Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Vaccines

Monatide (IMS 3015)

Freund's Adjuvant

Immunologic Factors

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Adjuvants, Immunologic

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.

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.

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.

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.

incomplete Freund's adjuvant

melanoma helper peptide vaccine

multi-epitope melanoma peptide vaccine

tetanus toxoid helper peptide

cyclophosphamide

Craig L. Slingluff, MD

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.

OBJECTIVES:

Primary

* Determine the safety of adjuvant vaccine therapy comprising multi-epitope melanoma peptides (MP) and multi-epitope melanoma helper peptides (MHP) emulsified in Montanide ISA-51 in patients with resected stage IIB-IV melanoma.
* Determine the safety of administering cyclophosphamide before vaccination in these patients.
* Compare the magnitude of immune response against vaccination comprising MP in combination with either MHP or tetanus toxoid helper peptide (TET) emulsified in Montanide ISA-51 with vs without cyclophosphamide in these patients.

Secondary

* Compare the response rate and persistence of immune responses in patients treated with these regimens.
* Compare the magnitude of immune response against vaccination comprising TET or MHP with vs without cyclophosphamide in these patients.
* Compare the response rate and persistence of immune response against vaccination comprising TET or MHP with vs without cyclophosphamide in these patients.
* Determine the delayed-type hypersensitivity response to the peptide components of these vaccines in these patients.
* Compare, preliminarily, disease-free survival of patients treated with these regimens.

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.

* Arm I: Patients receive vaccine comprising multi-epitope melanoma peptides (MP) and tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally (ID) and subcutaneously (SC) on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
* Arm II: Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine as in arm I.
* Arm III: Patients receive vaccine comprising MP and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 ID and SC on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
* Arm IV: Patients receive cyclophosphamide as in arm II. Patients then receive vaccine as in arm III.

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.

Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma

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

Number of participants with dose-limiting toxicities

The primary end point was the maximum cumulative circulating CD8+ T cell response to 12 melanoma peptides (12MP) measured by ELISpot assay over the first six vaccines (to day 50).

National Cancer Institute (NCI)

Craig L Slingluff, Jr

Professor of Surgery

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.

incomplete Freund's adjuvant: Given intradermally and subcutaneously

multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously

tetanus toxoid helper peptide: Given intradermally and subcutaneously

Arm I

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.

incomplete Freund's adjuvant: Given intradermally and subcutaneously

multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously

tetanus toxoid helper peptide: Given intradermally and subcutaneously

cyclophosphamide: Given IV

Arm II

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.

incomplete Freund's adjuvant: Given intradermally and subcutaneously

melanoma helper peptide vaccine: Given intradermally and subcutaneously

multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously

Arm III

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.

incomplete Freund's adjuvant: Given intradermally and subcutaneously

melanoma helper peptide vaccine: Given intradermally and subcutaneously

multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously

cyclophosphamide: Given IV

Arm IV

Total

Age, Categorical

Sex: Female, Male

Dr. Craig Slingluff

Intent to treat population including 167 eligible and 3 ineligible.

Safety of the Peptide Vaccines

Immunogenicity (CD8+ T Cell Response to 12 Melanoma Peptides, 12MP) as Measured by Elispot Assay, up to Day 50

Overall Study

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Laryngeal Diseases

Laryngeal Cancer

Hypopharyngeal Cancer

Tongue Cancer

Metastatic Squamous Neck Cancer With Occult Primary

mutant p53 peptide pulsed dendritic cell vaccine

adjuvant therapy

Robert L. Ferris, MD, PhD

RATIONALE: Vaccines made from a person's dendritic cells mixed with peptides may help the body build an effective immune response to kill tumor cells.

PURPOSE: This randomized phase I trial is studying the side effects of vaccine therapy in treating patients with head and neck cancer.

OBJECTIVES:

Primary

* Determine the toxicity of intranodally injected autologous dendritic cells (DC) loaded with wild-type p53 peptides with or without T-helper peptide epitope in patients with squamous cell carcinoma of the head and neck.

Secondary

* Determine the local and systemic immunomodulatory effects of this vaccine in these patients.

OUTLINE: This is a randomized, pilot study.

Patients undergo leukapheresis. The resulting dendritic cells (DC) are pulsed with wild-type (wt) p53 peptides with or without T-helper (Th) peptides. Individual autologous vaccines are prepared for each patient. Patients who are HLA-A2-DR4-negative are randomized to 1 of 2 treatment arms (arm I or arm II). Patients who are HLA-A2-DR4-positive are assigned to arm III.

* Arm I: Patients receive autologous DC loaded with HLA-A2.1-restricted wt p53 peptides only.
* Arm II: Patients receive autologous DC loaded with HLA-A2.1-restricted wt p53 peptides and Th tetanus toxoid peptide.
* Arm III (HLA-A2-DR4-positive patients only): Patients receive autologous DC loaded with HLA-A2.1-restricted wt p53 peptides and Th wt p53 peptide.

