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Sponsors and Collaborators: |
University of Virginia National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118274 |
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with cyclophosphamide after surgery may cause a stronger immune response to kill any remaining tumor cells. It may also prevent or delay the recurrence of melanoma.
PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: cyclophosphamide Drug: incomplete Freund's adjuvant Drug: melanoma helper peptide vaccine Drug: multi-epitope melanoma peptide vaccine Drug: tetanus toxoid helper peptide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Multicenter Trial to Evaluate the Effects of Administration of Cyclophosphamide and Melanoma-Derived Helper Peptides on the Immunogenicity of a Class I MHC-Restricted Peptide-Based Vaccine in Participants With Resected Melanoma |
Estimated Enrollment: | 173 |
Study Start Date: | March 2005 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
Patients receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
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Drug: incomplete Freund's adjuvant
Given intradermally and subcutaneously
Drug: multi-epitope melanoma peptide vaccine
Given intradermally and subcutaneously
Drug: tetanus toxoid helper peptide
Given intradermally and subcutaneously
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Arm II: Experimental
Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
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Drug: cyclophosphamide
Given IV
Drug: incomplete Freund's adjuvant
Given intradermally and subcutaneously
Drug: multi-epitope melanoma peptide vaccine
Given intradermally and subcutaneously
Drug: tetanus toxoid helper peptide
Given intradermally and subcutaneously
|
Arm III: Experimental
Patients receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
|
Drug: incomplete Freund's adjuvant
Given intradermally and subcutaneously
Drug: melanoma helper peptide vaccine
Given intradermally and subcutaneously
Drug: multi-epitope melanoma peptide vaccine
Given intradermally and subcutaneously
|
Arm IV: Experimental
Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
|
Drug: cyclophosphamide
Given IV
Drug: incomplete Freund's adjuvant
Given intradermally and subcutaneously
Drug: melanoma helper peptide vaccine
Given intradermally and subcutaneously
Drug: multi-epitope melanoma peptide vaccine
Given intradermally and subcutaneously
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to HLA-type (HLA-A1 positive vs HLA-A2 positive, HLA-A1 negative, or -A3 negative vs HLA-A3 positive, or -A1 negative) and participating center (University of Virginia [UVA] vs non-UVA). Patients are randomized to 1 of 4 treatment arms.
Treatment in all arms continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 173 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed melanoma
Has undergone surgical resection or stereotactic radiosurgery for malignant melanoma ≥ 1 week but ≤ 6 months ago
Brain metastases allowed provided all of the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
The following immunologic conditions are allowed:
Other
No uncontrolled diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior vaccination with any of the synthetic peptides used in this study
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Pennsylvania | |
Fox Chase Cancer Center - Philadelphia | |
Philadelphia, Pennsylvania, United States, 19111-2497 | |
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 | |
United States, Virginia | |
University of Virginia Cancer Center | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | Craig L. Slingluff, MD | University of Virginia |
Responsible Party: | University of Virginia Cancer Center ( Craig L. Slingluff, Jr ) |
Study ID Numbers: | CDR0000430929, UVACC-HIC-11491, UVACC-34104, UVACC-MEL-44, UVACC-GCRC-CLS013, UVACC-HITC-02620, MDA-2005-0070 |
Study First Received: | July 8, 2005 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00118274 |
Health Authority: | United States: Federal Government |
stage II melanoma stage III melanoma stage IV melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Freund's Adjuvant |
Cyclophosphamide Nevus Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Nevi and Melanomas Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |