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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091000 |
RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with sargramostim works in treating patients with metastatic cancer .
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Colorectal Cancer Ovarian Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: falimarev Drug: inalimarev Drug: sargramostim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | An Open Label Pilot Study to Evaluate the Safety and Tolerability of PANVAC-V (Vaccinia) and PANVAC-F (Fowlpox) in Combination With Sargramostim in Adults With Metastatic Carcinoma |
Estimated Enrollment: | 51 |
Study Start Date: | July 2004 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, open-label, pilot study. Patients are stratified according to disease type (colorectal carcinoma vs noncolorectal* carcinoma vs breast carcinoma vs ovarian carcinoma).
NOTE: *No longer accruing patients other than those with breast cancer as of 11/1/2007.
Patients are followed every 4 weeks for 3 months and then annually for up to 15 years.
PROJECTED ACCRUAL: Approximately 51 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal*, noncolorectal*, ovarian, or breast carcinoma
HLA-A2 positive (for patients with colorectal carcinoma*)
Completed ≥ 1 fluorouracil-containing chemotherapy regimen (e.g., fluorouracil and leucovorin calcium with or without either irinotecan or oxaliplatin) for colorectal carcinoma*
Hormone receptor status
PATIENT CHARACTERISTICS:
Age
Menopausal status
Sex
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No altered immune function, including any of the following conditions:
Gastrointestinal
Other
No close household contact (sharing housing or having close physical contact) with the following individuals for 3 weeks after each vaccination:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent systemic steroids except physiologic doses for systemic steroid replacement OR local (topical, nasal, or inhaled) steroid use
No concurrent anticancer hormonal therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
National Naval Medical Center | |
Bethesda, Maryland, United States, 20892-9255 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | James Gulley, MD, PhD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000381300, NCI-04-C-0246, NCI-6536 |
Study First Received: | September 7, 2004 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00091000 |
Health Authority: | United States: Food and Drug Administration |
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer unspecified adult solid tumor, protocol specific recurrent breast cancer |
stage IV breast cancer recurrent ovarian epithelial cancer recurrent ovarian germ cell tumor stage IV ovarian epithelial cancer stage IV ovarian germ cell tumor male breast cancer |
Gonadal Disorders Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Rectal Diseases Genital Diseases, Female Neoplasm Metastasis Rectal cancer Breast Diseases Endocrine Gland Neoplasms Ovarian cancer Ovarian Neoplasms |
Digestive System Neoplasms Skin Diseases Vaccinia Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Intestinal Diseases Intestinal Neoplasms Recurrence Rectal neoplasm Carcinoma Digestive System Diseases Breast Neoplasms, Male Gastrointestinal Neoplasms Endocrinopathy |
Neoplasms Neoplasms by Site Adnexal Diseases |