A Phase I/II Randomized Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Detailed Description
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. This study has two Phases eligible subjects enrolled in Phase 1 will receive the OC-L admixed with Montanide ISA 51 with intravenous Ampligen. Subjects enrolled in Phase II will be randomized to two ARMS. This randomized design will allow for the unbiased evaluation and comparison of immune response among the 2 treatment arms. patients will be randomized (10 per treatment arm) in blocks of size 4 or 6, such that treatment assignment will be balanced after each group of 4 or 6 patients has been randomized. ARM A 10 patients will receive OC-L. Arm b 10 patients will receive OC-L with Ampligen. Following each vaccination, subjects in Phase I and Arm B will be given intravenous Ampligen 3 times starting 2-3 days after each vaccine administration. All subjects will receive vaccine on Day 0, 14, 28, 42 and 56. Subjects will receive Prevnar on day 0 and day 14. Subjects will be treated till exhaustion of OC-L or disease progression whichever occurs first subjects will be contacted every 6 months for up to 5 years and then annually for survival. The OC-L study product is manufactured and quality tested at Cell and Vaccine Production Facility and then released to IDS, where it will be admixed with Montanide ISA 51 VG on day of vaccination.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 \<
- •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).
Exclusion Criteria
- •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:
- •HTLV-1/2 Antibody,
- •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.
Outcomes
Primary Outcomes
Number of Participants With Adverse Events
Time Frame: within 30 days of last vaccination
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.
Secondary Outcomes
- Clinical Response(within 30 days of vaccination)
- Immune Response(within 30 days of vaccination)