Status:
COMPLETED
Phase 1 Study of NY-ESO-1 Overlapping Peptides in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This was a Phase 1, open-label study of repeated vaccination with NY-ESO-1 overlapping peptides (OLP4) with or without the immunoadjuvants Montanide and polyinosinic-polycytidylic acid - poly-L-lysine...
Detailed Description
Subjects received NY-ESO-1 OLP4 by subcutaneous injection once every 3 weeks (Weeks 1, 4, 7, 10, and 13) for a total of 5 vaccinations. Subjects were assigned sequentially to 1 of 3 dosing cohorts: ...
Eligibility Criteria
Inclusion
- Histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, stage II to IV at diagnosis, and post-initial cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen.
- In second or third stable complete clinical remission, defined as a) stable cancer antigen (CA)-125 \< 35 U/ml (defined as CA-125 that had not doubled from the post chemotherapy nadir), b) unremarkable physical examination, and c) no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm that are often present in the pelvis were not considered definite evidence of disease.
- Expected survival of at least 4 months.
- Karnofsky performance scale ≥ 70%.
- Laboratory values within the following limits:
- Hemoglobin ≥ 10.0 g/dL
- Neutrophil count ≥ 1.5 x 10\^9/L
- Platelet count ≥ 80 x 10\^9/L
- Serum creatinine ≤ 2.0 mg/dL
- Serum bilirubin ≤ 2.5 x institutional upper limit of normal (ULN)
- aspartate aminotransferase/alanine aminotransferase ≤ 2.5 x institutional ULN
- Age ≥ 18 years.
- ≥ 4 weeks since completion of prior cytotoxic chemotherapy.
- Able and willing to give valid written informed consent
Exclusion
- Clinically significant heart disease (New York Heart Association Class III or IV).
- Serious intercurrent illness, eg, serious infections requiring prolonged parenteral antibiotics or bleeding disorders requiring hospitalization.
- Positive stool guaiac excluding hemorrhoids.
- Known autoimmune disease (ie, rheumatoid arthritis, ulcerative colitis, etc); or immune deficiency (human immunodeficiency virus, hypogammaglobulinemia); or known active infections with Hepatitis B or Hepatitis C; or receipt of immunosuppressive drugs such as systemic corticosteroids or cyclosporin, etc.
- Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
- History of previous severe allergic reactions to vaccines or unknown allergens.
- Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.
- Lack of availability for immunological and clinical follow-up assessments.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent.
- Pregnancy or breast-feeding.
- Women of childbearing potential: Refusal or inability to use effective means of contraception.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00616941
Start Date
March 1 2008
End Date
June 1 2011
Last Update
October 12 2022
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021