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A Phase I Clinical Trial of Autologous Dendritic Cell Vaccine Leaded With Autologous Tumor Cell Lysate for Recurrent Ovarian or Primary Peritoneal Cancer

Phase 1
18 Years
Not Enrolling
Ovarian Cancer, Peritoneal Cancer

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Trial Information

A Phase I Clinical Trial of Autologous Dendritic Cell Vaccine Leaded With Autologous Tumor Cell Lysate for Recurrent Ovarian or Primary Peritoneal Cancer

Subjects with recurrent epithelial ovarian carcinoma or recurrent primary peritoneal cancer,
for whom autologous tumor or malignant effusion has been harvested and is available for
lysate preparation, are eligible, provided all other eligibility criteria are fulfilled.
Harvested tumor or malignant effusion will be shipped to Cognate BioServices (Sunnyvale, CA)
for preparation of lysate. If sufficient amount of lysate for vaccine can be generated,
subjects will be enrolled to the study.

Subjects will undergo apheresis on day -35 to -29 to harvest peripheral blood mononuclear
cells (PBMC). The apheresis product will be shipped to Cognate BioServices, where DC will be
prepared and pulsed with autologous lysate according to proprietary technology. Following
apheresis, subjects will receive two cycles of biological antiangiogenesis/immunomodulatory
therapy comprising intravenous bevacizumab at 10 mg/kg on day -28 and -14, which may be
followed by 7 days of oral metronomic cyclophosphamide at 50 mg daily (days -28 to -21, and
-14 to -7, respectively). Subjects will receive three doses of intradermal vaccination with
~5-10 x 106 dendritic cells (DCVax-L) on days 0, 14 and 28. Subjects will also receive
intravenous bevacizumab at 10 mg/kg concurrently with intradermal DCVax-L on day 0 and 14,
which may be followed by oral cyclophosphamide at 50 mg for 7 days (days 0 to 7, and 14 to
21, respectively). The last DCVax-L (day 28) may be followed by oral cyclophosphamide at 50
mg daily x 7 days (days 28 to 35), but no bevacizumab will be given on day 28. Prevnar, an
FDA approved seven-valent vaccine against Pneumococcus pneumoniae, will be given
intramuscularly on day 0 as positive control of immune responsiveness. Two weeks following
third vaccine dose (day 42), patients will undergo immune assessment.

Subjects will be contacted every 6 months for 5 years and then annually for survival.
Subject will have the option of enrolling in other combinatorial immunotherapy trials when
these are available, if they satisfy enrollment criteria. Subjects will have the option of
continuing vaccination every two months till exhaustion of DCVax-L or disease progression,
whichever occurs first.

Inclusion Criteria:

- Recurrent stage II to IV ovarian carcinoma or primary peritoneal carcinoma.

- Subjects with prior secondary cytoreductive surgery or aspiration of malignant
effusion yielding tumor for lysate preparation.

- Subjects must have sufficient lysate for DCVax-L preparation (> 10 mg of pure protein
lysate from tumor, ascites or malignant pleural effusion cell preparation).

- largest tumor nodule ≤ 2.5 cm

- Patients who have achieved complete response following surgery and chemotherapy are
still eligible for vaccine.

- may be platinum-sensitive or platinum-resistant

- may have received chemotherapy or other therapy after harvest of tumor

- must have recovered from toxicities of prior chemotherapy or other therapy.

- completed all parenteral investigational therapy 14 days and have completed all oral
investigational therapy 7 days prior to enrollment

- must have completed all hormonal therapy 7 days prior to enrollment.

- must have recovered from toxicities of radiation therapy (to grade 2 or less).

- at least 4 weeks postoperative recovery

- coagulation studies w/i normal limits

- ECOG > 2

- Life expectancy of > 4 months.

- must understand and sign the study specific informed consent.

Exclusion Criteria:

- not enough lysate for vaccine preparation

- known brain metastases

- any of the following positive tests at the screening visit: (HTLV-1/2 ; Hepatitis B,
HIV, Hepatitis C, Anti-Yo(cdr2) antibody present in serum

- on corticosteroids

- prior IV Cytoxan at maximally tolerated dose

- serum creatinine > 2.2 mg/dl or BUN > 40 mg/dl

- proteinuria > 3.5gm over 24 hrs

- serum total bilirubin > 2.0 and/or serum transaminases > 3X the upper limits of

- Platelets < 100,000/ mm3 ; WBC < 3,000/mm3 ; Absolute Neutrophil Count (ANC) <
1,500/mm3 ; Absolute lymphocyte count < 1000/ mm3 ; Hematocrit < 30%

- acute infection that requires specific therapy

- serious, non-healing wound, ulcer, or bone fracture

- active bleeding or pathologic conditions that carry high risk of bleeding, such as
known bleeding disorder, coagulopathy, or tumor involving major vessels.

- history or evidence upon physical examination of CNS disease, including primary brain
tumor, seizures not controlled with standard medical therapy, any brain metastases,
or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA)
or subarachnoid hemorrhage within 6 months of the first date of treatment on this

- clinically significant cardiovascular disease; this includes: (Uncontrolled
hypertension ; Myocardial infarction or unstable angina within 6 months prior to
registration ; New York Heart Association (NYHA) Grade II or greater congestive heart
failure ; Serious cardiac arrhythmia requiring medication ; Grade II or greater
peripheral vascular disease.

- clinically significant peripheral artery disease, e.g., those with claudication,
within 6 months.

- clinical symptoms or signs of partial or complete gastrointestinal obstruction or who
require parenteral hydration and/or nutrition.

- any underlying conditions which would contraindicate therapy with study treatment (or
allergies to reagents used in this study). Subjects with known hypersensitivity to
Chinese hamster ovary cell products or other recombinant human or humanized

- organ allografts.

- known autoimmune/collagen vascular disorder.

- on any medications that might affect immune function. Additionally, H2 antagonists
are excluded as are all antihistamines five days before and five days after each
injection of study drug. NSAIDS including COX-2 inhibitors, acetaminophen or aspirin
are exceptions.

- pregnant or lactating.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the feasibility and safety of administering DCVax-L intradermally combined with intravenous bevacizumab and oral metronomic cyclophosphamide in patients with recurrent ovarian or primary peritoneal cancer.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

George Coukos, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania


United States: Food and Drug Administration

Study ID:

UPCC 11807



Start Date:

November 2007

Completion Date:

December 2009

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Vaccine
  • Ovarian
  • Peritoneal
  • Ovarian Neoplasms
  • Peritoneal Neoplasms



University of Pennsylvania Philadelphia, Pennsylvania  19104