvis and will not be considered definite evidence of disease; eligibility is determined by anatomical imaging only (ie. magnetic resonance imaging \[MRI\] or CT); a positive positron emission tomography (PET) image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative
- Absolute neutrophil count (ANC) greater than or equal to 1,000/mm\^3, equivalent to Common Toxicity Criteria for Adverse Events (CTCAE version \[v\]4.0) grade 1
- Platelets greater than or equal to 100,000/mm\^3
- Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1
- Bilirubin less than or equal to 2.5 x ULN
- Serum glutamic oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminse (SGPT) less than or equal to 2.5 x ULN
- Alkaline phosphatase less than or equal to 2.5 x ULN
- Patients must have a Gynecological Oncology Group (GOG) performance status of 0, 1, or 2
- Patients who have signed the informed consent document and signed the authorization permitting release of personal health information
- Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing an effective form of birth control; nursing mothers are excluded
Exclusion
- With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded
- Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up
- Patients who have an allergy to shellfish
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00857545
Start Date
July 1 2010
Last Update
September 13 2017
Active Locations (46)
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1
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36688
2
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
3
Stanford Cancer Institute
Palo Alto, California, United States, 94304
4
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115