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Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells and Anti-CTLA4

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Melanoma

Intervention: Cyclophosphamide (Drug); CD8+ T Cells (Procedure); Interleukin-2 (Drug); Ipilimumab (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Cassian Yee, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Cassian Yee, MD, Phone: 713-792-2921

Summary

The goal of this clinical research study is to learn about the safety of giving CD8+T cells with ipilimumab, cyclophosphamide, and IL-2 (aldesleukin). Researchers also want to learn if this combination can help to control metastatic melanoma. This study is divided into 2 parts: leukapheresis and treatment. In the leukapheresis part, blood cells will be collected from you to be made into modified CD8+T cells and given back to you in the treatment part. CD8+T cells are a type of white blood cell. Researchers grow the T cells in the laboratory, and they are designed to find melanoma cancer cells and may kill them. Ipilimumab and aldesleukin are designed to increase the immune system's ability to fight cancer. Cyclophosphamide will be used at a very low dose to weaken the body's natural defense against the T-cell transplant, so that the transplanted T-cells have a chance to grow and multiply.

Clinical Details

Official title: Phase II Study of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells and Anti-CTLA4 for Patients With Metastatic Melanoma

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Response

Detailed description: Study Drug Administration: If you agree to take part in this study, you will receive cyclophosphamide by vein over

about 30-60 minutes on Day - 2 (2 days before you receive the CD8+ T cells). If the doctor

thinks it is needed, you will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drug is given and its risks. On Day 0, you will receive the CD8+ T cells by vein over about 30-60 minutes. You will stay in the hospital overnight after the dose. Starting within 6 hours after the CD8+T cell infusion and then 2 times a day after that for 14 days, you will give aldesleukin as an injection into your skin around your abdomen. You will be taught how to give yourself these injections. On Days 1, 22, 43, and 64, you will receive ipilimumab by vein over about 90 minutes. Study Visits:

On Day - 2:

- You will have a physical exam.

- Blood (about 1 tablespoon) will be drawn for routine tests. This routine blood draw

will include a pregnancy test if you can become pregnant. To continue your participation in this study, you cannot be pregnant. On Days 0, 7, 14, 22, 28, 35, 43, 49, 56, 64, 70, 77, 84, 112, and 140:

- You will have a physical exam.

- Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and

tests on how long the T-cells survive in your body.

- Between Day 35 and 42 and again between Day 77 and 84, you will have a CT scan to check

the status of the disease. On Day 3, blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and tests on how long the T-cells survive in your body. If the doctor thinks it is needed to confirm the status of the disease, blood (about 1½ tablespoons) will be drawn every 3-6 months for up to 3 years. The study tests may be repeated or you may have additional tests performed anytime the doctor thinks it is needed. Some of the study tests may be done at your local clinic if you cannot return to MD Anderson. The study staff will discuss this with you. Length of Treatment: The treatment portion of the study will last until Day 64. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after the follow-up. End-of-Study Visit: At Day 168:

- You will have a physical exam.

- Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and

tests on how long the T-cells survive in your body. Follow-Up: Every 3 months after Day 84, unless the disease gets worse or you start another cancer therapy, you will have a CT scan or x-rays to check the status of the disease. Every 3 months for up to 5 years, the study staff will call you or ask your doctor how you are doing. If you are called, the calls should last about 10-15 minutes. If the doctor thinks it is needed, you will return to the clinic every 4-6 weeks or as often as the doctor thinks is needed. Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and tests on how long the T-cells survive in your body. This is an investigational study. CD8+T cells are not FDA approved or commercially available. They are currently being used for research purposes only. Cyclophosphamide, ipilimumab, and aldesleukin are FDA approved and commercially available for the way they are being used in this study. Up to 30 participants will be enrolled in this multicenter study. Up to 20 will take part at MD Anderson.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Histopathologic documentation of melanoma concurrent with the diagnosis of metastatic disease. 2. Male or female subjects >/= 18 years of age. 3. Expression of HLA-A2. 4. ECOG/ Zubrod performance status of '0-1'. 5. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion, and at least 8 weeks after the study drug is stopped. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. 6. Men must be willing and able to use an acceptable method of birth control, for at least 3 months after completion of the study, if their sexual partners are WOCBP. 7. Willing and able to give informed consent.

8. Adequate venous access - consider PICC or central line.

9. Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, CT scan). 10. At least 4 Weeks must have elapsed since the last chemotherapy, radiotherapy or major surgery. At least 6 Weeks for nitrosoureas, mitomycin C and liposomal doxorubicin. If started before T-cell administration, ipilimumab infusions must be least 21 days apart. 11. Toxicity related to prior therapy must either have returned to /= 3. 0 x ULN •AST/ALT >/= 2. 5 x ULN, •Bilirubin >/= 3 x ULN 10. Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy. 11. Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose. 12. Patients may not be on any other treatments for their cancer aside from those included in the protocol. Patients may not undergo another form of treatment concurrently with this study. 13. Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception. Women of childbearing potential with a positive pregnancy test within 3 days prior to entry.

Locations and Contacts

Cassian Yee, MD, Phone: 713-792-2921

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: January 2015
Last updated: June 23, 2015

Page last updated: August 23, 2015

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