Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02364713 : MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- PRE-REGISTRATION INCLUSION CRITERIA:

- Ability to understand and the willingness to sign a written informed consent document

- Study participants will be women who have gone through a bi-lateral oophorectomy
procedure

- Willingness to be evaluated for surgical placement of an intraperitoneal port and
undergo biopsy if feasible for a research sample

- REGISTRATION/RANDOMIZATION INCLUSION CRITERIA:

- Recurrent, persistent, or progressive epithelial ovarian, fallopian tube, or primary
peritoneal cancer after treatment with bilateral oophorectomy and either cisplatin or
carboplatin and either paclitaxel, albumin-bound paclitaxel, or docetaxel; histologic
confirmation of the primary tumor is required; eligible histologies include serous,
endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed
carcinoma

- Platinum-resistant or platinum-refractory disease, defined as either 1) less than a
complete response to the most recent carboplatin- or cisplatin-containing
chemotherapy regimen, 2) serum cancer antigen (CA)-125 >= 2 x upper limit of normal
(ULN) within 180 days of last dose of carboplatin- or cisplatin-containing
chemotherapy, confirmed by a second CA-125 (the second CA-125 does not have to be
within 180 days of chemotherapy), or 3) CT or positron emission tomography (PET)/CT
evidence of cancer recurrence within 180 days of last dose of carboplatin- or
cisplatin-containing chemotherapy

- Absolute neutrophil count (ANC) >= 1500/uL

- Platelet (PLT) >= 100,000/uL

- Total bilirubin =< ULN

- Aspartate aminotransferase (AST) =< 2 x ULN

- Creatinine =< 1.5 x ULN

- Hemoglobin (Hgb) >= 9.0 g/dL

- Willingness to return to Mayo Clinic Rochester or another participating institution
for follow-up; patients who are randomized to Arm B (cytotoxic chemotherapy) may
receive chemotherapy at any oncology clinic able to provide the protocol-directed
therapy and willing to send laboratory data to the participating institution;
however, patients must be willing to return to the participating institution every
two months for evaluation; patients who are randomized to Arm A must be willing to
receive all treatment and follow-up at a participating institution

- Life expectancy >= 12 weeks

- Willingness to provide all biologic specimens as required by the protocol

- Measurable disease by physical exam or CT scan, or evaluable disease by CA-125;
(NOTE: CA-125-evaluable disease is defined as serum CA-125 >= 2 x ULN that is
determined by the treating clinician to be due to recurrent ovarian, fallopian tube,
or primary peritoneal cancer)

- Normal cardiac function, as determined by left ventricular ejection fraction (LVEF)
>= institutional lower limit of normal on echocardiogram or multi-gated acquisition
scan (MUGA) within 1 month of registration

- If liposomal doxorubicin hydrochloride (DOXIL) is selected as the investigator's
choice chemotherapy:

- Lifetime exposure to doxorubicin =< 240 mg/m^2 (or equivalent biologic dose if
prior exposure to a different anthracycline)

- Candidate for surgical placement of an intraperitoneal port, as determined by a
gynecologic oncology surgeon

- Must have anti-measles immunity as demonstrated by serum immunoglobulin (Ig)G
anti-measles antibody levels of >= 1.1 EU/ml as determined by BioPlex Measles IgG
multiplex flow immunoassay

Exclusion Criteria:

- REGISTRATION/RANDOMIZATION EXCLUSION CRITERIA:

- Epithelial tumors of low malignant potential, stromal tumors, and germ cell tumors of
the ovary

- Evidence of cancer outside of the peritoneal cavity (ex: mediastinal lymphadenopathy,
parenchymal liver metastasis, or pleural effusion proven or suspected to be due to
cancer)

- Bulky metastases, defined as any tumor nodule or lymph nodes > 2 cm in greatest
dimension on axial images on pre-treatment CT, PET/CT, or magnetic resonance imaging
(MRI)

- Note: patients with bulky (> 2 cm) disease for whom gross total cytoreduction is
deemed feasible by a surgeon (with confirmation by a second surgeon after
radiologic review) are eligible for participation in the context of
cytoreductive surgery

- Resistant to all of the following: DOXIL, gemcitabine hydrochloride (GEM), topotecan
hydrochloride (TOPA), and weekly paclitaxel (TAXOL); (NOTE: resistance is defined as
either 1) less than a complete response to any chemotherapy regimen containing the
agent in question [consider weekly TAXOL as a separate agent from every-three-week
TAXOL], 2) serum CA-125 >= 2 x ULN within 180 days of last dose of chemotherapy
containing the agent in question, confirmed by a second CA-125 [the second CA-125
does not have to be within 180 days of chemotherapy], or 3) CT or PET/CT evidence of
cancer recurrence/progression within 180 days of last dose of chemotherapy containing
the agent in question; [for example, if a patient previously received carboplatin and
GEM, had a complete response, and had initial evidence of relapse > 180 days after
the last dose of GEM, that patient would not be considered resistant to GEM])

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 3 or 4

- History of other malignancy =< 5 years prior to registration except for non-melanoma
skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS)

- Active infection =< 7 days prior to study entry

- Any of the following prior therapies:

- Chemotherapy =< 3 weeks prior to study entry

- Immunotherapy =< 4 weeks prior to study entry

- Biologic therapy =< 4 weeks prior to study entry

- Extensive abdominal surgery if it includes enterotomy(ies) =< 3 weeks prior to
study entry; (NOTE: this criterion does not apply to placement of the peritoneal
Port-A-Cath or lysis of adhesions at the time of study entry)

- Any viral or gene therapy prior to study entry

- Failure to recover to =< grade 1 from acute, reversible effects of prior
chemotherapy, excluding alopecia regardless of interval since last treatment (NOTE:
patients with residual peripheral neuropathy are allowed)

- New York Heart Association classification III or IV congestive heart failure, known
symptomatic coronary artery disease, symptoms of coronary artery disease on systems
review, or known cardiac arrhythmias (atrial fibrillation or supraventricular
tachycardia [SVT])

- Other cardiac or pulmonary disease that, at the investigator's discretion, can impair
treatment safety

- Central nervous system (CNS) metastases or seizure disorder

- Human immunodeficiency virus (HIV)-positive test result, or history of other
immunodeficiency

- History of organ transplantation

- History of chronic hepatitis B or C

- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
considered investigational (utilized for a non-Food and Drug Administration
[FDA]-approved indication and in the context of a research investigation)

- Any concurrent medications which could interfere with the trial

- History of tuberculosis or history of purified protein derivative (PPD) positivity

- Treatment with oral/systemic corticosteroids, with the exception of topical or
inhaled steroids or steroids given for the purpose of adrenal replacement given at
physiologic doses

- Exposure to household contacts =< 15 months old or household contact with known
immunodeficiency

- Allergy to measles vaccine or history of severe reaction to prior measles vaccination

- Allergy to iodine; (NOTE: this does not include reactions to intravenous contrast
materials)

- Any other pathology or condition which the principal investigator may deem to
negatively impact treatment safety

- On anticoagulation and unable to discontinue temporarily
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02364713      |      Link to official Clinicaltrials.gov listing
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