Skip to main content
OpenTrials
Completed

NCT Number: NCT00003431

Flt3L in Treating Patients With Metastatic Colorectal Cancer

RATIONALE: Flt3L may stimulate a person's immune system and help kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of flt3L given to patients before undergoing surgery to remove metastases from colorectal cancer.

Completed

Looking for future studies?

Notify Me

Key information

About this study

OBJECTIVES: I. Evaluate the safety and feasibility of administering flt3 ligand to patients with hepatic metastases from colorectal cancer prior to surgical resection.

OUTLINE: Patients receive flt3 ligand subcutaneously for 14 days followed by 14 days of rest. This course of therapy may be repeated for a total of 3 courses. Leukapheresis is performed on day 15 of the last course of Flt3 ligand. Patients undergo restaging and metastasis resection. Patients are followed every 3 months for the first year, every 6 months for the second year, and yearly thereafter.

PROJECTED ACCRUAL: This study will accrue 12 patients in 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS: Histologically confirmed metastatic colon cancer expressing carcinoembryonic antigen (CEA) At least 50% of tumor cells must express CEA with at least moderate intensity Resectable hepatic metastases or other site of metastatic colon cancer that is resectable (e.g., lung metastases)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1000/mm3 Absolute lymphocyte count at least 1000/mm3 Hemoglobin at least 9 mg/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL No hepatic disease Renal: Creatinine less than 2.5 mg/dL Cardiovascular: No ongoing cardiac disease No New York Heart Association class III or IV heart disease Pulmonary: No ongoing pulmonary disease such as: Asthma Chronic obstructive pulmonary disease (COPD) Active radiation- or drug-induced pneumonitis Other: Not pregnant or nursing Fertile patients must use effective contraception No history of autoimmune disease such as but not limited to: Inflammatory bowel disease Systemic lupus erythematosus Ankylosing spondylitis Scleroderma Type I diabetes Multiple sclerosis No other serious ongoing chronic or acute illness No medical or psychological impediment to study compliance No concurrent or prior second malignancy except: Nonmelanoma skin cancer Controlled superficial bladder cancer within the last 5 years No active or chronic infection including: Urinary tract infection HIV Viral hepatitis

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids No concurrent hormone therapy Radiotherapy: No concurrent radiation therapy Surgery: No specified Other: No immunosuppressives such as: Azathioprine Cyclosporine A

Treatment and study plan

recombinant flt3 ligand

Biological

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pilot Study of FLT3 Ligand Prior to Resection of Hepatic Metastases of Colorectal Cancer

Important dates

Study start
1998
Study completion
2001
First posted
Aug 4, 2004
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.