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Below are current clinical trials listed by the state of the principle investigator. The list may not include every trial that is available. Some clinical trials are multi-center trials and may be available in more than the one state of the listed principle investigator. You should check with your physician to see if the trial is multi-center.
Louisiana: New Orleans
Oklahoma: Tulsa
Texas: Dallas
Texas: Houston
Texas: Temple
LOUISIANA: NEW ORLEANS
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome
PURPOSE: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent
Exclusion Criteria:
* Prior treatment with combination chemotherapy within four weeks
* Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
* Serious intercurrent medical condition
* Acute or chronic infectious disease.
* Patient with a history of intermittent relapsing herpes simplex skin affections on prophylactic treatment with acyclovir and valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus maybe included.
* Breast feeding women or women with a positive pregnancy test
* Patients of childbearing potential must practice adequate contraception
CONTACT:
Zena Muzyczenko
1-866-887-1291
mf@us.genmab.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881
OKLAHOMA: TULSA
If you have previously treated mycosis fungoides, but have not used topical nitrogen mustard within the last 2 years, you may be eligible for this trial
University of Oklahoma is currently is looking for subjects to participate in a research study of a topical investigational drug for patients with mycosis fungoides.
This is a 12-month study. Study drug and procedures will be made available to you at no cost.
To qualify you must:
• Be diagnosed with mycosis fungoides stage I – IIA
• Have not been treated with nitrogen mustard in the last two years
• Not be pregnant or nursing
• Not have had radiation therapy within one year of study start
• Be free of other serious illness
CONTACT INFORMATION:
University of Oklahoma
Tulsa, OK 74135
Principal Investigator: Mark F. Naylor, M.D.
PH: 918-743-6675
mark-naylor@ouhsc.edu
Coordinator: Lisa Perry, MA
P: 918-619-4466
Lisa-perry@ouhsc.edu
ClinicalTrials.gov identifier: NCT00168064
TEXAS: DALLAS
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome
PURPOSE: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent
Exclusion Criteria:
* Prior treatment with combination chemotherapy within four weeks
* Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
* Serious intercurrent medical condition
* Acute or chronic infectious disease.
* Patient with a history of intermittent relapsing herpes simplex skin affections on prophylactic treatment with acyclovir and valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus maybe included.
* Breast feeding women or women with a positive pregnancy test
* Patients of childbearing potential must practice adequate contraception
CONTACT:
Zena Muzyczenko
1-866-887-1291
mf@us.genmab.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881
TEXAS: DALLAS
If you have previously treated mycosis fungoides, but have not used topical nitrogen mustard within the last 2 years, you may be eligible for this trial
UT Southwestern Medical Center at Dallas is currently is looking for subjects to participate in a research study of a topical investigational drug for patients with mycosis fungoides.
This is a 12-month study. Study drug and procedures will be made available to you at no cost.
To qualify you must:
• Be diagnosed with mycosis fungoides stage I – IIA
• Have not been treated with nitrogen mustard in the last two years
• Not be pregnant or nursing
• Not have had radiation therapy within one year of study start
• Be free of other serious illness
CONTACT INFORMATION:
UT Southwestern Medical Center at Dallas
Dermatology Clinical Trials
Dallas, TX 75390-8802
Principal Investigator: Amit Pandya, M.D.
P: 214-648-5770
Amit.pandya@UTsouthwestern.edu
Study Coordinator: Christina Carrigan, R.N.
P: 214-645-8968
Christina.Carrigan@UTsouthwestern.edu
ClinicalTrials.gov identifier: NCT00168064
TEXAS: HOUSTON
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome
PURPOSE: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent
Exclusion Criteria:
* Prior treatment with combination chemotherapy within four weeks
* Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
* Serious intercurrent medical condition
* Acute or chronic infectious disease.
* Patient with a history of intermittent relapsing herpes simplex skin affections on prophylactic treatment with acyclovir and valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus maybe included.
* Breast feeding women or women with a positive pregnancy test
* Patients of childbearing potential must practice adequate contraception
CONTACT:
Zena Muzyczenko
1-866-887-1291
mf@us.genmab.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881
TEXAS: HOUSTON
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Jennifer Edmondson, 919-859-7912
Mary Bordeaux, 843-545-8888
TEXAS: HOUSTON
Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-Cell Lymphoma
PURPOSE: The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL.
Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.
INCLUSION:
Primary CBCL including (according to WHO/EORTC classification 2005) :
* Primary cutaneous marginal zone B-cell lymphoma
* Primary cutaneous follicle center B-cell lymphoma
* Primary cutaneous diffuse large B-cell other than leg type
* See full description for further inclusion details
EXCLUSION:
* Primary cutaneous diffuse large B-cell lymphoma, leg type.
