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An Open-Label Phase 2 Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose-Agarose Macrobeads in the Treatment of Patients With Treatment-Resistant, Metastatic Pancreatic or Colorectal Adenocarcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer, Colorectal Cancer

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Trial Information

An Open-Label Phase 2 Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose-Agarose Macrobeads in the Treatment of Patients With Treatment-Resistant, Metastatic Pancreatic or Colorectal Adenocarcinoma


Inclusion Criteria:



- Cancer of pancreas, colon or rectum

- Evidence of metastasis

- Failed available therapies (pancreatic cancer may be treated without previous
therapies)

- Resolution of any toxic effects of previous therapies

- Performance status (ECOG PS) 0-2

- Adequate hematologic, coagulation (INR 2-3 max), hepatic and renal function

- Life expectancy of 12 months

- For females, a negative pregnancy test

- Agrees to contraceptive use while on study if sexually active

- Informed consent

Exclusion Criteria:

- Any condition presenting an unacceptably high anesthetic or surgical risk

- HIV positive

- Cognitive impairment such as to preclude informed consent

- Other surgical treatment, chemotherapy within three weeks of baseline; radiation
therapy within four weeks of baseline

- Inadequate hematologic, coagulation (INR >3), hepatic, renal function

- Hepatic blood flow abnormalities and/or large-volume ascites

- Concurrent cancer of any other type except skin cancer (excluding melanoma)

- History of allergic reactions to mouse antigens

- Active infection, congestive heart failure, unstable angina, serious cardiac
arrhythmias, psychiatric illness, difficult social situations not permitting reliable
participation, active bleeding

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor volume and number of metastases

Outcome Time Frame:

16 months

Safety Issue:

Yes

Principal Investigator

Barry H Smith, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Rogosin Institute

Authority:

United States: Food and Drug Administration

Study ID:

0911010739

NCT ID:

NCT01053013

Start Date:

February 2010

Completion Date:

October 2014

Related Keywords:

  • Pancreatic Cancer
  • Colorectal Cancer
  • macrobead
  • biological
  • mouse cells
  • Adenocarcinoma
  • Colorectal Neoplasms
  • Pancreatic Neoplasms

Name

Location

The Rogosin InstituteNew York, New York  10021