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Phase II Trial of Brentuximab Vedotin (SGN-35) at Dose of 1.8 mg/kg IV Every 3 Weeks in Patients With CD30-positive Lymphoproliferative Disorders (Cutaneous Anaplastic Large T-cell Lymphoma (ALCL), Mycosis Fungoides, and Extensive Lymphomatoid Papulosis (LyP)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
CD-30 Positive Anaplastic Large T-cell Cutaneous Lymphoma, Lymphoma, Primary Cutaneous Anaplastic Large Cell, Lymphomatoid Papulosis, Mycosis Fungoides, Skin Lymphoma, Cutaneous Lymphomas, Lymphoma, Hematologic Disorder

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Trial Information

Phase II Trial of Brentuximab Vedotin (SGN-35) at Dose of 1.8 mg/kg IV Every 3 Weeks in Patients With CD30-positive Lymphoproliferative Disorders (Cutaneous Anaplastic Large T-cell Lymphoma (ALCL), Mycosis Fungoides, and Extensive Lymphomatoid Papulosis (LyP)


The Study Drug:

Brentuximab vedotin is an antibody that is designed to find a certain protein (called CD30)
on cancer cells and bind to it. It is designed to then enter the cell and release a
molecule that may kill the cancer cells.

Study Drug Administration:

If you are found eligible to take part in this study, you will begin receiving brentuximab
vedotin by vein over 30 minutes on Day 1 of each 21-day study cycle. If you have side
effects after your first dose and your doctor thinks it is in your best interest, future
doses may be lowered or delayed for up to 3 weeks.

Premedications:

If you have any reactions at the infusion site after you receive the study drug during Cycle
1, you may be given acetaminophen (Tylenol) or diphenhydramine (Benadryl) 30-60 minutes
before all following infusions.

Study Visits:

At each clinic visit, including follow-up visits (described below), you will have full skin
exams. You will be checked to see how much of your skin's surface has lesions. Up to 6 skin
lesions will be selected to be photographed and measured at each visit. Your private areas
will be covered (as much as possible), and a picture of your face will not be taken unless
there are lesions on your face. You will not be able to be identified in the photographs.
The following tests and procedures will also be performed:

On Day 1 of all study cycles (before you receive the study drug):

- You will have a physical exam.

- Your performance status will be recorded.

- You will be asked about any drugs that you may be taking and if you are having any side
effects.

- You will fill out the 3 quality-of-life questionnaires.

- Blood (about 4-6 teaspoons) will be drawn for routine tests and to check the status of
the disease.

- If you have not had a lesion biopsy within the last 6 weeks you will have a lesion
biopsy to check the status of the disease and for PGx testing.

Length of Study Treatment:

You may receive the study drug for up to 8 cycles. You will be taken off study if the
disease gets worse or intolerable side effects occur.

If the disease has a complete response, you may receive the study drug for 2 more cycles if
the study doctor thinks it is in your best interest.

If the disease has complete response, then comes back, you may receive the study drug for 8
more cycles if the doctor thinks it is in your best interest.

If you are doing better at the end of 8 cycles but the disease is not in complete
remission, the study doctor may allow you to receive the study drug every 3 weeks at the
full dose or every 2 weeks at a lower dose for up to 8 additional cycles.

Follow-up Visits:

About 3-4 weeks after you have stopped taking the study drug, the following tests and
procedures will be performed:

- Your medical history will be recorded.

- Your performance status will be recorded.

- You will have a physical exam.

- You will be asked if you are having any side effects.

- You will fill out the 3 quality-of-life questionnaires.

- Blood (about 4-6 teaspoons) will be drawn for routine tests and to check the status of
the disease.

- You will have a CT or PET scan to check the status of the disease.

- You will have a lesion biopsy to check the status of the disease and for PGx testing.

About 6-8 weeks after you have stopped taking the study drug, the following tests and
procedures will be performed:

- You will have a physical exam.

- You will be asked about any side effects you may be having.

At 12 weeks after you have stopped taking the study drug and every 12 weeks after that
until the disease gets worse or the study is no longer open:

- You will have a physical exam.

- You will be asked about any side effects you may be having.

- Your medical history will be recorded.

This is an investigational study. Brentuximab vedotin is not FDA approved or commercially
available for use in patients with ALCL, LyP or MF. It is currently being used for research
purposes only.

Up to 84 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Patients must have a biopsy confirmed diagnosis based on a combination of
histological and clinical criteria of CD30+ lymphomatoid papulosis, CD30+ primary
cutaneous anaplastic large T-cell lymphoma (pc-ALCL), or CD30+ mycosis fungoides for
the phase II trial. There is no specific limit or validated amount other than
positive cells on 1HC cells in tumor cells.

2. Patients with pc-ALCL that has spread systemically (e.g. to lymph nodes, bone marrow
or visceral organs) may be included so long as pc-ALCL was the primary diagnosis for
at least 6 months before systemic involvement was confirmed. MF patients must be
stage IB or greater.

3. Systemic involvement (i.e., nodal, bone marrow or visceral organ involvement) will be
evaluated by CT and/or PET and bone marrow biopsy(if indicated on patients with blood
involvement) in patients with pc-ALCL or MF at baseline.