In all arms, each vaccine is administered by ultrasonography-guided inguinal intranodal injection over 30 minutes on days 0, 14, and 28.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Vaccine Therapy in Treating Patients With Head and Neck Cancer

Adjuvant p53 Peptide Loaded DC-Based Therapy for Subjects With Squamous Cell Cancer of the Head and Neck (A Phase I Safety and Immunogenicity Trial)

Robert Ferris

UPMC Endowed Professor and Chief, Division of Head and Neck Surgery, Department of Otolaryngology

Anti-Infective Agents

Molgramostim

Sargramostim

Imiquimod

Dimethyl Sulfoxide

Immunomodulating Agents

Interferons

Protective Agents

Antioxidants

sargramostim

dimethyl sulfoxide

imiquimod

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with imiquimod after surgery may help the body kill any remaining tumor cells.

PURPOSE: This randomized phase I trial is studying the side effects and best way to give vaccine therapy with or without imiquimod in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

OBJECTIVES:

* Determine the safety of adjuvant transdermal vaccine therapy comprising multi-epitope melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) in combination with Montanide ISA-51 or dimethyl sulfoxide with or without imiquimod in patients who have undergone surgical resection for stage II-IV melanoma.
* Determine, preliminarily, the immunogenicity of these regimens in these patients.
* Correlate, preliminarily, transdermal administration of these vaccines with the recruitment and maturation of epidermal Langerhans cells in these patients.
* Determine, preliminarily, the effects of timing of subsequent vaccine therapy comprising MP, TET, and GM-CSF emulsified in Montanide ISA-51, administered intradermally and subcutaneously, on the persistence of immune response in these patients.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive vaccine therapy comprising multi-epitope melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) emulsified in Montanide ISA-51 transdermally (TD) on days 1, 8, and 15. Patients then receive the vaccine intradermally (ID) and subcutaneously (SC) on days 29, 50, 71, 92, 113, and 134.
* Arm II: Patients receive vaccine therapy as in arm I. Patients also receive imiquimod topically on days 0, 7, and 14.
* Arm III: Patients receive vaccine therapy comprising MP, TET, GM-CSF, and dimethyl sulfoxide TD on days 1, 8, and 15. Patients then receive vaccine therapy comprising MP, TET, and GM-CSF emulsified in Montanide ISA-51 ID and SC on days 29, 50, 71, 92, 113, and 134.
* Arm IV: Patients receive vaccine therapy as in arm III and imiquimod as in arm II.

In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 3 and 5 weeks and then at disease progression.

PROJECTED ACCRUAL: A maximum of 26 patients (approximately 6 per treatment arm) will be accrued for this study within approximately 2 years.

Vaccine Therapy With or Without Imiquimod in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma

Evaluation of Different Adjuvants for the Transdermal Administration of a Peptide-Based Vaccine in Participants With High-Risk Melanoma

Professor, Department of Surgery

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

ovarian cancer peptide vaccine

Amir A. Jazaeri, MD

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with ovarian epithelial or primary peritoneal cancer.

OBJECTIVES:

* Determine the safety and immunogenicity of adjuvant vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, and sargramostim (GM-CSF) emulsified in Montanide ISA-51 in patients with previously treated ovarian epithelial or primary peritoneal cancer.

OUTLINE: This is an open-label study.

Patients receive vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, sargramostim (GM-CSF), and Montanide ISA-51 subcutaneously and intradermally to 2 different sites on days 1, 8, and 15. On day 22, patients undergo removal of the lymph node draining the vaccination site to determine whether the immune system is responding to the vaccine. Patients then receive additional vaccine as above only to the primary vaccination site on days 29, 36, and 43.

After completion of study treatment, patients are followed at 1 week, 1 month, every 3 months for 9 months, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 9 patients will be accrued for this study.

Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer

Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer

Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma	NCT00118274	Melanoma (Skin)	incomplete Freu... melanoma helper... multi-epitope m... tetanus toxoid ... cyclophosphamid...	18 Years - 120 Years	University of Virginia
Vaccine Therapy in Treating Patients With Head and Neck Cancer	NCT00404339	Head and Neck C...	mutant p53 pept... tetanus toxoid ... adjuvant therap...	18 Years - 120 Years	University of Pittsburgh
Vaccine Therapy With or Without Imiquimod in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma	NCT00118313	Melanoma (Skin)	incomplete Freu... multi-epitope m... sargramostim tetanus toxoid ... dimethyl sulfox... imiquimod adjuvant therap...	12 Years - 120 Years	University of Virginia
Vaccine Therapy in Treating Patients With Head and Neck Cancer	NCT00404339	Head and Neck C...	mutant p53 pept... tetanus toxoid ... adjuvant therap...	18 Years - 120 Years	University of Pittsburgh
Vaccine Therapy With or Without Imiquimod in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma	NCT00118313	Melanoma (Skin)	incomplete Freu... multi-epitope m... sargramostim tetanus toxoid ... dimethyl sulfox... imiquimod adjuvant therap...	12 Years - 120 Years	University of Virginia
Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer	NCT00091273	Ovarian Cancer Primary Periton...	incomplete Freu... ovarian cancer ... sargramostim tetanus toxoid ... adjuvant therap...	18 Years -	University of Virginia
Vaccine Therapy in Treating Patients With Head and Neck Cancer	NCT00404339	Head and Neck C...	mutant p53 pept... tetanus toxoid ... adjuvant therap...	18 Years - 120 Years	University of Pittsburgh

Spots Global Cancer Trial Database for tetanus toxoid helper peptide