Recurrent Ovarian Epithelial Cancer Clinical Trial
Official title:
A Phase I Clinical Trial of NY-ESO-1 Protein Immunization in Combination With 5-AZA-2'-Deoxycytidine (Decitabine) in Patients Receiving Liposomal Doxorubicin for Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Verified date | July 2022 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I trial is studying the side effects and best dose of decitabine when given together with pegylated liposomal doxorubicin hydrochloride and vaccine therapy in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer. Drugs used in chemotherapy, such as decitabine and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with vaccine therapy may kill more tumor cells
Status | Completed |
Enrollment | 18 |
Est. completion date | June 2013 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects with relapsed epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) who will receive liposomal doxorubicin as salvage therapy for recurrent disease - Patients may have received up to four previous lines of chemotherapy - The relapse may be defined by an increase in CA125; there may or may not be either measurable or symptomatic disease - Any human leukocyte antigen (HLA) type - No requirement for tumor expression of NY-ESO-1 - Karnofsky performance status of > 70% - Not previously treated with doxorubicin - Life expectancy >= 6 months - Hematology and biochemistry laboratory results within the limits normally expected for the patient population, without evidence of major organ failure - No immunodeficiency - Have been informed of other treatment options - Able and willing to give valid written informed consent - Neutrophil count >= 1.5 x 10^9 - Platelet count >= 100 x 10^9 - Serum creatinine =< 2.1 mg/dL - Serum bilirubin =< 2 mg/dL - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.6 x upper limit of normal (ULN) (normal ranges: AST 15-46 U/L; ALT 11-66 U/L) Exclusion Criteria: - Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available - Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders) - History of autoimmune disease (e.g., thyroiditis, lupus) except vitiligo - Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs; specific CQX-2 inhibitors are permitted - Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing of study agent (6 weeks for nitrosoureas) - Known human immunodeficiency virus (HIV) positivity - Known allergy or history of life threatening reaction to GM-CSF - Myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, chest pain or shortness of breath with activity, or other heart conditions being treated by a doctor - Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent - Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study - Lack of availability of a patient for immunological and clinical follow-up assessment |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute | Eisai Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | Estimated with a one-sided, 95%, Wilson score binomial confidence interval. | Up to 6 months | |
Secondary | NY-ESO-1 specific cellular and humoral immunity as assessed by NY-ESO-1-specific CD8+ and CD4+ T cells and antibodies and frequency of CD4+ CD25+ FOXP3+ regulatory T cells | Will be summarized by quartiles. Also, confidence intervals will be constructed for the median and the mean. | Up to 6 months | |
Secondary | NY-ESO-l expression using Q-RT-PCR and IHC | Days 1, 8, 15, 36, 43, 64, 71, 92, and 99 | ||
Secondary | Time to progression | Summarized by a Kaplan-Meier survival curve. | Up to 6 months | |
Secondary | NY-ESO-l promoter DNA methylation using pyrosequencing | Days 1, 8, 15, 36, 43, 64, 71, 92, and 99 | ||
Secondary | Global genomic DNA methylation using liquid chromatography-mass spectrometry (LC-MS) and LINE-l pyrosequencing | Days 1, 8, 15, 36, 43, 64, 71, 92, and 99 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00390234 -
Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma
|
Phase 2 | |
Completed |
NCT00096395 -
Sorafenib Tosylate and Gemcitabine Hydrochloride in Treating Patients With Recurrent Epithelial Ovarian Cancer
|
Phase 2 | |
Terminated |
NCT00091195 -
Depsipeptide (Romidepsin) in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer
|
Phase 2 | |
Completed |
NCT00026091 -
Fenretinide in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
|
Phase 2 | |
Terminated |
NCT01962948 -
Paclitaxel and Ganetespib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01764789 -
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
|
N/A | |
Completed |
NCT00093496 -
Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer
|
Phase 2 | |
Completed |
NCT00275028 -
AZD2171 in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
|
Phase 2 | |
Completed |
NCT00132067 -
Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
|
Phase 2 | |
Completed |
NCT00006942 -
Bryostatin 1 and Cisplatin in Treating Patients With Advanced Recurrent or Residual Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 2 | |
Completed |
NCT00004032 -
Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
|
Phase 1 | |
Completed |
NCT00023712 -
Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
|
Phase 2 | |
Terminated |
NCT01249443 -
Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection
|
Phase 1 | |
Completed |
NCT02046421 -
Carboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1 | |
Completed |
NCT00028535 -
Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors
|
Phase 1 | |
Completed |
NCT01747798 -
Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
|
Early Phase 1 | |
Completed |
NCT01652794 -
Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer
|
Phase 1 | |
Withdrawn |
NCT01558778 -
Mechanical Stimulation in Preventing Bone Density Loss in Patients Undergoing Donor Stem Cell Transplant
|
N/A |