* Primary cutaneous intravascular large B-cell lymphoma.
* Extracutaneous involvement (sign of B-cell lymphoma on thoraco-abdominal CT scan and/or PET scan and/or on bone marrow biopsy).
* No histologic documentation of CBCL.
* History of known Human Immuno-deficiency Virus, Human Hepatitis B or C positive serology or other active systemic infections.
* Serious uncontrolled, concomitant medical disorders.
* Concomitant therapy for CBCL: surgical resection, radiotherapy, corticosteroid, chemotherapy, rituximab…(not limited listing)
* Major surgery in previous 4 weeks preceding the 1st injection.
* Pregnancy at study entry or who become pregnant during the study or women who are breast feeding.
* Males and females of reproductive potential who refuse to use adequate protection against pregnancy (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide) during the conduct of the study and for three months after the last injection.
* Participation in another experimental protocol during the study period and within 4 weeks prior to the first injection.
* Patient previously included in this study.
* Non compliance with the study.
Sponsor: Transgene
Identifier for www.clinicaltrials.gov: NCT00394693
CONTACT
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: Madeleine DUVIC, M.D. 713-745-1113 mduvic@mdanderson.org
Principal Investigator: Madeleine DUVIC, M.D.
TEXAS: HOUSTON
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
Madeleine Duvic, MD
1515
Holcombe Boulevard, Bldg 434
Houston, TX 77030-4009
Phone: (713) 745-1113
Fax: (713) 745-3812
Email: mduvic@mdanderson.org
Carol Wilson, RN
1515 Holcombe Boulevard, Bldg 434
Houston, TX 77030-4009
Phone: (713) 563-4655
Fax: (713) 745-3597
Email: cwilson@mdanderson.org
TEXAS: HOUSTON
If you have previously treated mycosis fungoides, but have not used topical nitrogen mustard within the last 2 years, you may be eligible for this trial
University of Texas MD Anderson Cancer Center is currently is looking for subjects to participate in a research study of a topical investigational drug for patients with mycosis fungoides.
This is a 12-month study. Study drug and procedures will be made available to you at no cost.
To qualify you must:
• Be diagnosed with mycosis fungoides stage I – IIA
• Have not been treated with nitrogen mustard in the last two years
• Not be pregnant or nursing
• Not have had radiation therapy within one year of study start
• Be free of other serious illness
CONTACT INFORMATION:
University of Texas MD Anderson Center
Houston, TX 77030
Principal Investigator: Madeleine Duvic, M.D.
PH: 713-745-4615
mduvic@mdanderson.org
Coordinator: Carol Wilson, RN
P: 713-563-4655
Clwilson@mdanderson.org
ClinicalTrials.gov identifier: NCT00168064
TEXAS: HOUSTON
A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas
The purpose of this open-label, non-randomized trial is to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Various members of this class of drugs have shown activity in preclinical studies and in initial clinical trials of multiple myeloma and lymphoma.
Eligibility
Ages Eligible for Study: 18 Years and above
Genders Eligible for Study: Both
Inclusion Criteria:
* Male or female with age > or = to 18 years.
* A histologically confirmed diagnosis of CTCL or PTCL or other T-cell NHL.
* Patients must have failed at least one line of prior systemic therapy, and there is no limitation in number of prior therapies. CTCL patients who are refractory or intolerant to oral Targretin are also eligible.
* The presence of measurable disease (defined as > or = to 1 cm with radiographic imaging) for PTCL or stage IB or greater disease for CTCL and assessable by the severity-weighted assessment tool (SWAT).
* Patients must have had a chest x-ray, CT scan or CT/PET scan or SWAT assessment within 2 weeks prior to enrollment for the CTCL patients or within 4 weeks prior to enrollment for PTCL patients and after completion of any prior cytotoxic chemotherapy. Patients with a history of bone marrow involvement must have a bone marrow biopsy within 4 weeks of study enrollment.
* Adequate bone marrow and hepatic function including the following:
* (a) WBC > or = to 3,000 cells/mm3, absolute neutrophil count > or = to 1,500 cells/mm3, platelets > or = to 50,000/mm3
* (b) Total bilirubin < or = to 1.5 x upper normal limit.
* (c) AST (SGOT), ALT (SGPT) and alkaline phosphatase < or = to 2.5 x upper normal limit
* (d) Hemoglobin > or = 9.0 g/dL.
* Serum potassium within normal range.
* Karnofsky performance status > or = to 70%.
* Estimated life expectancy > 3 months.
* Signed informed consent approved by the IRB.
