GOG-0255: Fast Fact Sheet for Protocol 0255 (Ovary) NCT00857545 OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission Source Form: NCI FormBuilder:

  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 7/3/15 7/3/15 -
  5. 9/20/21 9/20/21 -
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September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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GOG-0255: Fast Fact Sheet for Protocol 0255 (Ovary) NCT00857545

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  1. StudyEvent: GOG-0255: Fast Fact Sheet for Protocol 0255 (Ovary)
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Patient demographics
Method of Payment
Miscellaneous Patient Information
Did the patient sign an approved informed consent
Has HIPAA authorization been obtained
Is the disease recurrent or persistent
What is the site of the disease
Was the primary disease documented histologically
Has the patient had initial cytoreductive surgery
Has the patient had at least one platinum-based chemotherapy regimen as part of the primary treatment
Has the patient had recurrent disease at least once during or after initial therapy
Is the patient now in clinical remission, including having normal CA-125 values, a negative physical exam, and no evidence of definitive disease by CT of the abdomen and pelvis
Is the patient within four months of their last treatment
What was the grade of the primary tumor
What is the cell type
Is the patient of childbearing potential
If the patient is of childbearing potential, has she had a negative serum pregancy test and been practicing an effective form of contraception
Is patient currently breastfeeding
Has the patient met the pre-entry requirements as specified in section 7.0
Will the patient have a history and physical exam and radiographic disease assessment within 28 days prior to initiating protocol therapy
Will the patient have the following paramenters measured within 14 days prior to initiating protocol therapy (Toxicity Assessment, CBC, Differential, Hepatic Profile, Creatinine, Amylase, Urinalysis, Prothrombin Time, TSH, Serum CA-125 and ANC)
Does the patient have any invasive malignancies (other than non-melanoma skin cancer) that have shown any evidence of the other cancer present within the last five years
Is the patient at least 18 years of age as of this date
Has the patient had previous cancer treatment which contraindicates this protocol therapy
Does the patient have an allergy to shellfish
Are there circumstances that will not permit completion of study therapy or the required follow-up
Lab Results
Is the creatinine less than or equal to 1.5 X ULN
Is the bilirubin less than or equal to 2.5 X ULN
Are the SGOT and SGPT less than or equal to 2.5 x ULN
Is the alkaline phosphatase less than or equal to 2.5 X ULN
Performance Status

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