Clinical Trials

For more information on these clinical trials, call the Information Line toll-free at 1-800-392-1611, or the Melanoma and Skin Center New Patient Referral at (713) 563-9716.

Currently Active Melanoma Oncology Clinical Trials
(updated 01/21/2009)

Adjuvant

Leuprolide + Peptide vaccine (2004-0502) Phase II
Principal Investigator: Dr. Patrick Hwu
Research Nurse: Priscilla Miller, R.N.
This study tests if sex hormone blockade will result in enhanced thymic activity in melanoma patients that will lead to improved anti-tumor T-cell responses following antigen-specific immunization. Patients will be randomized to receive different combinations of gp100, MAGE-3, and Leuprolide vaccine. Patients must be HLA-A2+, and have no history of immunization with gp100 or MAGE-3 vaccines.

ECOG1697 Phase III
Principal Investigator: Dr. Homsi
Research Nurse: Suzanne Cain, R.N.
Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2b No, T3a-b, T4a-b No, and T1-4, N1a, 2a, 3 (microscopic) Melanoma. Patients with melanoma of a cutaneous origin are eligible for this study. Patients are also eligible who have declined 1 year of interferon.

Neoadjuvant

Temozolomide alone or with Pegylated interferon-alpha 2b (2005-0143) Phase II
Principal Investigator: Dr. Wen-Jen Hwu
Research Nurse: Suzanne Cain, R.N.
Temozolomide is a drug that is designed to work by stopping cancer cells from making new DNA. Pegylated Interferon Alpha-2b is a protein made by the human immune system that helps to fight viral infections regulate cell function. Patient may not have had any prior systemic chemotherapy.

Chemo-naïve patients (no previous chemotherapy)

Biochemotherapy with Temozolomide (DM03-0218) Phase II
Principal Investigator: Dr. Nicholas Papadopoulos
Research Nurse: Suzanne Cain, R.N.
Concurrent biochemotherapy with cisplatin, velban, IL-2, interferon alfa, temozolomide, and thalidomide. Temozolomide has been shown to induce regression of brain metastases. Thalidomide may enhance the anti-tumor activity & decrease the toxicity of the biochemotherapy via a number of mechanisms.

DTIC +/- Genasense (2007-0361) Phase III
Principal Investigator: Dr. Agop Bedikian
Research Nurse: Karen Woodard, R.N.
This study is designed to administer Dacarbazine, plus or minus a Bcl-2 antisense therapy. Antisense therapy involves the administration of synthetic oligonucleotides that are complementary to specific mRNA transcripts, and then RNAse H cleaves the bcl-2 mRNA strand, rendering the message nontranslatable.

Chemo-naïve patients OR patients with no previous chemotherapy

BAY43-9006 (Sorafinib) + CCI-779 (Temsirolimus) (2005-0215) Phase I/II
Principal Investigator: Dr. Kevin Kim
Research Nurse: Karen Woodard, R.N.
BAY43-9006 is an inhibitor of C-Raf, B-Raf, VEGFR and PDGFR, and CCI-779 is an inhibitor of mTOR. Whether inhibiting two of the commonly activated signal pathways in melanoma leads to better clinical outcome will be studied. Patients must have easily biopsiable tumor (skin, SQ, superficial lymph nodes) to enroll.

T-cells +/- dendritic cells (2004-0069) Phase II
Principal Investigator: Dr. Patrick Hwu
Research Nurse: Priscilla Miller, R.N.
In this study, T-cells capable of recognizing and killing melanoma will be isolated from tumor biopsies and expanded in the laboratory. The T-cells will then be reinfused into the patients with or without dendritic cells, which are immune cells capable of potently activating T-cells. This study is for patients with a good performance status, with measurable metastatic melanoma, and a site that can be easily biopsied.

Temodar + Thalidomide + CCNU (2004-0595) Phase I/II
Principal Investigator: Dr. Nicholas Papadopoulos
Research Nurse: Suzanne Cain, R.N.
Temozolomide, Lomustine and Thalidomide will be combined as a therapeutic agent. Temozolomide has shown activity against CNS metastases, and Thalidomide is an antiangiogenic agent. Lomustine, an oral nitrosorea, has activity against disseminated melanoma. This study is for patients with brain metastases.

