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

All Drugs and Chemicals

Vaccines

Monatide (IMS 3015)

Adjuvants, Immunologic

Immunologic Factors

Peptide vaccine with Montanide ISA 51 GM-CSF

Montanide ISA 51

Jeffrey Weber

This is a study of a melanoma vaccine. Study participants will have melanoma that invaded deeply and spread to lymph nodes or another location. Although the participants' melanoma has been removed, there is a greater than 1 out of 2 chance it will return. There will be approximately 40 subjects in this study. The patients will have already taken part in a melanoma vaccine study, and in this current study, they will continue to receive booster injections of a similar vaccine given for two additional years.

This study will test an experimental vaccine. The vaccine contains peptides which are fragments of substances made by most melanomas. The substances are tyrosinase, gpl00 and melanoma antigen recognized by T cells (MART-1). The vaccine also includes an assistant called Montanide ISA 51. The assistant stimulates the immune system. This study will also test the effects of a second assistant granulocyte-macrophage colony-stimulating factor (GM-CSF). All participants will receive the vaccine and assistant Montanide ISA 51, but only half will receive the assistant GM-CSF. The patients have a one in two chance of receiving the assistant called GM-CSF. The main purpose of this study is to find out if the booster injections increase the body's immunity to melanoma and prevent its level of immunity from getting lower over time. The investigators also wish to know if the GM-CSF increases the body's immunity to melanoma when given with the melanoma vaccine.

The vaccine and assistant Montanide ISA 51 are not approved by the Food and Drug Administration (FDA). The assistant GM-CSF is approved by the FDA to increase infection-fighting white blood cells after chemotherapy. It is not approved by the FDA for treatment of melanoma. However, the FDA is permitting the vaccine and the assistants to be tested in this study.

Continuation Booster Trial After a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With or Without GM-CSF for Patients With Melanoma

A Randomized Phase II Continuation Booster Trial After a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With or Without GM-CSF for Patients With Resected Stages IIB/C, III, and IV Melanoma

University of Southern California

Symptoms and General Pathology

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Disease Attributes

Antineoplastic Agents

Molgramostim

Sargramostim

Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Arm A is patients with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy.

Arm B is an exploratory arm of 10 patients who have failed prior anti-PD1 therapy.

500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months

SurVaxM

100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months

1 ml per dose dosed every two weeks for 4 doses and then every 3 months

David Peereboom, MD

The main purpose of this study is to assess the clinical activity of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma.

Primary objective: Assess clinical activity of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma using progression free survival at 6 months (PFS-6).

Secondary objective: : Assess safety and tolerability of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma.

This is a Phase II study of two arms in participants with recurrent glioblastoma. Arm A will include participants with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy. Arm B is an exploratory arm of 10 participants who have failed prior anti-PD1 therapy.

All patients will receive the study drug combination consisting of SurVaxM and pembrolizumab (PEM) with no randomization, stratification or dose escalation.

Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence

Phase II Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence

Will share main findings of the clinical study report (CSR)

Assess clinical activity of Pembrolizumab and SurVaxM in patients with recurrent glioblastoma using PFS at 6 months (PFS-6)

Safety and tolerability of Pembrolizumab and SurVaxM in patients with recurrent glioblastoma measured on ongoing basis with CTCAE v 5 grading as per NCI. Grade 1-2 and 3-5 events will be recorded and reported.

David Peereboom

Principal Investigator

Analgesics

Anti-Infective Agents

Interleukin-2

polysaccharide-K

Analgesics, Non-Narcotic

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antiviral Agents

Interferons

Protective Agents

Radiation-Protective Agents

melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).

High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)

27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).

High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)

melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).

High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)

27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).

High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)

Glycoprotein 100 (GP100): 209-217 (210M)

720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours and continuing for up to 4 days (a maximum of 12 doses).

Interleukin-2 (IL-2)

Melanoma antigen recognized by T-cells (MART)-1: 27-35

27-35 (27L): melanoma antigen recognized by T-cells (MART)-1

melanoma antigen recognized by T-cells (MART)-1: 26-35(27L)

Steven A Rosenberg, M.D.

