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A PILOT STUDY OF A POLYVALENT VACCINE-KLH CONJUGATE + OPT-821 GIVEN IN COMBINATION WITH BEVACIZUMAB IN PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN SECOND OR GREATER COMPLETE OR PARTIAL CLINICAL REMISSION


N/A
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tubes Cancer, Ovarian Cancer, Peritoneal Cancer

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Trial Information

A PILOT STUDY OF A POLYVALENT VACCINE-KLH CONJUGATE + OPT-821 GIVEN IN COMBINATION WITH BEVACIZUMAB IN PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN SECOND OR GREATER COMPLETE OR PARTIAL CLINICAL REMISSION


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to Day 1

- History of abdominal fistula or gastrointestinal perforation within 6 months prior to
Day

- Patients with clinical symptoms or signs of GI obstruction who require parenteral
hydration, parenteral nutrition, or tube feeding

- Patients with evidence of abdominal free air not explained by paracentesis or recent
surgical procedure

- Serious, non-healing wound, active ulcer, or untreated bone fracture

- Known hypersensitivity to any component of bevacizumab

- Allergy to seafood

- Active autoimmune disease (i.e. rheumatoid arthritis, ulcerative colitis etc); or
immune deficiency (HIV, hypogammaglobulinemia); or known active infections with
Hepatitis B or Hepatitis C; or those receiving immunosuppressive drugs (such as
chronic systemic corticosteroids or cyclosporin, etc); or those receiving chronic
antiinflammatory drugs (intermittent use of anti-inflammatory drugs is permitted).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the safety of immunization with polyvalent antigen - KLH + OPT-821 vaccine conjugate

Outcome Description:

in combination with bevacizumab in patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Paul Sabbatini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

10-099

NCT ID:

NCT01223235

Start Date:

October 2010

Completion Date:

October 2013

Related Keywords:

  • Fallopian Tubes Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • FALLOPIAN TUBE
  • OVARY
  • PERITONEUM
  • BEVACIZUMAB (AVASTIN)
  • GLOBO H-KLH CONJUGATE
  • MUC-1 KLH
  • OPT-821
  • TF (C) - KLH
  • TN(C)-KLH
  • 10-099
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021