A Study to Evaluate Feasibility of In Vivo Sensitivity Screen Using Direct Tumor Microinjection and FDG-PET in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer

Overview

About this study

The purpose of this study is to assess the safety of in vivo in host drug sensitivity testing in patients with breast cancer and patients with lymphoma (nodal, extranodal masses, or cutaneous lesions).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically proven of relapsed or refractory.
  • NHL or HL nodal or extranodal mass; OR
  • CTCL including mycosis fungoides (MF), as well as transformed MF; OR
  • Breast adenocarcinoma with nodal or cutaneous metastases (Stage 4).
    • Note:   Patients must be refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
    • Note:   The patient must not be a candidate for any curative therapy or any known life-prolonging therapy
  • Cohort I: For nodal/extranodal mass, presence of lesions that are amenable for injections as determined by interventional radiology.
    • Note: Nodal or extranodal mass must be palpable and easily accessible.  Masses such as mediastinum, retroperitoneum, within solid organs, spinal sites, CNS sites, etc., are NOT allowed.
  • Measurable disease:
    • For nodal or extranodal disease (lymphoma or breast):
      • Must have at least 2 lesions that are ≥ 20mm (2.0 cm) in the longest diameter by physical exam and/or on cross-sectional imaging and measureable in two perpendicular dimensions per computed tomography PET-CT;
      • For Cohort I, the lesions must be amenable to intralesional injections as determined by Interventional Radiology (including tumors that can be safely accessed using imaging guidance and treated with minimal risk to adjacent structures).
  • For cutaneous lesions (lymphoma or breast):
    • At least two visible, non-infected skin lesions that are greater than 1 cm and are amenable to intralesional injection as determined by investigator.  
  • Candidate for further therapy and able to wait 7 days prior to start of next systemic therapy.
  • The following laboratory values obtained ≤ 14 days prior to registration:
    • Absolute neutrophil count (ANC) ≥ 1000/mm^3;
    • Platelet count ≥ 50,000/mm^3;
    • INR/PT ≤ 1.5.
  • Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
  • Wiling and able to provide written informed consent.
  • Willing to return to enrolling institution for follow-up.
  • Willing to provide tissue samples for correlative research purposes.

Exclusion Criteria:

  • Any of the following because this study involves an investigational agent that is genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant persons;
    • Nursing persons;
    • Persons of childbearing potential who are unwilling to employ adequate contraception.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Systemic corticosteroids between pre-PET and post-PET evaluation and biopsy.
  • Prohibited treatments and/or therapies:
    • Autologous Stem Cell Transplant (ASCT) ≤ 12 weeks prior to registration;
    • Prior chemotherapy ≤ 2 weeks prior to registration;
    • Prior treatment with nitrosureas ≤ 4 weeks prior to registration;
    • Therapeutic anticancer antibodies ≤ 2 weeks prior to registration;
    • Radio- or toxin immunoconjugates ≤ 4 weeks prior to registration;
    • Radiation therapy to the injected area ≤ 2 weeks prior to registration;
    • Major surgery ≤ 2 weeks prior to registration.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • Requires anticoagulation that cannot be discontinued prior to biopsy.
    • Note: Exception if able to hold antiplatelet agents 7 days prior to the injections and biopsy.
    • Note: LMWH will be allowed for bridging if on warfarin.
    • Note: Heparin for line patency without detectable lab abnormalities for coagulation will be allowed.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Grzegorz Nowakowski, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20401443

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