Stage IV Ovarian Cancer Clinical Trial
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
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 peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. 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.
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 plus
OPT-821) decreases the hazard of progression or death compared to a vaccine containing
OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal cancer in
second or third complete clinical remission.
SECONDARY OBJECTIVES:
I. To compare the treatment arms with respect to the incidence of toxicities. II. To
determine if the polyvalent vaccine decreases the hazard of death compared to a vaccine
containing OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal
cancer in second or third complete clinical remission.
TERTIARY OBJECTIVES:
I. To evaluate the immune response (by enzyme linked immunosorbent assay [ELISA]) in
participants, in order to determine if the outcome correlates with antigen-specific immune
titers.
OUTLINE: 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.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01010126 -
Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
|
Phase 2 | |
| Terminated |
NCT00899093 -
YKL-40 in Serum Samples From Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy
|
||
| Completed |
NCT00301756 -
Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors
|
Phase 2 | |
| Completed |
NCT00262847 -
Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
|
Phase 3 | |
| Recruiting |
NCT01000259 -
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
|
N/A | |
| Completed |
NCT00066456 -
Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
|
Phase 1 | |
| Withdrawn |
NCT00551265 -
Oregovomab With or Without Cyclophosphamide in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Responded to Second-Line Chemotherapy
|
N/A | |
| Active, not recruiting |
NCT03188432 -
Hyperthermic Intraperitoneal Chemotherapy Trial Comparing Quality of Life in Patients With Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 2 | |
| Completed |
NCT03297489 -
Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer
|
Early Phase 1 | |
| Withdrawn |
NCT00053235 -
Research Study in Patients With Advanced Ovarian Epithelial Cancer
|
N/A | |
| Completed |
NCT00194714 -
Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab
|
Phase 1/Phase 2 | |
| Terminated |
NCT02441140 -
Detection of Tumor Associated Cell-free DNA in Peritoneal Fluid Obtained by Culdocentesis
|
N/A | |
| Completed |
NCT01131234 -
Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT00003532 -
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT01522820 -
Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors
|
Phase 1 | |
| Completed |
NCT01551745 -
Salvage Ovarian FANG™ Vaccine + Bevacizumab
|
Phase 2 | |
| Not yet recruiting |
NCT06315270 -
To Explore the Feasibility of Dynamic Changes of TCR Diversity in Peripheral Blood in Monitoring Recurrence and Evaluating Prognosis of Epithelial Ovarian Cancer
|
||
| Recruiting |
NCT05659381 -
Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer
|
Phase 3 | |
| Withdrawn |
NCT02872519 -
PET Imaging of Ovarian Carcinoma With 18F-FSPG
|
Early Phase 1 | |
| Withdrawn |
NCT02567396 -
Talazoparib in Treating Patients With Advanced or Metastatic Solid Tumors That Cannot Be Removed by Surgery and Liver or Kidney Dysfunction
|
Phase 1 |