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Study Summary
No. 2004-0069:.......Melanoma......Patrick Hwu......Melanoma Medical Oncology
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Study Summary Title
Study Summary
Number:
2004-0069
Study Title:Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma
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Physician New Patient Referral
Name:Patrick HwuPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Melanoma Medical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2921
Contact us about clinical trials
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General Information
Disease Group:MelanomaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Participants must return every 3 - 4 weeks for the first 2 months after
treatment. Then, every 1-3 months for the next 10 months.
Treatment
Agents:
Cyclophosphamide
Filgrastim
Fludarabine
Interleukin-2
Mesna
Ondansetron Hydrochloride
Pegfilgrastim
Home Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Participants will be in the hospital for approximately 7 days each course for 2
courses of high dose IL-2 given at 3 to 4 week intervals.
Description/
Intervention:
The goal of this clinical research study is to learn if a vaccine prepared from
special blood cells (dendritic cells) will improve the function of fighting
immune cells (T cells) specific for melanoma. These special blood cells and
immune cells will be taken from patient's blood and tissue and grown in the
laboratory and then given back to the patient. Researchers will also study the
ability of these cells to shrink or slow the growth of the metastatic melanoma
when given with chemotherapy and Interleukin-2 (IL-2). Researchers will also
study if this combination will help to control the disease if there is a BRAF
mutation of the melanoma.
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Study Objectives / Outcomes
The primary objective will be to determine whether patients receiving adoptively transferred, tumor antigen-specific T cells in combination with dendritic cells and high dose IL-2 have sustained persistence of infused T cells compared to patients treated with T cells and high dose IL-2 alone.

Secondary endpoints will include evaluations for tumor response and studies to determine whether dendritic cells enhance the infused T cells' anti-tumor activity and their ability to migrate to the tumor site. In addition, we will evaluate the characteristics of the infused T cells that correspond with effectiveness in vivo.

In a separate cohort (Cohort C) the primary endpoint will be the overall response rate of TIL treatment for patients who have not achieved PR or CR or have progressive disease from treatment of the BRAF inhibitor alone.
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Study Status Information
Study Activation / Registration Date:02/01/2006
IRB Review and Approval Date:08/04/2004
Study Type:Therapeutic
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients must have metastatic melanoma or stage III in-transit or regional nodal disease. (Turnstile I)

2) Patients must receive an MRI/CT of the brain or PET/CT within 6 months of consenting. If new lesions are present, PI or his designee should make final determination regarding enrollment. (Turnstile I)

3) Age greater than or equal to 12 years. (Turnstile I)

4) Clinical performance status of ECOG 0-2. (Turnstile I)

5) Patients previously treated with immunotherapy, targeted therapy, or no therapy will be eligible. Patients receiving cytotoxic agents will be evaluated by the PI or his designee as to suitable eligibility. (Turnstile I)

6) Patients must be HLA-A2 for cohort A. (Turnstile II-Chemotherapy/Cell Infusion-Inclusion Criteria)

7) Patients must have adequate TIL available. (Turnstile II)

8) Patients must have measurable metastatic melanoma. (Turnstile II - Chemotherapy/Cell Infusion -Inclusion Criteria).

9) Patients may have brain lesions which measure </= 1cm each. Lesions that are >1 cm that have been treated with SRS and in the opinion of the PI or his designee no longer represents active disease will also be allowed. (Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria).

10) Patients of both genders must practice birth control for four months after receiving the preparative regimen. (Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria).

11) Patients must have a documented negative pregnancy test (urine or serum) for women who have menstruation in the past 12 months and without sterilization surgery.

12) Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a barrier method of contraception throughout the study such as: condom, diaphragm, hormonal, IUD, or sponge plus spermicide. Abstinence is an acceptable form of birth control. (Turnstile II)

13) Pregnancy testing will be performed within 7 days prior to treatment.

14) Clinical performance status of ECOG 0 - 2 at the time of chemotherapy infusion. (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria).

15) Absolute neutrophil count greater than or equal to 750/mm3. (Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria).

16) Platelet count greater than or equal to 75,000/mm3. (Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria).

17) Hemoglobin greater than or equal to 8.0 g/dl. (Turnstile II - Chemotherapy/Cell Infusion).

18) Serum ALT less than three times the upper limit of normal. (Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria).

19) Serum creatinine less than or equal to 1.6 mg/dl. (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria).

20) 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 3.0 mg/dl. (Turnstile II - Chemotherapy/Cell Infusion - Inclusion Criteria).

21) Patients in Cohort A will be randomized to receive either TIL alone or TIL plus Dendritic cells.

22) A stress cardiac test (stress thallium, stress MUGA, dobutamine echocardiagram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion. (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria).

23) Pulmonary function tests (FEV1>65% or FVC>65%of predicted) within 6 months of lymphodepletion. (Turnstile II - Chemotherapy/Cell Infusion - Inclusion Criteria).

24) MRI/CT of the brain within 42 days of lymphodepletion. CT scan of chest/abdoment/pelvis or PET/CT within 30 days of lymphodepletion. Exception: Patients randomized to receive dendritic cells may have an MRI of the brain within 30 days of lymphodepletion. (Turnstile II-Chemotherapy/Cell Infusion-Inclusion Criteria)

25) Patients must be receiving Vemurafenib and failed to achieve PR or CR or have progressive disease in response to Vemurafenib treatment (Cohort C).

Exclusion Criteria:1) Has had prior systemic cancer cytotoxic chemotherapy within the past four weeks at the time of the start of the lymphodepletion regimen.

2) Has had prior B-RAF or MEK targeted therapy within 7 days prior to the start of the lymphodepletion regimen (Cohort A and Cohort B).

3) Is not receiving Vemurafenib treatment (Cohort C) (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)

4) Achieves PR or CR in response to Vemurafenib treatment (Cohort C).

5) Women who are pregnant or nursing will be excluded because of the potentially dangerous effects of the preparative chemotherapy on the fetus. (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)

6) Any active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, such as abnormal stress test and/or abnormal PFT. PI or his designee shall make the final determination regarding appropriateness of enrollment.(Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)

7) Any form of primary or secondary immunodeficiency. Must have recovered immune competence after chemotherapy or radiation therapy as evidenced by lymphocyte counts (> 500/mm3), WBC (> 3,000/mm3) or absence of opportunistic infections. (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)

8) Require steroid therapy or steroid-containing compounds, or have used systemic steroids in the past 30 days, or have used topical or inhalational steroids in the past 2 weeks prior to lymphodepletion. (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)

9) Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated. (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)

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Links
Registration Number: NCT00338377
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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