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A Phase I, Open, Randomized, Study to Investigate the Safety of Active Immunotherapy With Fully Mature, TERT-mRNA and Survivin - Peptide Double Loaded Dendritic Cells (DCs) in Subjects With Advanced Epithelial Ovarian Cancer, Enrolled in the Study Within Twelve Weeks After Completing Primary Therapy


Phase 1
18 Years
75 Years
Open (Enrolling)
Female
Ovarian Epithelial Cancer

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Trial Information

A Phase I, Open, Randomized, Study to Investigate the Safety of Active Immunotherapy With Fully Mature, TERT-mRNA and Survivin - Peptide Double Loaded Dendritic Cells (DCs) in Subjects With Advanced Epithelial Ovarian Cancer, Enrolled in the Study Within Twelve Weeks After Completing Primary Therapy


This is an uncontrolled, randomized, parallel-group, open-label phase I trial in patients
with advanced epithelial ovarian cancer. Patients were randomized into treatment group A
with weekly administration versus treatment group B with bi-weekly administration.

Patients in both treatment groups received a maximum of eight injections administered one by
one once a week for eight times for treatment group A and once in a fortnight for eight
times for treatment group B.

The treatment was completed within seven weeks for Arm A and within 14 weeks for Arm B.
Independently of the treatment arm they had been assigned to, all the patients were followed
for a period covering a total of 12 or 19 weeks or until disease progression. Safety
parameters (primary objective) and efficacy parameters (secondary objective) were recorded.
Upon completion of the treatment, one follow-up visit took place at week 12 (group A, only)
or 19 (group B, only).

To protect the patients' safety, the first six patients were treated as described below:

- The first patient was hospitalized and kept under medical observation for 72h after
administration of the first and second dose of the investigational product;

- After an observational period of 3 days following the second dose of the first patient,
the second and the third patient were administered the first dose of the
investigational product, hospitalized and kept under medical observation for 72h. The
two patients were treated simultaneously or consecutively;

- After an observational period of 3 days after the second dose to the first three
patients, an interim safety report was sent to the Ethics Committee;

- Additionally the next three patients were hospitalized, administered their first dose
of the vaccine and kept under medical observation for 72h. The three patients were
treated simultaneously or consecutively.

15 evaluable patients (which were randomized to one of the two treatment groups in
equal numbers) 5 study sites in Austria and Hungary

Inclusion Criteria


Inclusion criteria:

Patients with epithelial ovarian cancer FIGO (Fédération Internationale de Gynécologie et
d'Obstétrique) stage III in remission after treatment with surgery (hysterectomy and
ovariectomy) and after the first primary chemotherapy (standard treatment e.g. 6-9x
Carboplatin/Taxane)

- Age > 18 ≤ 75 years

- Histological confirmed FIGO stage III ovarian epithelial cancer

- Stable disease at screening visit: negative CT and CA-125 within normal range

- Karnofsky status ≥ 70% and/or ECOG (Eastern Cooperative Oncology Group) performance
status 0-2

- Life expectancy ≥ 6 months

- Adequate hematological function (WBC (white blood cells) ≥ 3000/µl, hemoglobin ≥ 10.0
g/dL, platelets > 100,000/µl)

- Adequate renal and hepatic function (serum creatinine ≤ 2.0 mg/dL, bilirubin total <
2 mg/dL, PT (INR) ≤ 1.5x institutional upper limit of normal)

- Signed and dated informed consent before the start of any study-specific procedure

- Body weight > 50 kg

Exclusion criteria:

- Surgery, radiation therapy or chemotherapy within eight weeks prior to leukapheresis

- Other biological therapy (Interferons, TNF (Tumor necrosis factors), Interleukins,
mABs (Monoclonal antibodies), biological response modifiers) within eight weeks prior
to undergo the leukapheresis

- History or presence of systemic autoimmune disease (such as, but not restricted to,
inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis,
scleroderma or multiple sclerosis)

- Participation in other clinical trials or treatments with an investigational drug
within four weeks prior to enrollment

- Serious intercurrent chronic or acute illness such as severe asthma or COPD (Chronic
Obstructive Pulmonary Disease), cardiac (NYHA (New York Heart Association ) class III
or IV) or hepatic disease, or other illness considered to constitute an unwarranted
high risk for investigational drug treatment

- History of another malignancy within five years prior to study enrollment, except
curatively treated non-melanotic skin cancer or cervical cancer in situ

- Presence of an active acute or chronic infection, including syphilis, HIV or viral
hepatitis B and/or C

- Current treatment with corticosteroids (except of local) or other immunosuppressive
agents such as azathioprine or cyclosporine A is excluded on the basis of its
potential immune suppression. Any systemic steroid therapy must have been
discontinued six weeks prior to undergo the leukapheresis

- Patients who have undergone organ transplantation

- Legally incapacitated persons and/or other circumstances, which make it difficult for
the subject to understand the nature, meaning and consequences of the clinical study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Adverse Events and clinical relevant deviations from Laboratory parameters

Outcome Time Frame:

from first treatment until up to 12 to 19 weeks

Safety Issue:

Yes

Principal Investigator

Martin Imhof, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Korneuburg

Authority:

Austria: Agency for Health and Food Safety

Study ID:

LRT-I-L01 Ovar

NCT ID:

NCT01456065

Start Date:

September 2010

Completion Date:

April 2013

Related Keywords:

  • Ovarian Epithelial Cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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