A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
NCT ID: NCT01312389
Last Updated: 2021-11-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
3 participants
INTERVENTIONAL
2011-04-30
2012-08-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 2: 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.
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.
Prevnar
A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
Phase 2: 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.
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.
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.
Prevnar
A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
Phase 1
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.
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.
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.
Prevnar
A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
Interventions
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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.
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.
Prevnar
A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
Eligibility Criteria
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Inclusion Criteria
* 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 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%
18 Years
FEMALE
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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Janos Tanyi, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Locations
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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UPCC 29810
Identifier Type: -
Identifier Source: org_study_id