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| Sponsor: | Stanford University |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00880581 |
Purpose
To assess the feasibility of using intra-tumoral PF-3512676 in combination with local radiation as a therapy for lowgrade b-cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: PF-3512676 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study of Intratumoral Injection PF-3512676 in Combination With Local Radiation in Low-Grade B-Cell Lymphomas |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:1. Biopsy confirmed low-grade B-cell lymphoma, specifically, follicular grade 1 or 2, marginal zone or small lymphocytic lymphoma, of any initial stage. Patients may be either treatment-naïve or relapsed from or refractory to prior therapy. Fifteen treatment-naïve and 15 relapsed/refractory patients will be enrolled.
2. Patients must have at least one site of disease that is accessible for intratumoral injection of PF-3512676 percutaneously
3. Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the study.
4. Patients must have measurable disease other than the injection site or biopsy site.
5. ECOG Performance Status of 1 or better (corresponds to Karnofsky Performance Status (KPS) of >= 70)
6. Patients must be 18 years of age or older.
7. Adequate bone marrow function: WBC >= 2,000/uL; platelet count >= 75,000/mm3; ANC>= 1000.
8. Adequate renal function: serum creatinine <= 2.0mg/dL.
9. Adequate hepatic function: bilirubin <=1.5 mg/dL; SGOT/SGPT < 3 x upper limit of normal
10.Required wash out periods for prior therapy:
Rituximab: 12 weeks
11.Patients of reproductive potential and their partners must agree to use an effective (>90% reliability) form of contraception during the study and for 4 weeks following the last study drug administration.
12.Women of reproductive potential must have negative urine pregnancy test. 13.Life expectancy greater than 4 months. 14.Able to comply with the treatment schedule. 15.Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:A patient may not be enrolled in the trial if any of the following criteria are met:
The principal investigator may grant a protocol exemption in cases where a patient would be ineligible based on one or more exclusion criteria but would be a good candidate for the study. In this case, a note to file must be generated to explain the inclusion of the patient.
Contacts and Locations| Contact: Emily Troutner | (650) 725-4968 | troutner@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Emily Troutner 650-725-4968 troutner@stanford.edu | |
| Contact: Lori Richards (650) 725-4968 lorir@stanford.edu | |
| Principal Investigator: Ronald Levy | |
| Sub-Investigator: Joshua Brody | |
| Principal Investigator: | Ronald Levy | Stanford University |
More Information
| Responsible Party: | Stanford University School of Medicine ( Ronald Levy, Principal Investigator ) |
| Study ID Numbers: | SU-03272009-2038, LYMNHL0064 |
| Study First Received: | April 10, 2009 |
| Last Updated: | July 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00880581 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Lymphoma, B-Cell Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |