Clinical Trials
There are many therapy choices for CTCL (MF/SS) and other cutaneous lymphomas, however none of the currently available therapies have resulted in reliable long-term response or curative results. Also, there are significant toxicities associated with many of the therapies used for patients with advanced disease. Thus, newer therapies that are more effective and safe are greatly in need. In recent years, our cutaneous lymphoma group has been involved in taking a leadership role in the research and development of new therapies in cutaneous lymphoma, whether it isin designing and leading single or multicenter new therapy trials or as part of collaborative translational research at Stanford.
Explore all Clinical Trials at Stanford »
Note: Information about closed trials may be found here.
A Randomized Phase II Study of Oral Sapacitabine in Patients with Advanced Cutaneous T-Cell Lymphoma
This is an open label, randomized, phase II study. Eligible patients will be randomized to either a high-dose (100mg) or low-dose (50mg) regimen. The study drug, sapacitabine, is an oral agent and is taken twice a day for three consecutive days per week. More »
A Phase 1, Open-label Study of Pralatrexate with Vitamin B12 and Folic Acid Supplementation in Patients with Relapsed or Refractory Cutaneous T-cell Lymphoma.
This is a Phase 1, single-arm, open-label, multi-center, dose-reduction study studying the investigational medication pralatrexate with supplementation of vitamin B12 and folic acid in patients with relapsed or refractory CTCL. More »
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma (BCX1777-203)
This is a Phase II, non-randomized, open-label, single-arm trial for the oral agent, forodesine in patients with CTCL. More »
An Open-label, Multi-center Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients with Mycosis Fungoides type CTCL (stage IB-IVB) who are Refractory or Intolerant to Targretin (bexarotene) and one other Standard Therapy [Genmab 110]
This is a double-blind, randomized, multi-center clinical trial of HuMax-CD4 sponsored by Genmab Inc. evaluating its efficacy in patients with stage IB-IVB Mycosis Fungoides who have already unsuccessfully tried Targretin. This study involves coming to the Stanford clinic for at least 15 visits during a period of 22 weeks, and every 8 weeks thereafter to evaluate the response to the trial drug. More »
A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients with Stage I or IIA Mycosis Fungoides (MF)
This is a multi-center, randomized, third party blinded study of patients with previously treated stage I or IIA MF. Prior treatments may include topical therapies, but not topical NM or topical carmustine (BCNU). The patients will be either treated with topical NM 0.02% propylene glycol (gel) or topical NM 0.02% in an aquaphor ointment once daily. This study involves coming to the Stanford clinic every 4 weeks from months 1-6 and every 8 weeks from months 7-12. More »
Phase I/II Study of Intratumoral Injection of CpG 7909, A TLR 9 Agonist, Combined with Local Radiation for Patients with Low-Grade B-cell Lymphoma and Mycosis Fungoides
This is a single institution phase I/II trial to evaluate the safety and efficacy of intratumoral CpG injections with local radiation in patients with mycosis fungoides. Patients will receive low-dose radiotherapy to a single tumor site on days 1 and 2 (2 Gy each day). CpG injections will be administered at Stanford into the same tumor site within 24 hours before or 24 hours after each radiation treatment. Weekly doses of (intratumoral or peritumoral injections) CpG will be then administered subcutaneously in the region of previous injections for 23 additional doses. The treatment duration is 24 weeks. More »
A single agent Phase II study of depsipeptide (FK228) in the treatment of Cutaneous T-cell Lymphoma
Gloucester Pharmaceuticals, Inc. is sponsoring a Phase II trial of depsipeptide (FK228) in the treatment of patients with stage II, III, and IVA Cutaneous T-Cell Lymphoma. Depsipeptide is an infusional histone deacetylase inhibitor. All patients in this study will receive an infusion of depsipeptide on Days 1, 8, and 15 of each month for 6 months for a total of 18 infusions. If a patient chooses to participate, they will have blood tests (approx. 2.5 tablespoons) done at days 1,8,15, and 22 of each month. The patient will also have an electrocardiogram monitoring with each infusion. Each month, photographs will be taken of their body, front and back, as well as skin lesions. More »
Phase II Trial of CC-5013 (Revlimid®) in Patients with Cutaneous T-cell Lymphoma
This phase II trial involves treatment with an investigational drug called Revlimid®, also known as lenalidomide or CC-5013, for patients with relapsed mycosis fungoides/Sézary syndrome from stage IA to IVB. The study drug, Revlimid®, is a compound of a class of novel drugs that stimulates the immune system and prevents tumors from forming blood vessels. Patients must have failed at least one previous therapy to be considered for this trial. Study participants will take the study drug orally (by mouth) for 21 days with 7 days rest (no study drug). One study treatment cycle will consist of 28 days (4 weeks). Participants will receive at least 2 cycles of study treatment and possibly up to 24 cycles (2 years). Blood tests will be done weekly for the first 2 cycles, then monthly unless the study doctor feels it is necessary to do it more frequently. Also, photos will be taken, and physical exams and skin scoring will be done each visit. Females of childbearing potential will have periodic pregnancy tests. Patients can expect to have a biopsy done prior to entry into the trial, and if/when they exhibit a clinical response. More »
A Phase II Clinical Trial of PXD101 in Patients with Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas
This is a research study of an investigational study drug called PXD101, which is being tested for efficacy in patients with cutaneous T-cell lymphoma which has either not responded to standard therapy or which responded initially, but is no longer responding. The intravenous (IV) study drug will be given once a day for 30 minutes for 5 consecutive days, followed by 16 days of observation. This 21-day period of treatment and observation is defined as one treatment cycle. This study specifies that participants receive at least 2 cycles of treatment and up to 8 cycles of treatment depending on his/her response to the study drug. If the response is clinically important, participants may receive the drug for a longer period (up to 9 months) if the study doctor and the sponsor of the study agree. Females of childbearing potential will have a pregnancy test done, and all participants will have periodic laboratory tests done, and skin assessments will be done each study visit. More »
Phase II Clinical Trial of Intra-Lesional Administration of TG1042 (Adenovirus-Interferon-Gamma) in Patients with Relapsing Primary Cutaneous B-cell Lymphomas
This study is a phase II, multi-center trial sponsored by Transgene, S.A. of repeated intra-lesional administration of TG1042 in patients with relapsing primary cutaneous B-cell lymphomas. Patients must have failed radiotherapy or other standard therapy to be eligible for the trial. TG1042 will be injected in up to six lesions on days 1, 8, and 15 of each cycle. At the end of each cycle, or every 4 weeks, lesions will be measured and photographs will be taken. If there is no tumor progression or severe adverse effects, a new treatment cycle may be instituted up to a maximum of 4 cycles, or a total of 12 injection sessions. Following this treatment session, patients will be monitored on a monthly basis for the next six months, and then on a quarterly basis for one year. More »
