A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer

NCT01312389 | Terminated Phase 1 Results DMC

• 1 other identifier: UPCC 29810
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L) administered by intradermal/subcutaneous injection in combination with Ampligen (poly-l:poly-C12U), a Toll-like receptor 3 agonist. Study duration is 24 months.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version 4.0). All toxicities observed within 30 days of last vaccination will be included. All patients that receive at least one vaccination will be included in the toxicity analysis.

  within 30 days of last vaccination

Secondary Outcomes (2)

• Immune Response

  within 30 days of vaccination

• Clinical Response

  within 30 days of vaccination

Study Arms (3)

Phase 2: Arm A

EXPERIMENTAL

10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions.

Biological: OC-L/Montanide ISA 51 VG; Biological: Prevnar

Phase 2: Arm B

EXPERIMENTAL

10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions, administered in combination with intravenous Ampligen.

Biological: OC-L/Montanide ISA 51 VG; Biological: Ampligen; Biological: Prevnar

Phase 1

EXPERIMENTAL

3 patients will be enrolled receiving the vaccine (tumor lysate/Montanide) plus Ampligen using a 3+3 approach. If no DLTs in the first three subjects, we will move to phase II; if one 1/3 subject develops DLTs, we will enroll 3 additional subjects; if 2/6 subjects develop DLTs, we will discontinue the study. Following completion of run---in phase I (3 or 6 subjects), we will transition to Phase 2.

Biological: OC-L/Montanide ISA 51 VG; Biological: Ampligen; Biological: Prevnar

Interventions

OC-L/Montanide ISA 51 VG BIOLOGICAL

All subjects will receive OC-L/Montanide ISA 51 VG) on day 0, 14,28,42 and 56 with a +/- 5 day window. The vaccine will be divided in two or more intradermal/subcutaneous injections in the groin areas bilaterally.

Phase 1; Phase 2: Arm A; Phase 2: Arm B

Ampligen BIOLOGICAL

All subjects will receive intravenous Ampligen (200mg given by IV infusion 60 +- minutes) 3 times starting 2-3 days after each vaccine administration. Each of the 3 Ampligen (200 mg) infusions will be separated by 2-3 days.

Phase 1; Phase 2: Arm B

Prevnar BIOLOGICAL

A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.

Phase 1; Phase 2: Arm A; Phase 2: Arm B

Eligibility Criteria

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

You may qualify if:

• Subject has recurrent ovarian (including low malignant potential), fallopian tube or primary peritoneal cancer and has already received front line platinum based chemotherapy prior to recurrence.
• Subject has had prior secondary cytoreductive surgery yielding tumor for Lysate preparation.
• Lysate must meet release criteria.
• Subject has a current largest tumor nodule that is \>1 cm CT or MRI.
• Subject is 18 years of age or older.
• Subject has an ECOG performance status of \<1.
• Subject has a life expectancy of \>6 months.
• Subject must understand and sign the study specific informed consent.
• Subject may have received chemotherapy or other therapy after harvest of tumor and prior to enrollment but must have recovered from toxicities of prior chemotherapy or other therapy (to grade 2 or less).
• Subject may have received prior investigational therapy (including immune therapy).
• Subject may have received prior hormonal therapy.
• Subject may have received prior radiation therapy but must have completed such therapy prior to enrollment.
• Subject 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
• Subject has a chronic or acute hepatitis C infection.
• Subject has a chronic or acute hepatitis B infection.
• Subject has positive test result at the screening visit for one or more of the following: 1. HTLV-1/2 Antibody, 2. Anti-HIV 1/2 Antibody
• 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. Note: If creatinine is greater than 1.5 x ULN, creatinine clearance must be greater than 50 ml/min.
• 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 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 known allergies to reagents used in this study.
• Subject has organ allograft.
• Subject is receiving medications that might effect immune function. Use of H2 antagonists are prohibited, as are all antihistamines five days before and five days after each injection of study vaccine. However, NSAIDS including COX-2 inhibitors, acetaminophen or aspirin are permitted.
• Subject has clinical symptoms or signs of partial or complete gastrointestinal obstruction or requires parenteral hydration and/or nutrition.
• Subject has hematopoietic failure at baseline as defined by one of the following:

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

poly(I).poly(c12,U); Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: Director of Clinical Trial Operations
• Organization: University of Pennsylvania

tracey.thomas@pennmedicine.upenn.edu

215-662-3324

Study Officials

• Janos Tanyi, MD, Ph.D

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: March 1, 2011
• First Posted: March 10, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: August 17, 2012
• Last Updated: November 15, 2021
• Results First Posted: November 15, 2021

Record last verified: 2021-10

Locations

US (1)