Melanoma 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.

(updated 12/03/2012)

Adjuvant

Pegylated Interferon + Peptide (2006-0816) Phase I (NCT00861406)
Principal Investigator: Wen-Jen Hwu, MD, PhD
Pegylated interferon is combined with the melanoma peptide vaccine, gp100, and may help improve an immune response to the vaccine. Patients must be free of disease after surgical resection for AJCC stage II or III (N1a) melanoma (T2b, T3a, T3b, T4a, T4b and N1a or N2a). Patients must be HLA-A0201 positive and have had surgical resection within 90 days.

Study of Biological Response to Dasatinib Treatment in Patients with Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma (2009-0447) Phase II (NCT01092728)
Principal Investigator: Kevin Kim, MD
Dasatinib is an oral agent that targets the KIT mutations seen in some melanomas. Patients with acral lentiginous, mucosal melanoma or melanoma of chronic sun-damaged skin. Patients at any stage with surgically resectable tumors or biopsiable tumors(s) are eligible.

Phase I/II Study of Ipilimumab for Uveal Melanoma (2011-0919) (NCT01585194)
Principal Investigator: Sapna P. Patel, MD
The goal of this clinical research study is to learn the highest tolerable dose of ipilimumab that can be given to patients with uveal melanoma. Researchers also want to learn if ipilimumab can help to control the disease. Ipilimumab is designed to increase the immune system's ability to fight cancer.

Neoadjuvant

N/A

Chemo-Naïve Patients (no previous chemotherapy)

Trial of High Dose Interleukin-2 (HDIL-2) with Recombinant MAGE-A3 Protein Combined with Adjuvant System AS15 in Patients with Unresectable or Metastatic Melanoma (2010-0113) Phase II (NCT01266603)
Principal Investigator: Wen-Jen Hwu, MD, PhD
The use of recombinant vaccines in combination with HDIL-2 may potentially increase response rates by stimulating the immune system. Patients with at least one biopsiable lesion and/or access to paraffin-embedded tissue block sample.

Patients with previous chemotherapy

T-Cells +/- Dendritic Cells (2004-0069) Phase II (NCT00338377)
Principal Investigator: Patrick Hwu, MD
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 easily be biopsied.

Activation of pDCs at tumor and vaccine sites with TLR agonist (2008-0416) Phase II (NCT00960752)
Principal Investigators: Patrick Hwu, MD and Richard Royal, MD
In this study, we are combining vaccines with a novel agent called resiquimod that can further stimulate the immune system. For patients with metastatic melanoma with measurable disease, Stage IIIC (in transit lesions) or Stage IV (M1A). Patients must be HLA-A201 and DP4 positive to participate and have at least 4 biopsiable lesions. No previous exposure to gp100 or MAGE-3 peptide.

TPI 287 in Combination with Temozolomide (2009-0357) Phase I/II (NCT01067066)
Principal Investigator: Agop Bedikian, MD
This study combines the cytotoxic agent Temozolomide with a novel microtubule inhibitor TPI287. Patients with unresectable Stage III or Stage IV, including bulky stage III and M1-3. Patients who have brain metastases must be off drugs for at least a week.

LOC-Paclitaxel (2009-0432) Phase I (NCT01039844)
Principal Investigator: Agop Bedikian, MD
LOC-paclitaxel is a taxane prepared with fatty acids to enhance the uptake of paclitaxel by the tumor achieving higher concentrations over a prolonged period. Patients who have failed all conventional therapies and no other therapies are available. No CNS metastases allowed.

Study of E7080 (2010-0356) Phase II (NCT01136967)
Principal Investigator: Kevin Kim, MD
E7080 is an oral agent that acts as a potent inhibitor of the split-kinase family of growth factors, exhibiting anti-angiogenic activity. Patients not previously treated with targeted therapy, measurable disease.

An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the BRAF Inhibitor GSK2118436 in Combination with the MEK Inhibitor GSK1120212 in Subjects with BRAF Mutant Metastatic Melanoma (2009-0949) (NCT01072175)
Principal Investigator: Kevin Kim, MD
The goal of this clinical research study is to find the highest tolerable dose of the drugs GSK2118436 and GSK1120212 that can be given together in patients with advanced solid cancer that has a BRAF mutation. The effects of the study drugs at different dose levels and the safety of the study drugs will also be studied.

Phase I Study of Single Agent MK-3475 in Patients with Progressive Locally Advanced or Metastatic Carcinomas, Melanoma and Non-Small Cell Lung Carcinoma (2011-0757) (NCT01295827)
Principal Investigator: Wen-Jen Hwu, MD, PhD
There are three parts to this clinical research study. The goal of Part A was to find the highest tolerable dose of MK-3475 that can be given to patients with any type of carcinoma or melanoma. MD Anderson will not be taking part in Part A. The goal of Part B is to further test the highest tolerable dose that was found in Part A when given to patients with melanoma. The safety of this drug will also be studied. The goal of Part C is to test the highest tolerable dose of MK-3475 that can be given to patients with non-small cell lung cancer (NSCLC.) MK-3475 is a drug that includes a protein naturally created by living cells. It is designed to help the body’s natural defense system react against tumors by blocking proteins that cancer cells create to “turn off” the body’s immune (defense) system. This is the first study using MK-3475 in humans.

An Open-Label Phase II Study of the Combination of GSK2118436 and GSK1120212 in Patients with Metastatic Melanoma which is Refractory or Resistant to BRAF Inhibitor (2011-0579) (NCT01619774)
Principal Investigator: Kevin B.Kim, MD
The goal of this clinical research study is to learn if the combination of two drugs (GSK2118436 and GSK1120212) can help to control melanoma. The safety of this drug combination will also be studied. GSK2118436 is designed to block the mutated BRAF protein. This mutation is only found in moles of the skin and in melanoma cells. By blocking the protein, the drug may slow the growth of or kill cancer cells that have the protein. GSK1120212 is designed to block certain proteins that cause cancer cells to grow and multiply. This may cause the cancer cells to die.

Phase I/II Study of the Combination of Doxycycline with Temozolomide and Ipilimumab in Patients with Metastatic Melanoma (2011-1165) (NCT01590082)
Principal Investigator: Kevin B. Kim, MD
The goal of this clinical research study is to find the highest tolerable dose of doxycycline that can be combined with temozolomide and ipilimumab in patients with advanced melanoma. The safety and level of effectiveness of the study drug combination will also be studied.

Patients with Metastatic Uveal Melanoma

Study of Genasense-Carboplatin-Paclitaxel-combination in Uveal Melanoma (2010-0188) Phase II (NCT01200342)
Principal Investigator: Sapna Patel, MD
The use of Genasense, a Bcl-2 antisense molecule in combination with cytotoxic agents Carboplatin and Paclitaxel is thought to have synergistic activity. Patients must have histologic or cytologic confirmation of malignant uveal melanoma and documented metastatic disease with measurable disease. Patients may have had previous treatment except hepatic chemoembolization is not allowed. Patients with brain metastases or history of brain metastases are not allowed.

Hepatic Arterial Infusion of Abraxane (2006-0603) Phase I (NCT00833807)
Principal Investigator: Agop Bedikian, MD
Nab-paclitaxel is administered via the hepatic artery to the liver, delivering a large dose of drug directly to the tumor with less systemic toxicity. Patients must have at least one clearly measurable metastatic lesion in the liver that is more than 2 cm in the largest dimension. Patients must not have received prior systemic chemotherapy with regimens including taxanes. Prior adjuvant treatment with immunotherapy or vaccine therapy is allowed provided there is documentation of disease progression in the liver.

Phase II Study of IMC-A12 in Metastatic Uveal Melanoma (2010-0451) (NCT01413191)
Principal Investigator: Sapna Patel, MD
The goal of this clinical research study is to learn if IMC-A12 can help control metastatic uveal melanoma. Researchers will study how IMC-A12 affects the levels of tumor markers, chemicals in the blood and tissue related to the growth and spread of cancer cells. Researchers will study the effects of the
study drug, good and/or bad, on the insulin-like growth factor-1 receptor (IGF-1R), a natural protein in the body that may be related to metastatic uveal melanoma. The safety of IMC-A12 will also be studied.