Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors
This study has been completed.
Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborator:
Pfizer
Information provided by:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00095160
First received: November 1, 2004
Last updated: October 6, 2009
Last verified: October 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Study 1493-852A is a phase 1 study with the primary objective of determining safety and the highest tolerated dose of an experimental immune response modifier administered intravenously to patients with solid organ tumors not responsive to currently available treatments. The secondary objective of the study is to monitor the tumor response to this form of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: 852A |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I, Open Label Safety, Pharmacokinetic, and Pharmacodynamic Dose Escalation/De-escalation Study of 852A Administered Intravenously to Subjects With Refractory Solid Organ Tumors |
Resource links provided by NLM:
Further study details as provided by Masonic Cancer Center, University of Minnesota:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have solid organ tumors refractory to currently available treatments.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Have a life expectancy of 4 months
- Have normal organ and bone marrow function
Exclusion Criteria:
- Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to the 1st dose of the study drug or those who have not recovered from adverse events from agents administered more than 4 weeks earlier.
- Use of investigational agent in the 4 weeks prior to 1st dose of the study drug
- Use of immunosuppressive therapy in the 4 weeks prior to the 1st dose
- Have a history of, or clinical evidence of, myocardial ischemia, congestive heart failure, or myocardial arrhythmias requiring treatment within the past 6 months
- Have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, immune dysfunction such as autoimmune disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness such as depression or suicidal tendency or social situations that would limit compliance with study requirements
- Have a history of disease requiring ongoing steroid treatment
- Have a history of seizure disorders uncontrolled on medication
- Have a history of clinically significant coagulation or bleeding disorders or abnormalities
- Are HIV positive. HIV positive subjects are excluded from the study because of possible interactions with the immunomodulatory effects of 852A and because of potential pharmacokinetic interactions associated with combination retroviral therapy.
- Are pregnant or lactating
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095160
Locations
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Pfizer
Investigators
| Principal Investigator: | Jeffrey Miller, MD | Masonic Cancer Center, University of Minnesota |
More Information
No publications provided
| Responsible Party: | Jeffrey Miller, M.D., Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00095160 History of Changes |
| Other Study ID Numbers: | 2003LS039, 1493-852A |
| Study First Received: | November 1, 2004 |
| Last Updated: | October 6, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Masonic Cancer Center, University of Minnesota:
|
Solid Organ Tumors |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013