Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00083213 |
RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of intravenous VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Cancer |
Drug: aflibercept |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | An Open Label, Sequential Cohort Dose-Escalation Safety, Tolerability and Pharmacokinetic Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma |
Estimated Enrollment: | 25 |
Study Start Date: | January 2004 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive VEGF Trap IV over 1 hour on days 1 and 15 for a total of 2 doses.
Cohorts of 3-6 patients receive escalating doses of VEGF Trap until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 6 patients are treated at that dose level.
In the absence of dose-limiting toxicity, patients with stable disease or partial or complete remission may continue to receive VEGF Trap on a separate extension protocol.
Patients are followed at weeks 1, 3, and 7 and then at 3 months.
PROJECTED ACCRUAL: A maximum of 25 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 diagnosis of one of the following:
Primary or metastatic solid tumor located, by radiography, in at least one of the following sites:
Relapsed or refractory (including unresectable) disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No untreated or uncontrolled hypertension
No prior or concurrent peripheral vascular disease
Pulmonary
Immunologic
Other
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 |
Principal Investigator: | William P. Tew, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000360856, MSKCC-03137, REGENERON-VGFT-ST-0202 |
Study First Received: | May 14, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00083213 |
Health Authority: | United States: Federal Government |
recurrent grade 1 follicular lymphoma stage IV grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma stage IV grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma stage IV grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma stage IV adult diffuse small cleaved cell lymphoma recurrent adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma recurrent adult Burkitt lymphoma |
stage IV adult Burkitt lymphoma recurrent mantle cell lymphoma stage IV mantle cell lymphoma recurrent adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma unspecified adult solid tumor, protocol specific recurrent adult soft tissue sarcoma recurrent adult primary liver cancer advanced adult primary liver cancer recurrent cervical cancer stage IVA cervical cancer stage IVB cervical cancer fallopian tube cancer ovarian sarcoma recurrent ovarian epithelial cancer |
Lymphoma, Mantle-Cell Malignant mesenchymal tumor Liver neoplasms Lymphoma, small cleaved-cell, diffuse Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Ovarian epithelial cancer Lymphoma, large-cell, immunoblastic Soft tissue sarcomas Dental Caries Lymphoma, large-cell Lymphoma, B-Cell Liver Neoplasms Burkitt's lymphoma Leukemia, Lymphocytic, Chronic, B-Cell |
Vulvar Neoplasms Lymphoma, Large-Cell, Immunoblastic Endometrial cancer Lymphoma Bladder neoplasm Chronic lymphocytic leukemia Vaginal Neoplasms Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia, B-cell, chronic Urinary Bladder Neoplasms Vaginal cancer Lymphoblastic lymphoma Testicular Neoplasms Mantle cell lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |