Polyvalent Vaccine-KLH Conjugate + Opt-821 Given in Combination With Bevacizumab

NCT01223235 | Completed Results DMC

• 1 other identifier: 10-099
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The immune system of the body has the ability to fight and eliminate infections and cancers. Immune treatments, such as in this study, seek to teach the immune system to find and destroy cancer cells. The purpose of this study is to test whether it is safe to treat the cancer with a vaccine and another drug called bevacizumab (also known as Avastin).

Conditions

Fallopian Tubes Cancer; Ovarian Cancer; Peritoneal Cancer

Keywords

FALLOPIAN TUBE; OVARY; PERITONEUM; BEVACIZUMAB (AVASTIN); GLOBO H-KLH CONJUGATE; MUC-1 KLH; OPT-821; TF (C) - KLH; TN(C)-KLH; 10-099

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Toxicities evaluated by CTCAE version 4.0

  1 year

Secondary Outcomes (2)

• Percentage of Participants Who Met the Immunogenicity Criteria (>/=3 Antigens) of the Vaccine

  1 year

• Progression-free Survival as Assessed By Multiplex Biomarker Panel of Angiogenesis Markers

  Up to 24 months

Study Arms (1)

bevacizumab & polyvalent vaccine-KLH conjugate + OPT-821

EXPERIMENTAL

This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Biological: bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821

Interventions

bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 BIOLOGICAL

A maximum of 6 doses of the polyvalent-KLH vaccine and OPT-821 will be administered to each patient as per the schedule. Bevacizumab will be administered once every two weeks until week 11 and then once every three weeks according to the schedule. When the 6 vaccinations of the polyvalent-KLH vaccine +OPT821 are completed, patients may still continue to receive bevacizumab on the once every three week schedule.

bevacizumab & polyvalent vaccine-KLH conjugate + OPT-821

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented epithelial carcinoma arising in the ovary, fallopian tube or peritoneum.
• Patients who have received cytoreductive surgery and chemotherapy with at least one platinum based chemotherapy regimen. Patients who received neoadjuvant chemotherapy are eligible.
• Patients with relapsed ovarian, fallopian tube or primary peritoneal cancer who have now completed chemotherapy and/or surgery for recurrent disease. Eligible patients are those who would be appropriate to enter a period of observation if standard management were considered.
• Patients who have asymptomatic residual measurable disease on CT scan or be in complete clinical remission. Patients may have an elevated CA-125. (Complete clinical remission is defined as serum CA-125 ≤ 35 IU/ml, negative physical examination and without objective evidence of disease by computed tomography (CT) of the abdomen and pelvis.)
• Adequate hematologic, coagulation, renal and hepatic function.
• ANC \> = to 1,000 cells/mm3; platelets \> or = 100,000 cells/mm3
• PT such that international normalized ratio (INR) is \< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) Serum creatinine \< or = to 1.5 mg/dl
• Bilirubin, SGOT, Alk Phos \< 2.5x upper limit normal
• Urine protein : creatinine (UPC) ratio must be \< 1 . If UPC ratio \> 1, collection of 24-hour urine measurement of urine protein is recommended as part of the patient's medical management off-study.
• Karnofsky performance status \> 70%
• Expected survival of at least 4 months
• Age ≥ 18 years. This protocol does not include children because the number of children with cancer is limited, and because a nationwide pediatric cancer research network already accesses the majority. Furthermore, the incidence of ovarian, fallopian tube, or peritoneal cancer in children is extremely infrequent.
• Patients who are ≥ 4 weeks from completion of prior cytotoxic chemotherapy. Prior bevacizumab and/or immunotherapy treatment are permitted

You may not qualify if:

• Inability to comply with study and/or follow-up procedures
• Current or recent (within 4 weeks of the first infusion of this study) participation in another experimental drug study.
• Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years
• Patients must have undergone standard cytoreductive surgery as part of primary treatment to be eligible for this study and therefore are not of childbearing potential.Nursing mothers are excluded.
• Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 90 mmHg)
• Prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix C)
• History of myocardial infarction or unstable angina within 6 months prior to Day 1
• History of stroke or transient ischemic attack within 6 months prior to Day 1
• Known CNS disease, except for treated brain metastasis
• Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded
• Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
• History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) or tumor involving major vessels.
• Major surgical procedure such as laparotomy, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Kahn RM, Ragupathi G, Zhou QC, Iasonos A, Kravetz S, Hensley ML, Konner JA, Makker V, Tew WP, Aghajanian C, Sabbatini PJ, O'Cearbhaill RE. Long-term outcomes of patients with recurrent ovarian cancer treated with a polyvalent vaccine with bevacizumab combination. Cancer Immunol Immunother. 2023 Jan;72(1):183-191. doi: 10.1007/s00262-022-03225-1. Epub 2022 Jul 2.

  PMID: 35779095 DERIVED

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Paul Sabbatini, MD
• Organization: Memorial Sloan Kettering Cancer Center

sabbatip@mskcc.org

212-639-4016

Study Officials

• Paul Sabbatini, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 12, 2018
• Results First Posted: May 14, 2018

Record last verified: 2017-09

Locations

US (1)