Gemcitabine Hydrochloride for Non-Hodgkin Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Hodgkin Lymphoma+13 MoreGemcitabine Hydrochloride - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the side effects of directly injecting drugs into tumors and using FDG-PET to see which drugs are most effective in treating non-Hodgkin lymphoma, Hodgkin lymphoma, or breast cancer.

Eligible Conditions
  • Non-Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Refractory Hodgkin Lymphoma
  • Breast Cancer
  • Mycosis Fungoides
  • Refractory Breast Cancer
  • Cutaneous T-Cell Lymphoma
  • Refractory Nodal Marginal Zone Lymphoma
  • Stage IV Breast Cancer
  • Refractory Non-Hodgkin Lymphoma
  • Metastatic Breast Cancer
  • Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 3 months

Up to 3 months
Apoptosis in response to intratumoral injection
Feasibility
Heart rate
Incidence of adverse events
Anniversary Reaction
Day 5
Nodal disease response rate
Day 7
Cutaneous response rate
Cutaneous response rate based upon the modified Severity Weighted Assessment Tool score

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Treatment (FDG-PET, direct tumor microinjection)
1 of 1

Experimental Treatment

39 Total Participants · 1 Treatment Group

Primary Treatment: Gemcitabine Hydrochloride · No Placebo Group · Phase 1

Treatment (FDG-PET, direct tumor microinjection)Experimental Group · 15 Interventions: Trastuzumab, Positron Emission Tomography, Copanlisib Hydrochloride, Saline, Gemcitabine Hydrochloride, Daratumumab, Laboratory Biomarker Analysis, Nivolumab, Obinutuzumab, Belinostat, Carfilzomib, Fludeoxyglucose F-18, Pembrolizumab, Rituximab, Romidepsin · Intervention Types: Biological, Procedure, Drug, Other, Drug, Biological, Other, Biological, Biological, Drug, Drug, Drug, Biological, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Positron Emission Tomography
2008
Completed Phase 2
~2820
Gemcitabine
FDA approved
Daratumumab
FDA approved
Nivolumab
FDA approved
Obinutuzumab
FDA approved
Belinostat
FDA approved
Carfilzomib
FDA approved
Fludeoxyglucose (18F)
FDA approved
Pembrolizumab
FDA approved
Rituximab
FDA approved
Romidepsin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 months

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,084 Previous Clinical Trials
41,141,605 Total Patients Enrolled
Mayo ClinicLead Sponsor
2,922 Previous Clinical Trials
3,517,114 Total Patients Enrolled
Grzegorz S NowakowskiPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
412 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
(IR) on MRI, Cohort II: For nodal/extranodal mass, no lesions amenable for injections as determined by IR on MRI For nodal/extranodal masses, Cohort I includes those with lesions that are amenable for injections as determined by IR on MRI, whereas Cohort II includes those without lesions amenable for injections as determined by IR on MRI.
A person has non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) if they have a nodal or extranodal mass
The Text: The exam must include a review of the patient's history and a physical examination, including a breast examination and assessment of the lymph nodes
The patient is not a candidate for any curative therapy or any known life-prolonging therapy.
For nodal or extranodal disease (lymphoma or breast): Must have at least 2 lesions that are >= 20 mm (2.0 cm) in the longest diameter by physical exam and/or on cross-sectional imaging
Dermatologic lesions (either lymphoma or breast) that are greater than 1 cm and visible, without infection, and can be injected with medication will be candidates for further therapy
Patients who haven't responded to other treatments or can't tolerate them may be good candidates for this therapy.
The patient must have an ANC of 1000/mm^3 or greater that was obtained less than 14 days before they register for the study.