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Determine if Either of 2 Doses of Study Drug Given With a Low-dose of Cyclophosphamide After a Complete or Partial Response to a Platinum-based Second-line Therapy in Women With Recurrent Ovarian Carcinoma Results in a Longer Time to Progression When Compared to the First Time to Progression.

Primary Purpose

Ovarian Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tucotuzumab celmoleukin (EMD 273066)
Sponsored by
EMD Serono
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian, Cancer, Epithelial, Recurrent, Platinum, Second-line therapy, Maintenance Therapy, Biologic, Targeted Therapy, Antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed written informed consent
  • Age 18 years or older
  • Have histologically documented ovarian carcinoma (including primary peritoneal carcinoma)
  • Have archival tumor tissue available for EpCAM expression determination by immunohistochemistry
  • Received first-line platinum-based chemotherapy of up to 8 cycles (approximately 15 to 24 weeks)
  • Experienced a complete response to first-line platinum-based chemotherapy
  • Experienced a platinum-free interval of at least 6 but not more than 24 months starting at the end of the last cycle of first-line chemotherapy until recurrence

    • Treatment with Avastin (bevacizumab) is permitted during first-line platinum-based chemotherapy through TTP and platinum-based reinduction therapy up to 28 days prior to start of EMD 273066
  • Experienced a partial or complete response after up to 8 cycles of second-line platinum-based chemotherapy
  • Have a CT/MRI scan within 4 weeks prior to starting treatment
  • Be able to start cyclophosphamide and EMD 273066 treatment within 3 to 5 weeks of completion of second-line chemotherapy
  • KPS ≥70%
  • No clinical history of significantly impaired renal function or chronic kidney disease. Must have an estimated glomerular filtration rate ≥50 mL/min determined by the Cockgroft-Gault-formula
  • WBC count ≥2.5x10³/µL (or total granulocytes ≥1x10³/µL)
  • Absolute lymphocyte count (ALC) ≥0.5x103/µL
  • Platelet count ≥100,000/µL
  • Hemoglobin (Hgb) level ≥9 g/dl
  • ALT and AST ≤2.5xULN, total bilirubin <1.5xULN
  • Serum sodium, potassium and phosphorus within normal limits
  • Serum amylase within normal limits
  • Serologic testing within 4 weeks prior to starting study treatment with negative results for hepatitis C virus (HCV), human immunodeficiency virus (HIV) and hepatitis B virus (HBV) demonstrated by negative hepatitis B core antibody (HBc Ab) and hepatitis B surface antigen (HbsAg)
  • Negative pregnancy test and willingness to use effective contraception for the study duration and 1 month thereafter if of procreative potential

Exclusion Criteria:

  • Dyspnea at rest, exercise intolerance
  • In any subject with clinically significant non-malignant pulmonary disease: Pulmonary function testing (to include Forced Vital Capacity [FVC] and 1-second Forced Expiratory Volume [FEV-1]) showing <70% of predicted values for FVC or FEV-1 and/or DLCO <50%.
  • In any subject with pulmonary or pleural metastatic disease: Arterial oxygen saturation at rest measured transcutaneously on room air < 90% or increased risk for respiratory compromise related to IL2 exposure in the judgment of the investigator.
  • ECG with evidence of clinically significant disease within 4 weeks prior to starting study treatment
  • Cardiac stress test (e.g., exercise or pharmacological thallium test; exercise or pharmacological echocardiography) with abnormal results within 4 weeks prior to starting treatment in subjects who have a history of coronary heart disease (myocardial infarction, angina pectoris or pathologic coronary angiography)
  • Any current evidence of congestive heart failure with NY Heart Association Grade 2 through 4 or echocardiogram with a left ventricular ejection fraction <45% or other signs of clinical significant heart disease
  • History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other clinically significant arrhythmias
  • Evidence of active brain metastases
  • Previous malignancy other than ovarian cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix
  • Pregnant or lactating female
  • An immediate need for palliative radiotherapy or systemic corticosteroid therapy
  • Significant active infection
  • Major surgery, chemotherapy, or radiation within 21 days of starting study treatment
  • Received another experimental drug within 28 days of starting study treatment
  • Uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg) or hypotension (systolic ≤90 mmHg)
  • Presence of medically significant third space fluids such as pleural or pericardial effusions or edema of toxicity grade ≥2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 [17].

    • Exception allowed for disease-related peritoneal ascites unless patient requires frequent and repetitive paracentesis management.