This study will examine the effectiveness and side effects of an experimental vaccine to prevent recurrence of melanoma. The likelihood of melanoma returning is higher in patients who have melanoma lesions deep in the skin, in patients who have had positive lymph nodes, and in patients who have had surgery for metastatic disease (cancer that has spread beyond the primary site). Melanoma tumors produce proteins called glycoprotein 100 (gp100) and melanoma-associated antigen recognized by T cells 1 (MART-1). Vaccination with specific pieces of these proteins (peptides) may boost the immune system's fight against the cancer. The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the immune response to the peptide.

Patients 16 years of age and older whose melanoma has been surgically removed and who are currently free of disease may be eligible for this study. Candidates will be screened with a physical examination and blood and urine tests. An electrocardiogram (EKG), x-rays and other imaging studies will be done if recent results are not available. Some candidates may require heart tests, such as a cardiac stress test or echocardiogram, or lung function tests. In addition, all candidates will be tested for human leukocyte antigen (HLA) tissue type; patients must be type human leukocyte antigens (HLA-A)\*0201, the type on which this vaccine is based.

Participants will be randomly assigned to receive one of four different vaccines to determine which peptides offer the best immunity. Each treatment course consists of two injections of the vaccines every 3 weeks for four times. The injections are given under the skin of the thigh. After every other treatment course (every 6 months), patients will undergo a series of x-rays and scans to look for tumor. The immunizations may continue for up to 12 months as long as the melanoma does not return. The injections are given at the National Institutes of Health (NIH) Clinical Center. Patients are monitored for 1 hour after each injection and have blood tests and a physical examination to look for treatment side effects.

Patients will be followed with blood tests every 12 weeks to monitor body functions. They will also undergo leukapheresis-a procedure to collect white blood cells-before starting treatment and about 3 to 4 weeks after the fourth vaccine to evaluate how the vaccines affect the action of the immune system cells. For this procedure, blood is drawn through a needle in the arm, similar to donating blood. The blood goes through a machine that separates out the lymphocytes (white blood cells), and the rest of the blood is returned through a needle in the other arm. Some patients may undergo a biopsy-surgical removal of a small piece of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the effects of the vaccines on the tumor immune cells.

Patients whose disease returns during the first course of vaccine therapy will have surgery to remove the tumor and will continue to receive the vaccine treatment. Patients whose tumor returns after completing one course of therapy may receive a substance called interleukin-2 (IL-2), which can boost immune function against the tumor. interleukin-2 (IL-2) is given intravenously (through a small tube placed in a vein) every 8 hours for 4 days. This regimen is repeated after 10 to 14 days. Those who respond to interleukin-2 (IL-2) will have a third course of treatment after 2 months. Patients whose disease recurs after treatment will be taken off the study and will be referred back to their referring physician or to another study, if an appropriate one is available.

Human leukocyte antigens (HLA-A)\*0201 positive patients at high risk for recurrence of melanoma, or completely resected metastatic melanoma will receive immunization with peptides representing human leukocyte antigen (HLA)-restricted T cell epitopes of the melanoma antigen recognized by T-cells (MART-1) or glycoprotein 100 (gp100) melanoma antigens emulsified in Montanide ISA-51 or Montanide trademark(TM) ISA 51 vegetable grade (VG). Patients will be randomized to receive one of three different melanoma antigen recognized by T-cells (MART-1) peptides or to receive a combination of a melanoma antigen recognized by T-cells (MART-1) peptide plus a glycoprotein 100 (gp100) peptide. This study is designed to evaluate the immunologic effects of the different peptide immunizations.

Peptide Vaccination for Patients at High Risk for Recurrent Melanoma

Randomized Comparison of Peptide Immunization in Patients at High Risk for Recurrence of Melanoma

Immunologic monitoring will be conducted using in vitro sensitization assays. The immunologic response in these assays will be considered positive if at least a two-fold increase in vaccine specific interferon gamma (y-IFN) secretion is seen between post vaccination specimens compared to the pre vaccination specimens.

