Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level
Brief Summary: The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options, the treatments are associated with short response duration, thus this condition is largely incurable. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting.


Options:
A: Inclusion Criteria:

* Biopsy-proven MF/SS, stage IB-IVB, and failed one standard systemic therapy. Skin biopsy must be within 3 months of beginning study medication
* At least the following wash-out from prior treatments:

  * ≥ 3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-cancer investigational agents (including monoclonal antibody)
  * \> 3 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox and phototherapy
  * \> 2 wks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)
* At least 18 years of age
* ECOG performance status of ≤ 2
* Must be able to commit to study schedule
* Absolute neutrophil count (ANC) ≥ 1000/uL
* Platelets ≥ 50,000/uL
* Bilirubin ≤ 2X upper limit of normal (ULN) (EXCEPTION: Gilbert's disease ≤ 3X ULN)
* Serum creatinine ≤ 2X ULN
* Alanine aminotransferase (ALT) ≤ 3X ULN
* Aspartate aminotransferase (AST) ≤ 3X ULN
* Negative serum beta-HCG pregnancy test result within 7 days of first treatment, if a woman of childbearing potential
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Mycosis fungoides (MF) with limited disease (stage IA) or central nervous system (CNS) disease
* Systemic or topical concomitant corticosteroid use for treatment of skin disease (EXCEPTION: Oral prednisone allowed at ≤ 10 mg/day)
* Known Grade 3 or higher (per NCI CTCAE v4.0 criteria) active systemic or cutaneous viral, bacterial, or fungal infection
* Known to be Hepatitis B or Hepatitis C antibody positive
* HIV-positive with have a measurable viral load while on antiretroviral medication
* Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
* History of other malignancies during the past 3 years (EXCEPTIONS: non-melanoma skin cancer; curatively treated localized prostate cancer; curatively treated localized breast cancer; resected thyroid cancer; cervical intraepithelial neoplasia; or cervical carcinoma in situ on biopsy).
* Pregnant
* Breastfeeding
* Congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria.
* Any serious underlying medical condition that would impair subject's ability to receive or tolerate the planned treatment.
* Dementia or altered mental status that would preclude subject's understanding and rendering of informed consent.
B: DISEASE CHARACTERISTICS:

* Histologically confirmed mycosis fungoides

  * Stage IIB, IVA, or IVB
* Refractory or recurrent disease after at least 2 of the following prior therapies:

  * Local and/or systemic steroids
  * Retinoids
  * Interferon alfa
  * Local carmustine
  * Systemic chemotherapy
  * Psoralen and ultraviolet A (PUVA) light therapy
* No CNS involvement
* No erythroderma (T4)

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* Neutrophil count at least 1,500/mm\^3
* WBC at least 2,000/mm\^3
* Platelet count at least 75,000/mm\^3
* Hemoglobin at least 10 g/dL

Hepatic

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT no greater than 2.5 times ULN

Renal

* Creatinine no greater than 1.5 times ULN

Cardiovascular

* LVEF normal by echocardiography or radionuclide angiocardiography

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 2 years after study participation
* No psychological, familial, sociological, or geographical condition that would preclude study compliance or follow-up
* No active infection requiring specific therapy (e.g., antibiotics or anti-HIV therapy)
* No other prior or concurrent primary malignant tumor except adequately treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics
* More than 2 weeks since prior immunotherapy

Chemotherapy

* See Disease Characteristics
* Prior systemic chemotherapy allowed provided all of the following conditions are met:

  * Cumulative anthracycline dose is less than 200 mg/m\^2
  * No allergy to anthracyclines
  * Prior methotrexate is low dose (i.e., weekly dose less than 30 mg)
* More than 2 weeks since prior chemotherapy

Endocrine therapy

* See Disease Characteristics
* No concurrent systemic steroids

Radiotherapy

* More than 2 weeks since prior radiotherapy

Surgery

* Not specified

Other

* Recovered from toxic effects of prior therapy, excluding alopecia
* No other concurrent anticancer therapy
C: Inclusion Criteria:

* Male and female subjects ≥ 18 years of age at the time of enrollment, except in Japan where subjects must be ≥ 20 years of age at the time of enrollment
* Histologically confirmed diagnosis of mycosis fungoides (MF) or Sezary Syndrome (SS)
* Stage IB, II-A, II-B, III and IV
* Subjects who had failed at least one prior course of systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy
* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at study entry
* Resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0)
* Adequate hematological, renal and hepatic function
* Subjects previously treated with anti-CD4 antibody or alemtuzumab were eligible provided their CD4+ cell counts were ≥ 200/mm3
* Subjects with mycosis fungoides (MF) and a known history of non-complicated staphylococcus infection/colonization were eligible provided they continued to receive stable doses of prophylactic antibiotics
* Women of childbearing potential (WOCBP) must have had a negative pregnancy test within 7 days of receiving study medication
* WOCBP and male subjects as well as their female partners of childbearing potential must have agreed to use effective contraception throughout the study and for 3 months after the last dose of KW-0761

Exclusion Criteria:

* Prior treatment with KW-0761 or vorinostat.
* Large cell transformation. However, subjects with a history of LCT but without current aggressive disease and no current evidence of LCT on pathology in skin and lymph nodes would be eligible.
* Diagnosed with a malignancy in the past two years. However, subjects with non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current PSA of \<0.1 ng/mL, treated thyroid cancer or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast within the past two years could enroll as long as there was no current evidence of disease.
* Clinical evidence of central nervous system (CNS) metastasis.
* Psychiatric illness, disability or social situation that would have compromised the subject's safety or ability to provide consent, or limited compliance with study requirements.
* Significant uncontrolled intercurrent illness
* Known or tested positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B or hepatitis C.
* Active herpes simplex or herpes zoster. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, and had no active signs of active infection, and whose last active infection was more than 6 months ago, could enter the study, and should have continued to take the prescribed medication for the duration of the study.
* Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
* Known active autoimmune disease were excluded. (For example, Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).
* Was pregnant (confirmed by beta human chorionic gonadotrophin \[β-HCG\]) or lactating.
* History of allogeneic transplant.
D: Inclusion Criteria:

* Voluntary consent form
* Male or female participants 18 years or older with diagnosis of mycosis fungoides (MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL)
* Participants with pcALCL who have received prior radiation therapy or at least 1 prior systemic therapy; participants with MF who have received at least 1 prior systemic therapy
* Histologically confirmed CD30+ disease by central laboratory assessment and pathology review
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant
* Male participants who agree to practice effective barrier contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant
* Clinical laboratory values as specified in protocol
* A 3-week washout period is required from previous treatments (with the exception of a 12-week washout for antibody-directed or immunoglobulin-based immune therapy, or other monoclonal antibody therapies), unless it is not in the best interest of the patient in the opinion of the investigator. Individual cases should be discussed with the project clinician before enrollment.

Exclusion Criteria:

* A concurrent diagnosis of systemic ALCL, or other non Hodgkin lymphoma (excluding LyP) or Sezary syndrome or B2 disease
* Participants with cardiovascular conditions specified in protocols
* Participants with history of another primary malignancy not in remission for at least 3 years
* Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML);
* Known human immunodeficiency virus (HIV) infection, hepatitis B or Hepatitis C infection
* Oral retinoid therapy for any indication within 3 weeks of study entry
* Corticosteroid therapy within 3 weeks or immunosuppressive chemotherapy or any antibody-directed or immunoglobulin-based immune therapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first dose of study drug
* Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 of any cycle
* Previous receipt of brentuximab vedotin Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

Answer: A