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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00055705 |
RATIONALE: PV701 may be able to kill tumor cells while leaving normal cells undamaged.
PURPOSE: Phase I trial to study the effectiveness of PV701 in treating patients who have advanced or recurrent ovarian epithelial, fallopian tube, primary peritoneal, colorectal, or other cancer found primarily within the peritoneal cavity.
Condition | Intervention | Phase |
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Cancer |
Drug: PV701 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Clinical Trial To Assess The Safety And Efficacy Of Intraperitoneal PV701 Administrations In Patients With Advanced Or Recurrent Malignancy Largely Confined To The Peritoneal Cavity |
Study Start Date: | January 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation study comprising 2 different treatment schedules.
Cohorts of 3-6 patients receive escalating doses of PV701 IV and IP until the optimal desensitization dose (ODD) is determined. The ODD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity (DLT).
Cohorts of 3-6 patients receive escalating doses of PV701 IP until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT.
PROJECTED ACCRUAL: A total of 3-50 patients will be accrued for this study within 10-17 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histological confirmation of 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Adrenal
Other
No contraindication to intraperitoneal therapy including the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | David R. Spriggs, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000270801, MSKCC-02080, NCI-1617 |
Study First Received: | March 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00055705 |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer recurrent colon cancer stage IV colon cancer ovarian sarcoma recurrent ovarian germ cell tumor stage IV ovarian germ cell tumor recurrent endometrial carcinoma stage IV endometrial carcinoma recurrent uterine sarcoma stage IV uterine sarcoma ovarian stromal cancer recurrent rectal cancer |
stage IV rectal cancer metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor gastrointestinal stromal tumor advanced malignant mesothelioma recurrent malignant mesothelioma recurrent gastric cancer stage IV gastric cancer carcinoma of the appendix small intestine adenocarcinoma small intestine leiomyosarcoma small intestine lymphoma recurrent small intestine cancer recurrent gallbladder cancer unresectable gallbladder cancer |
Leiomyosarcoma Rectal Neoplasms Malignant mesenchymal tumor Liver neoplasms Ovarian epithelial cancer Dental Caries Soft tissue sarcomas Liver Neoplasms Stomach Neoplasms Endometrial cancer Lymphoma Rectal cancer Stomach cancer Fallopian Tube Neoplasms |
Recurrence Carcinoma Rectal neoplasm Gall bladder cancer Carcinoid tumor Sarcoma Mesothelioma Uterine sarcoma Carcinoid Tumor Gallbladder Neoplasms Fallopian tube cancer Gastrointestinal Stromal Tumors Adenocarcinoma |