![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
|
Phase I/II Randomized Study of Vaccination Comprising MART-1/gp100/Tyrosinase/NY-ESO-1/MAGE-3 Peptide-Pulsed Dendritic Cells Matured Using Cytokines in Combination With Autologous Lymphocyte Infusion With or Without Fludarabine in Patients With Chemotherapy-Naïve Metastatic Melanoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Vaccine Therapy and Autologous Lymphocyte Infusion With or Without Fludarabine in Treating Patients With Metastatic Melanoma
Basic Trial Information
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
Phase
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
Type
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
Status
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
Age
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
Sponsor
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
Protocol IDs
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif)
Phase II, Phase I
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif)
Treatment
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif)
Active
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif)
16 and over
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif)
NCI
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif)
MCC-13649 LAC-USC-10M-05-2, 6241, NCI-6241, LAC-USC-HS-05-00068, NCT00313508
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
|
Objectives Primary - Assess the toxicity and immune responses in HLA-A*0201-positive patients with chemotherapy-naïve metastatic melanoma treated with either escalating doses of fludarabine or no fludarabine followed by autologous lymphocyte infusion and vaccination with dendritic cells matured ex vivo with a cytokine cocktail and pulsed with MART-1/gp100/tyrosinase/NY-ESO-1/MAGE-3 class I and II peptides.
Secondary - Compare clinical responses in patients receiving these regimens.
Entry Criteria Disease Characteristics:
- Diagnosis of metastatic melanoma
- The following subtypes are also eligible:
- Unresectable stage III or IV uveal melanoma
- Metastatic mucosal melanoma
- Measurable disease after attempted curative surgical therapy
- Tumor tissue must be available for immunohistochemical staining
- Positive for ≥ 1 of the following peptides:
- MART-1
- Tyrosinase
- NY-ESO-1
- HMB-45
- HLA-A *0201 positive
- Positive for DR4 and/or DP4 by DNA SSOP analysis
Prior/Concurrent Therapy:
- See Disease Characteristics
- No prior chemotherapy
- Prior adjuvant interferon or isolated limb perfusion allowed
- More than 1 month since prior and no other concurrent therapy for melanoma, including radiotherapy, chemotherapy, or adjuvant therapy
- At least 1 month since prior surgery
- No concurrent steroid therapy
- No prior gp100 209-217 (210M), MART-1 26-35 (27L), gp100 280-288 (288V), tyrosinase 207-215, or NY-ESO-1 157-165 (165V) peptides
Patient Characteristics:
- ECOG performance status 0 or 1
- WBC ≥ 3,000/mm3
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100,000/mm3
- Bilirubin ≤ 2.0 mg/dL
- ALT/AST < 3 times upper limit of normal
- Creatinine ≤ 2.0 mg/dL
- Seropositive for Epstein-Barr virus
- No major systemic infections
- No coagulation disorders
- No documented myocardial infarction in the past 6 months
- No other major medical illnesses of the cardiovascular or respiratory systems
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known positivity for hepatitis B surface antigen or hepatitis C antibody
- No known HIV positivity
- No prior uveitis or autoimmune inflammatory eye disease
- No other malignancy except for cervical carcinoma in situ or basal cell or squamous cell skin cancer unless patient was curatively treated > 5 years ago and has no detectable disease
- No history of any of the following:
- Hypogammaglobulinemia
- Lymphocytopenia
- Impaired immune response
- Tuberculosis or positive PPD unless patient received prior bacilli Calmette-Guérin vaccine (BCG)
Expected Enrollment 48A total of 48 patients will be accrued for this study. Outcomes Primary Outcome(s)Overall survival Progression-free survival Time to progression
Secondary Outcome(s)Immunological response in patients receiving MART-1/gp100/tyrosinase/NY-ESO-1 with fludarabine Toxicity of MART-1/gp100/tyrosinase/NY-ESO-1 with fludarabine
Outline This is a randomized, controlled, multicenter, dose-escalation study of fludarabine. Patients are randomized to 1 of 2 treatment arms. All patients undergo two apheresis procedures, one to collect lymphocytes for the autologous lymphocyte infusion and one to collect dendritic cells (DC) for the production of the autologous vaccine. Autologous DC are pulsed with tumor antigen class I and II peptides derived from MART-1, gp100, tyrosinase, NY-ESO-1, and MAGE-3 and matured with a cytokine cocktail comprising tumor necrosis factor-α, interleukin (IL)-6, IL-1β, and prostaglandin E2. After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Trial Contact Information
Trial Lead Organizations H. Lee Moffitt Cancer Center and Research Institute at University of South Florida ![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) | Jeffrey Weber, MD, PhD, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) | Ph: 813-745-4261; 888-663-3488 |
| ![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) | Trial Sites
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
U.S.A. |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
Florida |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
|
Tampa |
![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) |
| | | | | | | | H. Lee Moffitt Cancer Center and Research Institute at University of South Florida |
| | Clinical Trials Office - H. Lee Moffitt Cancer Center and Reseach Institute | |
| Email:
canceranswers@moffitt.org |
|
Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | A Dose Ranging Trial of MART-1/gp100/Tyrosinase/NY-ESO-1 Peptide-Pulsed Dendritic Cells Matured Using Cytokines with Autologous Lymphocyte Infusion With or Without Escalating Doses of Fludarabine for Patients With Chemotherapy-naive Metastatic Melanoma | ![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2006-02-01 | ![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) | Trial Completion Date | | 2009-03-02 (estimated) | ![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00313508 | ![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2005-12-22 | ![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2008-04-10 | ![](https://webarchive.library.unt.edu/eot2008/20081020131005im_/http://www.cancer.gov/images/spacer.gif) | NCI Grant/Contract Number | | CA14089, CA105139, CA76292 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
![](images/spacer.gif) |