CRO11-vcMME (2006-0378) Phase I
Principal Investigator: Dr. Patrick Hwu
Research Nurse: Deborah Sanders, R.N.
CRO11-vcMME potently inhibits the growth of a variety of melanoma cell lines in vitro by binding to cell surface Glycoprotein NMB. Patients must have unresectable stage III or stage IV melanoma.

CHIR-265 (2005-0949) Phase I/II
Principal Investigator: Dr. Kevin Kim
Research Nurse: Cora Cheung, R.N.
RAF265 is a novel small molecule with potent inhibitory activity against mutant B-Raf kinase, VEGFR-2 and also to a lesser degree, PDGF-alpha, and c-kit.

Decitabine and PEG Intron (2007-0450) Phase I/II
Principal Investigator: Wen-Jen Hwu, M.D.
Research Nurse: Ingrid Hernandez, R.N.
Determine the safety and tolerability of the combination of drugs at 6 pre-determined dose levels in patients with advanced melanoma. Also to determine clinical benefit and to determine progression-free survival. Patients may have one prior chemotherapy.

PLX06-02 (2007-0088) Phase I
Principal Investigator: Dr. Kevin Kim
Research Nurse: Deborah Sanders, R.N.
This study will Provide an assessment of the safety, tolerability, pharmacokinetics, and pharmacodynamics activity of ascending doses of PLX4032. This is the first assessment of PLX4032 in patients with solid tumors.

AZD6422 and DTIC (2008-0499) Phase I
Principal Investigator: Kevin Kim, MD
Research Nurse: Sandy Mahoney, RN
This study is therefore designed to investigate the twice daily dosing of AZD6244, a MEK inhibitor, in combination with standard chemotherapies in patients with advanced solid tumors. This study will evaluate the safety profile, tolerability, and PK of AZD6244 in combination with 4 standard chemotherapies and support subsequent testing in Phase II.

Metastatic Choroidal Melanoma

PLX06-02 (2007-0088) Phase I
Principal Investigator: Dr. Kevin Kim
Research Nurse: Deborah Sanders, R.N.
This study will provide an assessment of the safety, tolerability, pharmacokinetics, and pharmacodynamics activity of ascending doses of PLX4032. This is the first assessment of PLX4032 in patients with solid tumors.

AZD6422 and DTIC (2008-0499) Phase I
Principal Investigator: Kevin Kim, MD
Research Nurse: Sandy Mahoney, RN
This study is therefore designed to investigate the twice daily dosing of AZD6244, a MEK inhibitor, in combination with standard chemotherapies in patients with advanced solid tumors. This study will evaluate the safety profile, tolerability, and PK of AZD6244 in combination with 4
standard chemotherapies and support subsequent testing in Phase II.

Brain Metastases

Temodar + Thalidomide + CCNU (2004-0595) Phase II
Principal Investigator: Dr. Nicholas Papadopoulos
Research Nurse: Suzanne Cain, R.N.
Temozolomide, Lomustine and Thalidomide will be combined as a therapeutic agent. Temozolomide has shown activity against CNS metastases, and Thalidomide is an antiangiogenic agent. Lomustine, an oral nitrosorea, has activity against disseminated melanoma. This study is for patients with brain metastases.

MPC (2007-0445) Phase I
Principal Investigator: Dr. Wen-Jen Hwu
Research Nurse: Deborah Sanders, R.N.
Dose Finding Phase I Study of the Treatment of Melanoma Metastatic to Brain with MPC-6827 in Combination with Temozolomide. This protocol is for patients to determine the MTD (up to a maximum dose of 3.3 mg/m2) of MPC-6827 in combination with an extended dosing regimen of temozolomide.

Laboratory Protocols

Biomarkers of high dose IL-2 responsiveness (LAB06-0762)
Principal Investigator: Dr. Laszlo Radvanyi
Research Nurse: Deborah Sanders, R.N.
Interleukin-2 (IL-2) therapy has been used extensively over the past fifteen years to effectively treat patients with advanced metastatic melanoma and renal cell carcinoma. This study will aide to map out a complete picture of what IL-2 is doing in the PBMC and tumor site in melanoma patients. Patients must receive high dose IL-2 in order to qualify for this study.

Blood & Tumor Sample Collection for Long Term Storage (2005-0466)
Principal Investigator: Dr. Kevin Kim
Research Nurse: Karen Woodard, R.N.
This study will collect blood and tumor samples from patients with suspected or confirmed melanoma and place these samples in long-term storage for future biological and/or surrogate marker studies.