4. Patients' biopsies must be histologically confirmed CD30 positive within 36 months of
enrollment.

5. pc-ALCL and MF patients must have progressed or relapsed after treatment with local
radiation therapy, phototherapy, topical chemotherapy, or have failed systemic
therapy of at least one single agent (e.g., methotrexate or bexarotene or other
non-CD30 antibody) or one multi-agent chemotherapy (e.g. CHOP: cyclophosphamide,
doxorubicin, vincristine, and prednisone). pc-ALCL classified patients are required
to have one or more cutaneous tumors that by history have been present for at least 3
months.

6. All patients must be considered an eligible candidate for systemic therapy as
determined by the investigator. To be eligible, LYP patients must be in need of
systemic therapy ie have scarring or active lesions (>/=10 per month), or any number
of active lesions on face, hands or feet.

7. Patients must have the following minimum wash-out from previous treatments: a. >/= 4
weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment
with other anticancer investigational agents. b. > 2 weeks for oral methotrexate,
retinoids or biological response modifiers therapy for any indication, or topical
prescription or topical therapy. c. >/= 12 weeks for any immunotherapy (e.g.,
monoclonal antibody). Patients with rapidly progressive disease may be treated
earlier than the required washout period; patients should have recovered from prior
treatment-related toxicities

8. Patients must have an ECOG performance status of
9. Patients must be at least 18 years of age.

10. Patients must be available for periodic blood sampling, study-related assessments,
and management of toxicity at the treating institution.

11. Females of childbearing potential [a female not post menopausal for at least 12
months or not surgically sterilized] must have a negative beta-HCG pregnancy days prior to Day 1 of Cycle 1. If the pregnancy test is outside institutional normal
range at pretreatment, the subject must have a second pregnancy test. If the second
pregnancy test is outside institutional normal range then a gynecology consult is
needed to confirm the subject is not pregnant. All patients must agree to use an
effective contraceptive method during the course of the study.

12. Patients must give written informed consent. A copy of the signed informed consent
form will be retained in the patient's chart.

13. The following required baseline laboratory data: absolute neutrophil count (ANC) >/=
1000/microliter, platelets >/= 50,000/┬ÁL (unless documented bone marrow involvement
with lymphoma), bilirubin patients with Gilbert's disease, serum creatinine aminotransferase (ALT) and aspartate aminotransferase (AST)
Exclusion Criteria:

1. Concomitant corticosteroid use for systemic or topical treatment of skin disease is
not allowed except a dose of steroid of no more than 20 mg of prednisone or its
equivalence is allowed of asthma, COPD or IBD .Stable use of topical corticosteroids
of mid-potency will be allowed for patients with erythroderma-Sezary syndrome (T4)
and tumor stage (T3) with intense pruritus.

2. Patients with known grade 3 or higher (per CTCAE v.4.0 criteria) active systemic or
cutaneous viral, bacterial or fungal infection.

3. Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.

4. Patients with known hypersensitivity to recombinant proteins or any excipient
contained in the drug formulation that includes trehalose, sodium citrate, and
polysorbate 80.

5. Patient with a history of other malignancies during the past three years. (The
following are exempt from the 3-year limit: non-melanoma skin cancer, melanoma in
situ, curatively treated localized prostate cancer, and cervical carcinoma in situ on
biopsy or a squamous intraepithelial lesion on PAP smear.)

6. Patients with congestive heart failure, Class III or IV, by the NYHA criteria.

7. Patients who are pregnant or breastfeeding.

8. Patients with any serious underlying medical condition that would impair their
ability to receive or tolerate the planned treatment.

9. Patients with dementia or altered mental status that would preclude understanding and
rendering of informed consent.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Description:

Response rate is percentage of participants with skin lesions that express CD30+ receiving SGN-35 in primary cutaneous ALCL, MF, and extensive lymphomatoid papulosis whose best response during the observation period is a Partial Response (PR), regression of measurable disease, or Complete Response (CR), complete disappearance of all clinical evidence of disease, (i.e. at least moderate improvement). Objective tumor response (PR, CR, PR+CR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Madeleine Duvic, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2010-0914

NCT ID:

NCT01352520

Start Date:

June 2011

Completion Date:

Related Keywords:

  • CD-30 Positive Anaplastic Large T-cell Cutaneous Lymphoma
  • Lymphoma, Primary Cutaneous Anaplastic Large Cell
  • Lymphomatoid Papulosis
  • Mycosis Fungoides
  • Skin Lymphoma
  • Cutaneous Lymphomas
  • Lymphoma
  • Hematologic Disorder
  • systemic therapy
  • cutaneous anaplastic large T cell lymphoma
  • ALCL
  • lymphomatoid papulosis
  • LyP
  • mycosis fungoides
  • MF
  • SGN-35 (brentuximab vedotin)
  • skin lymphomas
  • CD30-positive lymphoproliferative disorders
  • tumor lymphocytes
  • cutaneous lymphomas
  • CD30+ expression
  • Hematologic Disorder
  • Lymphoma
  • Hematologic Diseases
  • Lymphoma
  • Lymphoproliferative Disorders
  • Mycoses
  • Mycosis Fungoides
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphomatoid Papulosis
  • Lymphoma, Primary Cutaneous Anaplastic Large Cell

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030