Study on SGN-35 for Treating CD30-positive Skin Lymphomas

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT01352520

Provider View

This clinical trial is testing a drug called SGN-35 (brentuximab vedotin) to see if it can help control certain skin lymphomas, including ALCL, LyP, and MF. The study also aims to evaluate the safety of the drug.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drug SGN-35 (brentuximab vedotin) can help manage three types of skin lymphomas: ALCL, LyP, and MF. The study will also look at how safe the drug is for patients. Brentuximab vedotin is designed to target a protein called CD30 on cancer cells, enter the cells, and release a substance that may kill them.

Description

In this study, participants will receive the drug brentuximab vedotin through an IV infusion over 30 minutes on the first day of each 21-day cycle. If side effects occur, the doctor may adjust the dose or delay treatment. If you experience any reactions during the first infusion, you may be given medications like Tylenol or Benadryl before future infusions.

During each clinic visit, doctors will perform full skin exams and take photographs of up to 6 skin lesions to track changes. Your face will not be photographed unless there are lesions present. Other tests include physical exams, blood tests, and questionnaires about your quality of life and symptoms.

You may receive the study drug for up to 8 cycles, but treatment will stop if the disease worsens or side effects become intolerable. If the disease responds well, you may continue treatment for additional cycles as advised by your doctor.

After stopping the study drug, follow-up visits will include medical history reviews, physical exams, blood tests, and scans to check the status of the disease. Long-term follow-up will occur every few months for up to 5 years.

This study is investigational for LyP and MF, but brentuximab vedotin is FDA approved for ALCL. Participants will receive parking coupons for clinic visits. Up to 84 patients will participate, all at MD Anderson.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of CD30+ lymphomatoid papulosis, CD30+ primary cutaneous anaplastic large T-cell lymphoma (pc-ALCL), or CD30+ mycosis fungoides.
  • For pc-ALCL, the disease may have spread to other parts of the body, but the primary diagnosis must have been made at least 6 months prior.
  • Must have progressed or relapsed after previous treatments like radiation, phototherapy, or chemotherapy.
  • Must be eligible for systemic therapy.
  • Must have a minimum wash-out period from previous treatments.
  • Must have an ECOG performance status of 0-2.
  • Must be at least 18 years old.
  • Must be available for study-related assessments and management.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must provide written informed consent.
  • Must meet specific baseline laboratory criteria.

Exclusion Criteria

  • Cannot use corticosteroids for skin disease treatment, except for certain conditions.
  • Cannot have active infections or be HIV, Hepatitis B, or Hepatitis C positive.
  • Cannot have allergies to the study drug components.
  • Cannot have had other cancers in the past three years, with some exceptions.
  • Cannot have severe heart failure.
  • Cannot be pregnant or breastfeeding.
  • Cannot have serious medical conditions that would affect treatment.
  • Cannot have dementia or mental status changes that affect consent.

Locations

FACILITYZIPCITYSTATE
University of Texas MD Anderson Cancer Center77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.