A Phase 2 Intratumoral Injection PF-3512676 Plus Local Radiation in Low-Grade B-Cell Lymphomas
NCT00880581
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- Biopsy confirmed low-grade B-cell lymphoma diagnosed as follicular grade 1 or 2, marginal zone or small lymphocytic lymphoma of any initial stage.
- Patients may be either treatment-naïve; relapsed from; or refractory to prior therapy. (15 treatment-naïve and 15 relapsed/refractory patients will be enrolled)
- Patients must have at least one site of disease that is accessible for intratumoral injection of PF-3512676 percutaneously
- Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the study.
- Patients must have measurable disease other than the injection site or biopsy site.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≥ 1
- Karnofsky Performance Status (KPS) of ≥ 70
- ≥ 18 years of age
- White blood cells (WBC) ≥ 2,000/uL
- Platelet count ≥ 75,000/mm³
- Absolute neutrophil count (ANC) ≥ 1000
- Serum creatinine ≤ 2.0 mg/dL.
- Bilirubin ≤ 1.5 mg/dL
- Serum glutamic oxalocetic transaminase (SGOT) / serum glutamic pyruvic transaminase (SGPT) ratio < 3 x upper limit of normal (ULN)
- Required wash out periods for prior therapy:
- Topical therapy: 2 weeks
- Chemotherapy: 4 weeks
- Radiotherapy: 4 weeks
- Other investigational therapy: 4 weeks
- Rituximab: 12 weeks
- 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.
- Women of reproductive potential must have a negative urine pregnancy test.
- Life expectancy > 4 months.
- Able to comply with the treatment schedule.
- Ability to understand and the willingness to sign a written informed consent document.
- Pre-existing autoimmune or antibody mediated disease including:
- Systemic lupus, erythematosus
- Rheumatoid arthritis
- Multiple sclerosis
- Sjogren's syndrome
- Autoimmune thrombocytopenia, but excluding controlled thyroid disease
- Presence of autoantibodies without clinical autoimmune disease.
- Known history of human immunodeficiency virus (HIV).
- Patients with active infection or with a fever > 38.5 C within 3 days prior to the
first scheduled treatment.
- Central nervous system (CNS) metastases
- Prior malignancy (active within 5 years of screening) except basal cell or completely
excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell
carcinoma of the cervix.
- History of allergic reactions attributed to compounds of similar composition to
PF-3512676
- Current anticoagulant therapy [aspirin (ASA) ≤ 325 mg per day allowed]
- Significant cardiovascular disease [ie, New York Heart Association (NYHA) class 3
congestive heart failure; myocardial infarction with the past 6 months; unstable
angina; coronary angioplasty with the past 6 months; uncontrolled atrial or
ventricular cardiac arrhythmias].
- Pregnant or lactating.
- Any other medical history, including laboratory results, deemed by the investigator to
be likely to interfere with their participation in the study, or to interfere with the
interpretation of the results.
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- Stanford, California
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | A Phase 2 Intratumoral Injection PF-3512676 Plus Local Radiation in Low-Grade B-Cell Lymphomas | ||||
| Official Title ICMJE | A Phase 2 Study of Intratumoral Injection PF-3512676 in Combination With Local Radiation in Low-Grade B-Cell Lymphomas | ||||
| Brief Summary | To assess the feasibility of using intra-tumoral PF-3512676 in combination with local radiation as a therapy for lowgrade b-cell lymphoma. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: PF-3512676
Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks. Interventions:
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| Publications * | Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, Lister TA, Vose J, Grillo-López A, Hagenbeek A, Cabanillas F, Klippensten D, Hiddemann W, Castellino R, Harris NL, Armitage JO, Carter W, Hoppe R, Canellos GP. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999 Apr;17(4):1244. Review. Erratum in: J Clin Oncol 2000 Jun;18(11):2351. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE | 30 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | January 2015 | ||||
| Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00880581 | ||||
| Other Study ID Numbers ICMJE | IRB-14820 SU-03272009-2038 ( Other Identifier: SU IRB ) LYMNHL0064 ( Other Identifier: OnCore ) | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Ronald Levy, Stanford University | ||||
| Study Sponsor ICMJE | Ronald Levy | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
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| PRS Account | Stanford University | ||||
| Verification Date | January 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||