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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02482090 |
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Date of registration:
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23/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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TIL Therapy for Metastatic Ovarian Cancer
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Scientific title:
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T Cell Therapy for Patients With Metastatic Ovarian Cancer |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02482090 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Inge Marie Svane, Prof., MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Center for Cancer Immune Therapy, Dept of Hematology/Oncology, Copenhagen University Hospital Herlev, Herlev Ringvej 75, DK-2730 |
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Name:
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Magnus Pedersen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Center for Cancer Immune Therapy, Dept of Hematology/Oncology, Copenhagen University Hospital Herlev, Herlev Ringvej 75, DK-2730 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically confirmed high grade serous adenokarcinoma ovarian cancer metastasis
available for surgical resection (more than 1 cm3) and residual measurable disease
after resection
- Progression/reccurence of ovarian cancer after 1. line platin based chemotherapy or
progression/reccurence after 2. line or additional chemotherapy
- ECOG performance status 0-1
- Life expectancy > 6 months
- No significant toxicity from prior treatments, except sensoric- and motoric
neuropathia and/or alopecia
- Adequate renal, hepatic and hematological function
- Women of childbearing potentil (WOCBP) must be using an effective method of
contraception during treatment and for at least 6 months after completion of treatment
- Able to comprehend the information given and willing to sign informed consent
Exclusion Criteria:
- Other malignancies, unless followed for = 5 years with no sign of disease
- Severe allergies, history of anaphylaxis or known allergies to the administered drugs.
- Serious medical or psychiatric comorbidity
- Creatinine clearance < 70 ml/min
- Acute or chronic infection with e.g. HIV, hepatitis, tuberculosis
- Severe and active autoimmune disease
- Pregnant and nursing women
- Need for immunosuppressive treatment, e.g. corticosteroids or methotrexate
- Concomitant treatment with other experimental drugs
- Patients with uncontrolled hypercalcemia
- Less than four weeks since prior systemic antineoplastic treatment at the time of
treatment
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Metastatic Ovarian Cancer
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Intervention(s)
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Biological: TIL infusion
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Drug: Cyclophosphamide
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Drug: Fludarabine
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Drug: Interleukin-2
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Primary Outcome(s)
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Number and type of reported adverse events
[Time Frame: 0-24 weeks]
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Secondary Outcome(s)
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Progression free survival
[Time Frame: Up to 12 months]
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Treatment related immune responses
[Time Frame: Up to 12 months]
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Objective response rate
[Time Frame: Up to 12 months]
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Overall Survival
[Time Frame: Up to 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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