- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004022
Biological Therapy Following Surgery in Treating Patients With Stage III or Stage IV Melanoma
Immunotherapy for Malignant Melanoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery in treating patients who have stage III or stage IV melanoma.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Evaluate the efficacy of immunotherapy with irradiated autologous tumor cell vaccine and sargramostim (GM-CSF) followed by monoclonal antibody OKT3- activated T lymphocytes and interleukin-2 in combination with surgery in terms of response rate in patients with stage III or IV malignant melanoma.
- Determine the immunogenicity of malignant melanoma in this patient population.
OUTLINE: Patients are stratified according to extent of disease, extent of antigen specific response to vaccination, performance status (0 vs 1), prior therapy (yes vs no), and gender.
Patients undergo surgical resection of tumor on week 1. Within 1-2 weeks of surgery, patients are vaccinated with irradiated autologous tumor cells and sargramostim (GM-CSF), then receive GM-CSF alone intradermally at vaccination sites daily for 4 days. Patients are revaccinated 2 weeks later.
Patients undergo peripheral blood mononuclear cell collection two weeks after the second vaccination. Peripheral blood mononuclear cells are stimulated with anti-CD3 monoclonal antibody (OKT3) and interleukin-2, producing activated T lymphocytes. The activated T lymphocytes are infused IV over 1-6 hours followed by 5 doses of interleukin-2 IV every other day over 10 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients may receive one additional course of immunotherapy as above.
Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Michigan
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically proven stage III or IV malignant melanoma
- Resectable disease
- At least 50,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- SWOG 0 or 1
Life expectancy:
- At least 6 months
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least lower limit of normal
- No active or recent uncontrolled bleeding
Hepatic:
- Bilirubin normal
- SGOT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)
Renal:
- Creatinine normal
Other:
- Negative stool guaiac
- No impaired immunity
- No uncontrolled diabetes
- No active uncontrolled infections
- No other serious disease
- No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- At least 2 weeks since prior therapy and recovered
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Roy D. Baynes, MD, PhD, FACP, Barbara Ann Karmanos Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Aldesleukin
- Muromonab-CD3
Other Study ID Numbers
- CDR0000067241
- P30CA022453 (U.S. NIH Grant/Contract)
- WSU-C-1403-ME
- NCI-G99-1565
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 Melanoma (Skin)
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
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William CarsonSchering-PloughCompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
-
National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
-
Roswell Park Cancer InstituteCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IB Skin MelanomaUnited States
-
Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
-
National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Mucosal Melanoma | Stage IIIA Skin MelanomaUnited States, Australia
-
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)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
Clinical Trials on aldesleukin
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National Cancer Institute (NCI)CompletedMetastatic Melanoma | Renal Cell CancerUnited States
-
Cancer Biotherapy Research GroupUnknownKidney CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Blumenthal Cancer Center at Carolinas Medical CenterUnknown
-
Northwestern UniversityNational Cancer Institute (NCI)Terminated
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI); Chiron CorporationCompleted
-
Blumenthal Cancer Center at Carolinas Medical CenterUnknown
-
Cancer Biotherapy Research GroupUnknownLung CancerUnited States
-
St. Anna KinderkrebsforschungUnknown
-
National Cancer Institute (NCI)Completed