Autologous OC-L Vaccine and Ovarian Cancer

NCT02452775 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: UPCC 40814
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized pilot trial to test the addition of 2 investigational agents, Montanide and poly-ICLC (a TLR3 agonist) to a backbone of autologous oxidized tumor cell lysate vaccine (OC-L) administered with GMCSF in subjects with primary epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Conditions

Primary Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Numbers of Adverse Events

  3.5 years

Study Arms (4)

Arm 1

EXPERIMENTAL

Subjects in ARM 1 will receive the vaccination with OC-L alone

Biological: OC-L

Arm 2

EXPERIMENTAL

subjects in ARM 2 will receive vaccination with OC-L admixed with Montanide,

Other: Montanide

Arm 3

EXPERIMENTAL

subjects in ARM3 will receive vaccination with OC-L admixed with 1 mg poly-ICLC (Hiltonol)

Other: poly-ICLC (Hiltonol),

Arm 4

EXPERIMENTAL

subjects in ARM 4 will receive vaccination with OC-L admixed with both Montanide and 1 mg poly-ICLC.

Biological: OC-L; Other: Montanide; Other: poly-ICLC (Hiltonol),

Interventions

OC-L BIOLOGICAL

Arm 1; Arm 4

Montanide OTHER

Arm 2; Arm 4

poly-ICLC (Hiltonol), OTHER

Arm 3; Arm 4

Eligibility Criteria

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

You may qualify if:

• Subject has primary ovarian (including low malignant potential), fallopian tube, or primary peritoneal cancer 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 has appropriate tissue available from the cytoreductive surgery tumor lysate preparation.
• Lysate must meet release criteria.
• Subject is 18 years of age or older.
• Subject has an 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.
• Subjects screened any time after completed last cycle of chemotherapy till progression or first recurrence of the disease.
• 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.

You may not qualify if:

• 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:
• HTLV-1/2
• Anti-HIV 1 Antibody (α-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.
• Subject has renal insufficiency as defined by a serum creatinine \> 2.2 mg/dl or BUN \> 40 mg/dl. Note: If creatinine is greater than 1.5 x ULN, creatinine clearance must be greater than 60ml/min.
• Subject has proteinuria \> 3.5 gm over 24 hrs are not eligible for the study
• Subject with liver failure as defined by a serum total bilirubin \> 2.0 and/or serum transaminases \> 3X the upper limits of normal.
• Subject has hematopoietic failure at baseline as defined by one of the following:
• Platelets \< 100,000/ mm3
• WBC \< 2,500/mm3
• Absolute Neutrophil Count (ANC) \< 1,000/mm3

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Ovarian Cancer Research Center: collaborator

Study Sites (1)

Ovarian Cancer Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Monatide (IMS 3015); poly ICLC

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 25, 2015
• Study Start: May 1, 2015
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)