Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01312389
First received: March 1, 2011
Last updated: April 16, 2012
Last verified: April 2012

March 1, 2011
April 16, 2012
March 2011
March 2013   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events [ Time Frame: within 30 days of last vaccination ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01312389 on ClinicalTrials.gov Archive Site
  • Immune Response [ Designated as safety issue: Yes ]
    Immune response will be evaluated by IFN-g ELISPOT analysis of tumor-reactive T cells, and in HLA-A2+ subjects, by tetramer analysis of Her-2 specific T cells in peripheral blood. Response is defined by a > 3 fold increase relative to pre-vaccination.
  • Clinical Response [ Designated as safety issue: Yes ]
    Clinical Response will be estimated using immune related response criteria ir(RC)
Same as current
Not Provided
Not Provided
 
A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
A Phase I/II Randomized Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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 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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Biological: OC-L/Montanide ISA 51 VG
    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.
  • Biological: Ampligen
    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.
  • Biological: Prevnar
    A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
  • Experimental: Arm A
    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.
    Interventions:
    • Biological: OC-L/Montanide ISA 51 VG
    • Biological: Ampligen
    • Biological: Prevnar
  • Experimental: Arm B
    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.
    Interventions:
    • Biological: OC-L/Montanide ISA 51 VG
    • Biological: Ampligen
    • Biological: Prevnar
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
29
March 2013
March 2013   (final data collection date for primary outcome measure)

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 <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.

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: 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:

    1. Platelets<100,000/mm 3
    2. WBC < 2,500/mm3
    3. Absolute Neutrophil Count (ANC) < 1,500/mm3
    4. Absolute lymphocyte count <200/mm 3
    5. Hematocrit < 30%
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01312389
UPCC 29810
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Principal Investigator: George Coukos, MD, Ph.D Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP