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Protocol Details

A Phase II Trial to Evaluate the Ability of a Dendritic Cell Vaccine to Immunize Melanoma or Epithelial Cancer Patients Against Defined Mutated Neoantigens Expressed by the Autologous Cancer

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-C-0177

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 70

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women and Fetuses;
Children

Special Instructions

Currently Not Provided

Keywords

Cell Therapy;
Immunotherapy;
Vaccines

Recruitment Keyword(s)

None

Condition(s)

Melanoma;
Gastrointestinal Cancer;
Breast Cancer;
Ovarian Cancer;
Pancreatic Cancer

Investigational Drug(s)

Peptide loaded dendritic cell vaccine

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: Peptide loaded dendritic cell vaccine

Supporting Site

National Cancer Institute

Background:

Exomes are the parts of DNA that make proteins. Researchers are finding a way to read the letters in the exome. Incorrect letters are called mutations. Tumors contain specific mutations. Researchers can find these mutations in tumors to make treatments. Researchers want to use pieces of participants tumors to find the tumor-specific mutations. They also will take participants white blood cells to make a vaccine that they hope will shrink the tumors.

Objectives:

To see if dendritic vaccine tumor-fighting cells are safe and can cause certain cancer tumors to shrink.

Eligibility:

Adults ages 18-70 who have metastatic melanoma or metastatic epithelial cancer

Design:

The first part of this study was done under protocol 03-C-0277. In that study, white blood cells and pieces of participants' tumors were taken to make a vaccine.

In this study, participants will get a vaccine every 2 weeks for 8 weeks. It will be given both in a vein and under the skin. At each visit, participants will have a physical exam and have blood taken. They will talk about any side effects they have.

After treatment ends, participants will have many follow-up visits for the first year, then once each year after that. Visits will last up to 2 days each. They will include lab tests, imaging studies, and a physical exam. Blood will be taken at each visit. At the first follow-up visit, participants may have leukapheresis, which they also had as part of protocol 03-C-0277. Participants may not have to return to the Clinical Center for these visits.

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Eligibility

INCLUSION CRITERIA:

- Metastatic melanoma or epithelial cancer with at least one lesion that is resectable or in selected cases, available PBMCs

-Measurable and evaluable metastatic disease per RECIST 1.1 criteria

-Confirmation of the diagnosis of metastatic cancer by the Laboratory of Pathology of NCI.

-All patients must be refractory to approved standard systemic therapy.

-Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.

-Greater than or equal to 18 years of age and less than or equal to 70 years of age.

-Clinical performance status of ECOG 0, 1, 2

-Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment.

-Serology:

--Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus are less responsive to the experimental treatment and more susceptible to its toxicities.)

--Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.

-Hematology

---Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim

---WBC greater than or equal to 3000/mm^3

---Platelet count greater than or equal to 100,000/mm^3

---Hemoglobin > 8.0 g/dl. Subjects may be transfused to reach this cut-off.

---CD4 count > 200/uL

-Chemistry:

--Serum ALT/AST less than 5.0 x ULN

--Serum Creatinine less than or equal to 1.6 mg/dl

--Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's Syndrome, who must have a total bilirubin less than or equal to 3.0 mg/dl.

-More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the vaccine, and patients toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).

Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.

-Ability of subject to understand and the willingness to sign a written informed consent document.

-Subjects must be co-enrolled On protocol 03-C-0277.

EXCLUSION CRITERIA:

-Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.

-Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).

-Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).

-Active systemic infections (requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses.

-Patients who are receiving any other investigational agents.


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Citations:

Klein L, Hinterberger M, Wirnsberger G, Kyewski B. Antigen presentation in the thymus for positive selection and central tolerance induction. Nat Rev Immunol. 2009 Dec;9(12):833-44. doi: 10.1038/nri2669.

Abramson J, Giraud M, Benoist C, Mathis D. Aire's partners in the molecular control of immunological tolerance. Cell. 2010 Jan 8;140(1):123-35. doi: 10.1016/j.cell.2009.12.030.

Bos R, Marquardt KL, Cheung J, Sherman LA. Functional differences between low- and high-affinity CD8(+) T cells in the tumor environment. Oncoimmunology. 2012 Nov 1;1(8):1239-1247.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Steven A. Rosenberg, M.D.
National Cancer Institute (NCI)



Margaret Shovlin, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 4N115
10 Center Drive
Bethesda, Maryland 20892
(866) 820-4505
IRC@nih.gov

Recruitment Center - SB
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Building 10, Room 2-1730, Bethesda, Maryland 20892, United States
(866) 820-4505
ncisbirc@mail.nih.gov

Clinical Trials Number:

NCT03300843

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