Clinical trial NCT01248273: Unimolecular Pentavalent (Globo-H-GM2-sTn-TF-Tn) Immunization of Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer in First Remission
Official title: Phase I Trial of Unimolecular Pentavalent (Globo-H-GM2-sTn-TF-Tn) Immunization of Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer in First Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fallopian Tubes
Ovarian Cancer
Peritoneal Cancer
Keywords: GLOBO H-KLH CONJUGATE
MUC-1 KLH
QS-21
TF(C)-KLH
TN(C)-KLH
Immunization
Vaccine
09-184
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 26
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to 1) test the safety of the vaccine to find out what effects, good and/or bad, it has, and 2) to find out if the vaccine stimulates the immune system. The vaccine in this study will contain several parts. The first part is called an antigen. These antigens or "fingerprints" are found on many cancer cells, especially from the ovaries, fallopian tubes, or peritoneal cavity (inside lining of the abdomen) The purpose of this study is to see if investigators can help the immune system to recognize that cancer cells are not normal and should be removed.


Eligibility criteria: Inclusion Criteria:

* Any histologically documented stage III or IV epithelial carcinoma arising in the ovary, fallopian tube or peritoneum.
* History of cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment.
* Patients must be in a first complete clinical remission. Complete clinical remission is defined as serum CA-125 within institutional normal limits, negative physical examination, and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0cm are often present in the pelvis and will not be considered definite evidence of disease. Eligibility is determined by anatomical imaging only (ie. MRI or CT). Positive PET image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative.
* Adequate organ function defined by
* Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,000/mm³, grade 1. Platelets greater than or equal to 100,000/mm³.
* Renal function: Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1.
* Hepatic function: Bilirubin, SGOT, and alkaline phosphatase less than or equal to 2.5 x ULN
* Negative stool hemoccult (or negative endoscopic evaluation if positive). External hemorrhoids are a common source of a positive hemoccult and should not exclude patients.
* TSH not elevated above normal range
* KPS \> or = to 80%.
* Patients have signed the informed consent document and signed the authorization permitting release of personal health information.
* Age \> 18 years
* Patients must have recovered from clinically significant side effects from prior chemotherapy

Exclusion Criteria:

* Pregnant or nursing women
* Patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years, or whose previous cancer treatment contraindicated this protocol therapy are excluded. Non-melanoma skin cancers are an exception and will not exclude any patient.
* Patients with a history of a seafood allergy.
* Patients who have previously received a vaccine with any of the antigens in the current trial.
* Patients with a history of immunodeficiency or autoimmune disease (excluding treated hypothyroidism).
* Patients with active CNS tumor.

Primary outcomes:
measure: To determine immunologic response
timeFrame: 6 months
measure: To determine the toxicities following immunization with this unimolecular polyvalent vaccine.
timeFrame: 2 years
measure: To determine the maximum tolerated dose over three dose levels.
timeFrame: 2 years
Secondary outcomes:
measure: To record the progression free interval
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Paul Sabbatini, MD
role: PRINCIPAL_INVESTIGATOR
References: