Trial Search Results
Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
The main purpose of this study is to determine if KW-0761 will work against cutaneous T-cell lymphoma (CTCL) that has failed to respond to other treatments, and to evaluate its side effects.
KW-0761 is an antibody. Antibodies are proteins which the immune system, your body’s defense system, uses to recognize foreign or unwanted material, such as infection or some cancers. Antibodies are used to try to destroy cancer cells while causing little harm to normal cells. The cancer cells of many patients with T-cell lymphoma contain a protein called CCR4. KW-0761 is an antibody that finds T-cells that have a protein called CCR4 on their surface and attempts to destroy them.
Stanford is currently not accepting patients for this trial.
Kyowa Kirin Pharmaceutical Development, Inc.
- Biological: KW-0761
- Drug: Vorinostat
- 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
- 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
- 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
- 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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study