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Phase 1 N=9 Treatment

Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Fallopian Tube Cancer · Ovarian Cancer · Primary Peritoneal Cavity Cancer

Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Number of Patients With Dose Limiting Toxicities (DLTs) — 0 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
NY-ESO-1 peptide vaccine (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Ludwig Institute for Cancer Research
Primary completion
May 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Dose Limiting Toxicities (DLTs)
SECONDARY
Number of Patients Developing NY-ESO-1 Antibodies After Treatment
2; 7
SECONDARY
Number of Patients With NY-ESO-1b-Specific CD8+ T Cells Measured by Tetramer Analysis
3; 1; 3; 2
SECONDARY
Number of Patients With NY-ESO-1b-Specific Activated CD8+ T Cells Measured by ELISPOT
3; 1; 3; 2
SECONDARY
Number of Patients With NY-ESO-1b-specific Delayed-type Hypersensitivity (DTH)
0; 9

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: A phase I trial to study the side effects of vaccine therapy in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Eligibility Criteria

Inclusion Criteria

  • Histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, from Stage II-IV at diagnosis, receiving initial cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen.
  • High risk feature defined as suboptimal primary debulking (remaining tumor masses with diameter ≥ 1.0 cm) or failure to normalize CA125 during primary therapy by the end of the third cycle or positive second-look surgery.
  • Patients must be in complete clinical remission defined as CA125 < 35 units, 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 ≤ 1.0 cm that are often present in the pelvis may not be considered definite evidence of disease.
  • Expected survival of at least 6 months.
  • Karnofsky performance scale ≥60%.
  • Within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified:
  • Absolute neutrophil count (ANC) ≥1000/mm^3
  • Platelets ≥ 80,000/mm^3
  • Creatinine ≤ 1.5mg/dL
  • Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and total bilirubin all < 2.5 x upper limit of normal (ULN) 7 Age ≥ 18 years.
  • Able and willing to give valid written informed consent. 9. HLA A02 positive. Exclusion Criteria

Patients were excluded from the study for any of the following reasons:

  • Clinically significant heart disease (NYHA Class III or IV).
  • Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders.
  • Patients with serious intercurrent illness, requiring hospitalization.
  • Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
  • Patients taking immunosuppressive drugs such as systemic corticosteroids or non-steroidal anti-inflammatory drugs.
  • Known HIV positivity.
  • Other malignancy within 3 years prior to entry into the study, except for treated nonmelanoma skin cancer and cervical carcinoma in situ.
  • Mental impairment that may compromise 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 enrollment.
  • Pregnancy or breastfeeding.
  • Women of childbearing potential: Refusal or inability to use effective means of contraception.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00066729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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