- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00019396
flt3L With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma or Renal Cell Cancer
Phase II Study of Flt3 Ligand Alone or in Combination With Melanoma Peptide Immunization in Patients With Metastatic Melanoma or Renal Cell Cancer
RATIONALE: The drug flt3L may stimulate a person's immune system and help to kill tumor cells. Vaccines made from melanoma cells may make the body build an immune response to and kill their tumor cells.
PURPOSE: Phase II trial to study the effectiveness of flt3L with or without vaccine therapy in treating patients with metastatic melanoma or renal cell cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Evaluate the immunologic and biologic activity of flt3 ligand (Flt3L) alone in patients with metastatic renal cell cancer or HLA-A2.1 negative melanoma.
II. Evaluate the immunologic and biologic activity of Flt3L alone or in combination with melanoma peptide immunization (MART-1, gp100:209-217, gp100:280-288, and tyrosinase) in patients with metastatic, HLA-A2.1 positive melanoma.
PROTOCOL OUTLINE: Patients are assigned to 1 of 3 treatment groups:
Group 1 (renal cell cancer): Patients receive Flt3 ligand (Flt3L) subcutaneously (SQ) alone on days 1-14.
Group 2 (HLA-A2.1 negative melanoma): Patients receive Flt3L SQ alone on days 1-14.
Group 3 (HLA-A2.1 positive melanoma): Patients may receive either Flt3L SQ alone on days 1-14 or in combination with melanoma peptide immunization. Patients may receive melanoma peptide immunization comprised of MART-1 immunodominant peptide, gp100:209-217, gp100:280-288, and tyrosinase peptide emulsified in Montanide ISA-51 SQ on day 12 of Flt3L administration.
Treatment repeats every 4 weeks for 2 courses. Patients with no response or minor response may receive 2 additional courses. Patients with disease progression after 1 course are removed from study.
PROJECTED ACCRUAL:
Approximately 54-96 patients (18-32 per treatment group) will be accrued for this study within 16 months.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Surgery Branch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically proven metastatic melanoma or renal cell cancer Patients receiving melanoma peptide immunizations must be HLA-A2.1 positive Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: At least 1 month since prior biologic therapy Chemotherapy: At least 1 month since prior chemotherapy Endocrine therapy: No concurrent systemic steroid therapy At least 1 month since prior steroid therapy Radiotherapy: At least 1 month since prior radiotherapy Surgery: Prior surgery allowed Other: Greater than 1 month since prior therapy --Patient Characteristics-- Age: Not specified Performance Status: ECOG 0-1 Life Expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorders Hepatic: Bilirubin no greater than 1.6 mg/dL AST and ALT less than 2 times normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No major cardiovascular disease Pulmonary: No major pulmonary disease Other: Not pregnant or nursing Negative pregnancy test HIV negative Hepatitis B surface antigen negative No allergic reaction to Montanide ISA-51 No active systemic infection No prior autoimmune disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Patrick Hwu, National Cancer Institute (NCI)
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Kidney Neoplasms
- Neuroendocrine Tumors
- Nevi and Melanomas
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Recurrence
- Melanoma
- Physiological Effects of Drugs
- Immunologic Factors
- Protective Agents
- Adjuvants, Immunologic
- Radiation-Protective Agents
- Monatide (IMS 3015)
- Flt3 ligand protein
Other Study ID Numbers
- CDR0000065997
- NCI-98-C-0040
- NCI-T97-0092
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Melanoma
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Uveal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Recurrent Intraocular Melanoma | Extraocular Extension MelanomaCanada, United States
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Recurrent Intraocular Melanoma | Extraocular Extension MelanomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingMetastatic Cutaneous Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Recurrent Cutaneous Melanoma | Clinical Stage IV Cutaneous Melanoma AJCC v8 | Recurrent Mucosal Melanoma | Metastatic Mucosal Melanoma | Non-Cutaneous Melanoma | Metastatic Non-Cutaneous Melanoma | Recurrent Non-Cutaneous...United States, Canada, Ireland
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage III Melanoma | Extraocular Extension MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); Incyte Corporation; University of VirginiaCompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Mucosal Melanoma | Stage IV Uveal Melanoma | Stage IIIA Skin Melanoma | Stage IIIA Uveal Melanoma | Stage IIIB Uveal Melanoma | Stage IIIC Uveal Melanoma | Recurrent Uveal MelanomaUnited States
-
National Cancer Institute (NCI)M.D. Anderson Cancer CenterWithdrawnSorafenib and Temsirolimus in Treating Patients With Metastatic, Recurrent, or Unresectable MelanomaMelanoma | Recurrent Melanoma | Stage IV Melanoma | Stage III Melanoma
-
Fred Hutchinson Cancer CenterAmazon.com Services LLCRecruitingAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Metastatic Cutaneous Melanoma | Unresectable Cutaneous Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Pathologic Stage IIID Cutaneous Melanoma AJCC... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Metastatic Melanoma | Stage III Cutaneous Melanoma AJCC v7 | Stage IV Cutaneous Melanoma AJCC v6 and v7 | Refractory Malignant Solid Neoplasm | Recurrent Melanoma | Recurrent Malignant Solid Neoplasm | Recurrent Neuroblastoma | Recurrent Non-Hodgkin... and other conditionsUnited States, Canada
Clinical Trials on flt3 ligand
-
National Cancer Institute (NCI)CompletedKidney Cancer | Melanoma (Skin)United States
-
Eastern Cooperative Oncology GroupNational Cancer Institute (NCI); Southwest Oncology Group; Cancer and Leukemia...Completed
-
Duke UniversityNational Cancer Institute (NCI)CompletedColorectal Cancer | Metastatic CancerUnited States
-
Albert Einstein College of MedicineCelldex TherapeuticsCompletedNon-small Cell Lung Cancer (NSCLC)United States
-
Albert Einstein College of MedicineCelldex TherapeuticsTerminatedLung Cancer | Non Small Cell Lung CancerUnited States
-
Northwestern UniversityCompletedLymphoma | Leukemia | Breast Cancer | Multiple Myeloma and Plasma Cell Neoplasm | Myelodysplastic/Myeloproliferative DiseasesUnited States
-
National Cancer Institute (NCI)CompletedMelanoma | Stage III Cutaneous Melanoma AJCC v7 | Stage IV Cutaneous Melanoma AJCC v6 and v7 | Ocular Melanoma | Stage IIIC Cutaneous Melanoma AJCC v7 | Melanoma of Unknown Primary | Cutaneous Melanoma | Mucosal Melanoma | Stage IIIA Cutaneous Melanoma AJCC v7 | Stage IIIB Cutaneous Melanoma AJCC v7 | Stage... and other conditionsUnited States
-
Northwestern UniversityNational Cancer Institute (NCI)TerminatedLymphoma | NeutropeniaUnited States
-
University of Southern CaliforniaRecruitingSoft Tissue Sarcoma | Anatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Metastatic Melanoma | Merkel Cell Carcinoma | Unresectable Melanoma | Unresectable Breast Carcinoma | Bone Sarcoma | Sarcoma,Soft Tissue | Metastatic Breast Carcinoma | Cutaneous Squamous Cell Carcinoma and other conditionsUnited States
-
The First Affiliated Hospital of Soochow UniversityThe First Affiliated Hospital with Nanjing Medical University; The Affiliated... and other collaboratorsRecruitingAcute Myeloid LeukemiaChina