A Phase 2 Study of Intratumoral Injection PF-3512676 in Combination With Local Radiation in Low-Grade B-Cell Lymphomas
Overview
- Phase
- Phase 2
- Intervention
- PF-3512676
- Conditions
- Lymphoma, Non-Hodgkin
- Sponsor
- Ronald Levy
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Overall ObjectiveResponse (ORR) Rate
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Ronald Levy
Robert K. and Helen K. Summy Professor in the School of Medicine
Stanford University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: PF-3512676
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.
Intervention: Local radiotherapy
Outcomes
Primary Outcomes
Overall ObjectiveResponse (ORR) Rate
Time Frame: 12 weeks
Overall objective response rate (OOR) at time of best response was assessed as the sum of the Complete Response (CR) rate and the Partial Response (CR, PR) rate. Response was assessed per the Cheson Criteria, as below. * Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease * CR/unconfirmed (CRu) = residual lymph node mass \>1.5 cm but regressed \>75%, with 1 residual lymph node mass \>1.5 cm that has regressed by \>75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia * Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR.
Secondary Outcomes
- Response Rate After Cycle 2(6 months)