Response is measured from the time measurement criteria are first met for complete response (CR) or partial response (PR) (whichever is first) until the first date that recurrent disease is objectively documented. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.

National Cancer Institute (NCI)

Dr. Steven Rosenberg

Adj-2 MART-1: 27-35

Adj-2 HD IL-2 After MART-1: 27-35

Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4

Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)

Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4

Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)

Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4

Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Steven A. Rosenberg, M.D.

The number of participants analyzed and results are correct. We do not have the immunologic response rate data for all patients.

Immunologic Response Rate

Number of Participants With Adverse Events

The number of participants analyzed and results are correct. We do not have the response rate data for all patients.

Response Rate

Overall Study

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Wilms Tumor

Lymphoma

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Wilms' Tumor

Lymphosarcoma

This is a Phase II study evaluating the safety and efficacy of the WT1 peptide vaccine in patients who are in CR from Acute Myeloid Leukemia (AML).

Six vaccinations of the WT1 peptide preparation (1.0 ml of emulsion) will be administered on weeks 0, 2, 4, 6, 8, and 10. All vaccinations will be administered subcutaneously with vaccination sites rotated among extremities. Patients who are clinically stable and have not had disease progression, may receive up to 6 more vaccinations administered appropriately every month.

WT1 peptide vaccine

Peter Maslak, MD

To determine whether the WT1 vaccine causes an immune response which is safe and able to keep the leukemia from coming back.

The purpose of this study is to determine whether the WT1 vaccine causes an immune response which is safe and able to keep the leukemia from coming back. While vaccines have been used in infectious diseases like smallpox and measles,the idea about using vaccines in a cancer like AML/ALL is really a new use of the idea of vaccines.The WT-1 vaccine is made up of protein pieces that the immune system can recognize as abnormal. The doctor thinks that the WT-1 protein is important in AML/ALL and using some lab tests they are still able to find some of it in the bone marrow. By attacking this small amount of the protein they hope to get rid of any small amount of AML that is still in the body.

WT-1 Analog Peptide Vaccine in Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)

Phase II Trial of a WT-1 Analog Peptide Vaccine in Patients in Complete Remission (CR) From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)

of the WT1 peptide vaccine administered to patients in CR from AML. Early toxicity will be assessed at weeks 2 and 4,. Routine toxicity assessments will continue throughout the trial. Any toxicity noted in the trial will be graded in accordance with Common Toxicity Criteria, version 4.0 (CTCAE 4.0) developed by the National Cancer Institute.

The primary efficacy measure is defined as overall survival at 3 years.

via CD4+ T cell proliferation, CD3+ T cell interferon- γ release (ELISPOT and / or flow cytometry) and WT1 peptide tetramer staining.

as measured by RT-PCR for WT1 transcript.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Continuation Booster Trial After a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With or Without GM-CSF for Patients With Melanoma	NCT00184067	Melanoma	Montanide ISA 5...	18 Years -	University of Southern California
Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence	NCT04013672	Recurrent Gliob...	Pembrolizumab SurVaxM Sargramostim Montanide ISA 5...	18 Years -	Case Comprehensive Cancer Center
Continuation Booster Trial After a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With or Without GM-CSF for Patients With Melanoma	NCT00184067	Melanoma	Montanide ISA 5...	18 Years -	University of Southern California
Peptide Vaccination for Patients at High Risk for Recurrent Melanoma	NCT00059475	Melanoma	Glycoprotein 10... Interleukin-2 (... Montanide ISA 5... Melanoma antige... 27-35 (27L): me... melanoma antige...	7 Years -	National Institutes of Health Clinical Center (CC)
WT-1 Analog Peptide Vaccine in Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)	NCT01266083	Acute Myeloid L... Acute Lymphobla...	WT1 peptide vac...	18 Years -	Sellas Life Sciences Group
Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence	NCT04013672	Recurrent Gliob...	Pembrolizumab SurVaxM Sargramostim Montanide ISA 5...	18 Years -	Case Comprehensive Cancer Center

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