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| Sponsor: | Roswell Park Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00803569 |
Purpose
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with stage II, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Biological: ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine Biological: sargramostim |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label |
| Official Title: | Phase I Study of ALVAC(2)-NY-ESO-1(M)/TRICOM in Patients With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen |
| Estimated Enrollment: | 12 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine subcutaneously (SC) on day 1 and sargramostim (GM-CSF) SC on days 1-4. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
Tumor expresses 1 of the following antigens:
Must have demonstrated complete response to prior front-line therapy as evidenced by negative clinical examination, no objective evidence of disease progression by CT scan, and serum CA-125 ≤ 35 IU/mL
Recurrent disease allowed provided patient completed surgery and/or chemotherapy for recurrent disease
PATIENT CHARACTERISTICS:
None of the following cardiovascular conditions:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior and no concurrent chemotherapy (6 weeks for nitrosoureas), radiotherapy, immunotherapy, or other anticancer therapy
No concurrent systemic corticosteroids, antihistamines, non-steroidal anti-inflammatory drugs, or other immunosuppressants
Contacts and Locations| United States, New York | |
| NYU Cancer Institute at New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Nina Bhardwaj, MD 212-263-6485 | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
| Study Chair: | Adekunle O. Odunsi, MD, PhD | Roswell Park Cancer Institute |
More Information
| Responsible Party: | Roswell Park Cancer Institute ( Adekunle Omotayo Odunsi ) |
| Study ID Numbers: | CDR0000628730, RPCI-I-125207, LUDWIG-LUD2007-005 |
| Study First Received: | December 4, 2008 |
| Last Updated: | December 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00803569 History of Changes |
| Health Authority: | Unspecified |
|
recurrent ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer |
stage IV ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
|
Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms Fallopian Tube Neoplasms |
Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |