Montanide and / or Poly-ICLC with Oxidized Tumor Cell Lysate Vaccine and Sargramostim in Treating Patients with Advanced Stage III-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Status: Active

Description

This randomized pilot early phase I trial studies montanide (montanide ISA 51 VG) and / or poly-ICLC with oxidized tumor cell lysate vaccine and sargramostim in treating patients with stage III-IV ovarian, primary peritoneal, or fallopian tube cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Biological therapies, such as montanide ISA 51 VG and poly-ICLC, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the production of blood cells. Giving montanide ISA 51 VG and / or poly-ICLC together with oxidized tumor cell lysate vaccine and sargramostim may be a better treatment for ovarian, primary peritoneal, or fallopian tube cancer.

Eligibility Criteria

Inclusion Criteria

  • Subject has primary ovarian (including low malignant potential), fallopian tube, or primary peritoneal cancer Federation of Gynecology and Obstetrics (FIGO) stage III or IV defined surgically at the completion of initial abdominal surgery
  • Subject has had cytoreductive surgery and has completed first line platinum based chemotherapy in an adjuvant or neo-adjuvant setting as part of standard of care treatment
  • Subject has no evidence of disease based on radiographical imaging * Subject was deemed to have a complete objective response at completion of primary platinum-based chemotherapy by computed tomography (CT) scan and cancer antigen (CA)-125
  • Subjects who have minimal CT scan findings suspicious of residual disease are eligible provided there is no evidence of progression of disease by Rustin Criteria, defined as: * Present CT Scan findings show no change from CT Scan at baseline, and * Current CA-125 is below institutional upper normal limit and remains unchanged upon two consecutive measurements at least one week apart, and * CA-125 was above institutional upper normal limit at diagnosis
  • Subject has appropriate tissue available from the cytoreductive surgery for tumor lysate preparation
  • Lysate must meet release criteria
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Subject understood and signed the study specific informed consent
  • Subjects screened between 1 to 12 weeks after last cycle of chemotherapy
  • Subject has recovered from toxicities of prior chemotherapy or other therapy (to grade 2 or less)
  • Subject has had at least 4 weeks of postoperative recovery from surgery prior to enrollment to ensure complete wound healing
  • Subjects who screen fails can be re-enrolled if the causation of the screen fail has been corrected

Exclusion Criteria

  • Subject for whom tumor lysate does not meet release criteria
  • Subject has a positive serum Yo antibody (does not need to be repeated if performed in the past)
  • Subject has a chronic or acute hepatitis C infection; subject with an old infection that has cleared may be included
  • Subject has a chronic or acute hepatitis B infection; subject with an old infection that has cleared may be included
  • Subject has positive test result at the screening visit for one or more of the following: * Human T-cell lymphotropic virus (HTLV-1/2) * Anti-human immunodeficiency virus (HIV) 1 antibody (alpha-HIV-1)
  • Subject requires or is likely to require more than a two-week course of corticosteroids for intercurrent illness; subject must complete the course of corticosteroids 2 weeks before screening to meet eligibility
  • Serum creatinine > 2.2 mg/dl or blood urea nitrogen (BUN) > 40 mg/dl; note: if creatinine is greater than 1.5 x upper limit of normal (ULN), creatinine clearance must be greater than 60ml/min
  • Subject has proteinuria > 3.5 gm over 24 hrs are not eligible for the study
  • Serum total bilirubin > 2.0 and/or serum transaminases > 3 X the upper limits of normal
  • Platelets < 100,000/ mm^3
  • White blood cell (WBC) < 2,500/mm^3
  • Absolute neutrophil count (ANC) < 1,000/mm^3
  • Absolute lymphocyte count < 200/ mm^3
  • Hematocrit < 30%
  • Subject has any acute infection that requires specific therapy; acute therapy must have been completed within seven days prior to study enrollment
  • Subject has a serious, non-healing wound, ulcer, or bone fracture
  • Subject has a clinically significant cardiovascular disease including: * Uncontrolled hypertension * Myocardial infarction or unstable angina within 6 months prior to enrollment * New York Heart Association (NYHA) grade II or greater congestive heart failure
  • Subject has a grade II or greater peripheral vascular disease
  • Subject has a clinically significant peripheral artery disease, e.g., those with claudication, within 6 months
  • Subject has any underlying conditions, which would contraindicate therapy with study treatment
  • Subject has organ allografts
  • Subject is receiving medication(s) that might affect immune function; use of histamine type 2 (H2) antagonists are prohibited as are all antihistamines five days before and five days after each injection of study vaccine; however, nonsteroidal antiinflammatory drugs (NSAIDS) including cyclooxygenase-2 (COX-2) inhibitors, acetaminophen or aspirin are permitted

Locations & Contacts

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Janos Laszlo Tanyi
Phone: 215-615-6815
Email: Janos.Tanyi@uphs.upenn.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine safety and feasibility of each treatment arm.

II. To determine immunological response rate by treatment arm.

SECONDARY OBJECTIVES:

I. To determine clinical response (Response Evaluation Criteria in Solid Tumors [RECIST]) rates by treatment arm.

II. To determine progression-free survival by treatment arm.

III. To investigate immunologic response, clinical response rates and progression-free survival by investigational agent, using 2-factor analyses.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I: Patients receive sargramostim subcutaneously (SC) on days 0-3, 21-24, 42-45, 63-66, and 84-87. Patients also receive oxidized tumor cell lysate vaccine (OC-L) vaccine intradermally on days 1, 2, 3, 22, 43, 64, and 85.

ARM II: Patients receive sargramostim and OC-L vaccine as in Arm I. Patients also receive montanide ISA 51 VG intradermally on days 1, 2, 3, 22, 43, 64, and 85.

ARM III: Patients receive sargramostim and OC-L vaccine as in Arm I. Patients also receive poly-ICLC intradermally on days 1, 2, 3, 22, 43, 64, and 85.

ARM IV: Patients receive sargramostim and OC-L vaccine as in Arm I, montanide ISA 51 VG as in Arm II, and poly-ICLC as in Arm III.

Patients who remain with no evidence of disease may have the option to continue on monthly maintenance with OC-L vaccine until exhaustion of the OC-L vaccine, disease progression, or at the discretion of the investigator, whichever occurs first.

After completion of study treatment, patients are followed up on day 106, every 3 months for 2 years, and then every 6 months for 3 years.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Treatment

Lead Organization

Lead Organization
University of Pennsylvania / Abramson Cancer Center

Principal Investigator
Janos Laszlo Tanyi

Trial IDs

Primary ID UPCC 40814
Secondary IDs NCI-2015-00878
Clinicaltrials.gov ID NCT02452775