Exclusion Criteria:
* Patients who have received anticancer therapies within 4 weeks of first PXD101 administration should be excluded unless toxicity from prior anticancer therapy has resolved or returned to baseline and cancer disease status warrants.
* Any use of investigational drugs within 4 weeks prior to study registration.
* Major surgery within 4 weeks of study drug administration.
* Prior allogenic bone marrow transplant.
* A diagnosis of Adult T-cell lymphone/leukemia (ATLL) or Precursor T-lymphoblastic lymphoma.
* Co-existing active infection or any co-existing medical condition likely to interfere with trial procedures. However, patients with progressing CTCL whose open skin lesions are frequently infected may not be excluded from this trial at the discretion of Investigators.
* Clinically significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, and congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months or a Left Ventricular Ejection Fraction < 40% (by ECHO or MUGA) within 3 months of study enrollment.
* A marked baseline prolongation of QT/QTc interval.
* Patients with renal insufficiency defined as a calculated creatinine clearance of <45 mL/min/1.73 m2.
* Patients with a history of allergic reactions attributed to compounds of similar chemical or biological composition to PXD101 and L-arginine.
* Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.
* Patients requiring treatment for other malignant diseases or less than 5 years post-treatment completion for an invasive malignant disease (excluding non-melanotic skin cancers or cervical cancer in-situ). Patients with any history of melanoma should be excluded.
* Pregnant or breast-feeding women, and women of childbearing age and potential, who are not willing to use effective contraception. Male patients and/or their fertile female partners who are not willing to use contraceptives during the trial.
* Known infection with HIV, HTLV-1, hepatitis B or hepatitis C.
CONTACT:
Houston, Texas, 77030, United States
Call for Information 877-462-4363
info@curagen.com
TEXAS: HOUSTON
Private Designer Vaccine? Consider Photopheresis
Photopheresis is an effective therapy for patients with blood involvement or Sézary Syndrome and is FDA approved for the treatment of CTCL. Photopheresis was first used by Dr. Richard Edelson and gave dramatic results in erythrodermic patients. Photopheresis combines a drug (psoralen or UVADEX), ultraviolet light, and the process of apheresis (removing blood cells). White blood cells are collected from the patient, treated with the drug, radiated with light, and then returned to the patient's blood circulation. The treated white blood cells are then thought to be presented to the patient's immune system inducing a vaccination against their malignancy, which is specific for each patient.
Early MF patients occasionally have blood involvement detected on flow cytometry, a sensitive test that can pick up malignant clones early. Therakos, Inc. has initiated a multicenter trial for patients with early disease who may have a small amount of abnormal cells in their blood. The trial will include up to 50 patients with Stage IA to IIA MF. Patients will be treated with photopheresis two days per month for up to six months and continue on trial if the photopheresis therapy is working.
CONTACT INFORMATION:
Madeleine Duvic, MD
Department of Dermatology - MD Anderson Cancer Center
1515 Holcombe Blvd. Unit 434
Houston, TX 77030
Phone: 713-794-1450 (Olga for direct calls) or 713-745-4615 (Lisa for department calls)
Fax: 713-745-3597
Study Coordinator: Carol Wilson, RN, or R. Talpur, MD 713-792-4578
TEXAS: TEMPLE
A Phase I/II study of A-dmDT390-bisFv(UCHT1) Fusion Protein in Patients with Cutaneous T-Cell Lymphoma
Physicians are currently seeking subjects to participate in this open-label, dose-escalation research study of an investigational agent. Eligible subjects will be hospitalized for 5 days. The investigational agent will be administered twice daily intravenously for four days. Subjects will then be monitored daily on an outpatient basis for a total of 10 additional days with a 30 day follow-up evaluation. Subjects with partial or complete remissions will have another follow-up visit on day 60, then every three months for 1 year, followed by annual visits to assess duration of the response. Approximately 30 patients will be enrolled in this study over two years.
Qualified subjects receive all evaluations and procedures related to the study at no cost, including physical examinations, laboratory tests, ECG and CT-scan. Blood draws and biopsies will be done periodically. Accommodations will be provided.
Inclusion Criteria includes:
• Age ≥ 18
• Diagnosis of T-cell Lymphoma
• Must be relapsed or refractory after receiving at least one prior topical or conventional therapy
• Patients must have CD3 on tumor cells
• No serious concurrent medical conditions, CNS disease, uncontrolled infections, MI in the last 6 months, or disseminated intravascular coagulopathy (DIC)
• Written informed consent
CONTACT INFORMATION:
Cancer Research Institute
Scott & White
5701 South Airport Rd
Temple, TX 76508
254.724.0040
Arthur Frankel, MD, Principal Investigator
254.724.0094
254.718.0781 (cell)
