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OpenTrials
Completed

NCT Number: NCT00656123

Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer

The primary objective of this study is to evaluate the safety and feasibility of vaccination with two irradiated allogeneic colorectal carcinoma cells administered with a GM-CSF producing bystander cell line in sequence with an immunomodulatory dose of Cyclophosphamide

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented metastatic colorectal cancer
  • ECOG Performance Status of 0 to 1
  • Adequate organ function as defined by study-specified laboratory tests
  • Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
  • Signed informed consent form
  • Life expectance > 12 weeks

Exclusion criteria

  • Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune, or other medical conditions
  • Systemically active steroid use
  • Another investigational product within 28 days prior to receiving study drug
  • Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug
  • Chemotherapy, radiation, or biological cancer therapy within 28 days prior to receiving study drug
  • No known history or evidence of CNS metastases < 2 years.
  • Pregnant or lactating
  • Unwilling or unable to comply with study procedures

Treatment and study plan

Colon GVAX

Biological

Dose escalation: 1.4x10^8 to 7x10^8 cells administered in up to 15 intradermal injections on Day 2 of Cycles 1-4

Other names: Allogeneic Colon Cancer Cell Vaccine Administered with a Granulocyte-Macrophage Colony Stimulating Factor-Producing Bystander Cell Line

Cyclophosphamide

Drug

200 mg/m^2 administered IV on Day 1 of Cycles 1-4

Primary outcomes

  1. Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity

    Time frame: 3.5 years

    When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v3) will be counted only once for a given subject.

Secondary outcomes

  1. Percent Fold change in amount of interferon gamma-producing Ep-CAM-specific CD8 T cells after vaccination

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Safety and Feasibility Study of an Allogeneic Colon Cancer Cell Vaccine Administered With a GM-CSF Producing Bystander Cell Line in Patients With Metastatic Colorectal Cancer

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Apr 10, 2008
Registry last updated
Aug 14, 2019

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.

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