Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic or Colorectal Cancer
This study is currently recruiting participants.
Verified April 2013 by The Rogosin Institute
Sponsor:
The Rogosin Institute
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01053013
First received: January 20, 2010
Last updated: April 8, 2013
Last verified: April 2013
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Purpose
This is a clinical research study of an investigational (FDA IND-BB 10091) treatment for patients with pancreatic cancer (all stages) and advanced colorectal cancer that no longer responds to standard therapies.
The treatment is being evaluated for its effect on tumor growth. It consists of small beads that contain mouse cancer cells from a mouse kidney cancer cell line. The cells in the beads produce substances that have been shown to slow or stop the growth of tumors in experimental animals, veterinary patients, and 23 humans with different types of cancers in a Phase 1 safety trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer Colorectal Cancer |
Biological: Cancer macrobead placement in abdominal cavity |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by The Rogosin Institute:
Primary Outcome Measures:
- Tumor volume and number of metastases [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Biological: Cancer macrobead placement in abdominal cavity
8 macrobeads per kilogram
Other Name: cancer macrobeads
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053013
Contacts
| Contact: Barry H Smith, MD, PhD | 212-746-1551 | bas2005@nyp.org |
| Contact: Nathaniel Berman, MD | 212-746-9766 | nab2009@nyp.org |
Locations
| United States, New York | |
| The Rogosin Institute | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Barry H Smith, MD, PhD 212-746-1551 bas2005@nyp.org | |
| Contact: Nathaniel Berman, MD 212-746-9766 nab2009@nyp.org | |
| Principal Investigator: Barry H Smith, MD, PhD | |
Sponsors and Collaborators
The Rogosin Institute
Investigators
| Principal Investigator: | Barry H Smith, MD, PhD | The Rogosin Institute |
More Information
No publications provided
| Responsible Party: | The Rogosin Institute |
| ClinicalTrials.gov Identifier: | NCT01053013 History of Changes |
| Other Study ID Numbers: | 0911010739 |
| Study First Received: | January 20, 2010 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The Rogosin Institute:
|
macrobead biological mouse cells |
Additional relevant MeSH terms:
|
Adenocarcinoma Colorectal Neoplasms Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013