Previous diagnosis of an autoimmune disease involving a major organ system

  • Transplant recipient on immunosuppressive therapy
  • Acute esophageal or gastroduodenal ulcers
  • History of prior therapy or a serious uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Tucotuzumab celmoleukin (EMD 273066)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 6, 2006
    Last Updated
    August 15, 2017
    Sponsor
    EMD Serono
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00408967
    Brief Title
    Determine if Either of 2 Doses of Study Drug Given With a Low-dose of Cyclophosphamide After a Complete or Partial Response to a Platinum-based Second-line Therapy in Women With Recurrent Ovarian Carcinoma Results in a Longer Time to Progression When Compared to the First Time to Progression.
    Official Title
    An Open-label Phase II Study of Two Dose Levels of EMD 273066 Administered With Low-dose Cyclophosphamide Following Objective Response to Second-line Chemotherapy in Women With Recurrent Ovarian Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Th trial got cancelled and no subjects signed informed consent form (ICF); study design not appropriate any longer.
    Study Start Date
    December 31, 2006 (Actual)
    Primary Completion Date
    May 31, 2008 (Actual)
    Study Completion Date
    May 31, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EMD Serono

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if either of two doses of EMD 273066 when given with a low dose of cyclophosphamide will result in a second time to progression that is as long or longer than the first time to progression

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer
    Keywords
    Ovarian, Cancer, Epithelial, Recurrent, Platinum, Second-line therapy, Maintenance Therapy, Biologic, Targeted Therapy, Antibody

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tucotuzumab celmoleukin (EMD 273066)
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Tucotuzumab celmoleukin (EMD 273066)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed written informed consent Age 18 years or older Have histologically documented ovarian carcinoma (including primary peritoneal carcinoma) Have archival tumor tissue available for EpCAM expression determination by immunohistochemistry Received first-line platinum-based chemotherapy of up to 8 cycles (approximately 15 to 24 weeks) Experienced a complete response to first-line platinum-based chemotherapy Experienced a platinum-free interval of at least 6 but not more than 24 months starting at the end of the last cycle of first-line chemotherapy until recurrence Treatment with Avastin (bevacizumab) is permitted during first-line platinum-based chemotherapy through TTP and platinum-based reinduction therapy up to 28 days prior to start of EMD 273066 Experienced a partial or complete response after up to 8 cycles of second-line platinum-based chemotherapy Have a CT/MRI scan within 4 weeks prior to starting treatment Be able to start cyclophosphamide and EMD 273066 treatment within 3 to 5 weeks of completion of second-line chemotherapy KPS ≥70% No clinical history of significantly impaired renal function or chronic kidney disease. Must have an estimated glomerular filtration rate ≥50 mL/min determined by the Cockgroft-Gault-formula WBC count ≥2.5x10³/µL (or total granulocytes ≥1x10³/µL) Absolute lymphocyte count (ALC) ≥0.5x103/µL Platelet count ≥100,000/µL Hemoglobin (Hgb) level ≥9 g/dl ALT and AST ≤2.5xULN, total bilirubin <1.5xULN Serum sodium, potassium and phosphorus within normal limits Serum amylase within normal limits Serologic testing within 4 weeks prior to starting study treatment with negative results for hepatitis C virus (HCV), human immunodeficiency virus (HIV) and hepatitis B virus (HBV) demonstrated by negative hepatitis B core antibody (HBc Ab) and hepatitis B surface antigen (HbsAg) Negative pregnancy test and willingness to use effective contraception for the study duration and 1 month thereafter if of procreative potential Exclusion Criteria: Dyspnea at rest, exercise intolerance In any subject with clinically significant non-malignant pulmonary disease: Pulmonary function testing (to include Forced Vital Capacity [FVC] and 1-second Forced Expiratory Volume [FEV-1]) showing <70% of predicted values for FVC or FEV-1 and/or DLCO <50%. In any subject with pulmonary or pleural metastatic disease: Arterial oxygen saturation at rest measured transcutaneously on room air < 90% or increased risk for respiratory compromise related to IL2 exposure in the judgment of the investigator. ECG with evidence of clinically significant disease within 4 weeks prior to starting study treatment Cardiac stress test (e.g., exercise or pharmacological thallium test; exercise or pharmacological echocardiography) with abnormal results within 4 weeks prior to starting treatment in subjects who have a history of coronary heart disease (myocardial infarction, angina pectoris or pathologic coronary angiography) Any current evidence of congestive heart failure with NY Heart Association Grade 2 through 4 or echocardiogram with a left ventricular ejection fraction <45% or other signs of clinical significant heart disease History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other clinically significant arrhythmias Evidence of active brain metastases Previous malignancy other than ovarian cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix Pregnant or lactating female An immediate need for palliative radiotherapy or systemic corticosteroid therapy Significant active infection Major surgery, chemotherapy, or radiation within 21 days of starting study treatment Received another experimental drug within 28 days of starting study treatment Uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg) or hypotension (systolic ≤90 mmHg) Presence of medically significant third space fluids such as pleural or pericardial effusions or edema of toxicity grade ≥2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 [17]. Exception allowed for disease-related peritoneal ascites unless patient requires frequent and repetitive paracentesis management. Previous diagnosis of an autoimmune disease involving a major organ system Transplant recipient on immunosuppressive therapy Acute esophageal or gastroduodenal ulcers History of prior therapy or a serious uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Responsible
    Organizational Affiliation
    Merck KGaA, Darmstadt, Germany
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Determine if Either of 2 Doses of Study Drug Given With a Low-dose of Cyclophosphamide After a Complete or Partial Response to a Platinum-based Second-line Therapy in Women With Recurrent Ovarian Carcinoma Results in a Longer Time to Progression When Compared to the First Time to Progression.

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