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A Pilot Trial of the Combination of Vemurafenib with Adoptive Cell Therapy in Patients with Metastatic Melanoma
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
12-C-0114 |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Immunotherapy; |
Recruitment Keyword(s) |
None |
Condition(s) |
Metastatic Cancer; |
Investigational Drug(s) |
Young TIL |
Investigational Device(s) |
None |
Intervention(s) |
Drug: Vemurafenib |
Supporting Site |
|
- One possible treatment for advanced melanoma involves collecting white blood cells from the person with cancer and growing them in a laboratory. The cells can then be given back to the donor. This study will use this white blood cell treatment with the cancer treatment drug vemurafenib. Vemurafenib targets melanoma cells that have a mutation in the B-raf gene, and may be able to make them shrink.
Objectives:
- To see if vemurafenib and white blood cell therapy is a safe and effective treatment for advanced melanoma.
Eligibility:
- Individuals at least 18 years of age who have advanced melanoma that contains the B-raf genetic mutation.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- White blood cells will be collected from tumor cells. These cells will be collected during surgery or a tumor biopsy.
- Participants will have leukapheresis to collect additional white blood cells for the procedure.
- Participants will take vemurafenib twice a day, starting 3 weeks before receiving the white blood cells.
- Participants will have 1 week of chemotherapy to prepare their immune system to accept the white blood cells.
- Participants will receive an infusion of their collected white blood cells. They will also receive aldesleukin for up to 5 days to boost the immune system's response to the white blood cells. They will remain in the hospital until they have recovered from the treatment.
- Participants will have frequent follow-up visits to monitor the outcome of the treatment.
Eligibility
INCLUSION CRITERIA:
a. Measurable metastatic melanoma that expresses the VtoE BRAF mutation assessed in a CLIA certified laboratory.
b. Patients with 3 or less brain metastases are eligible. Note: If lesions are symptomatic or greater than or equal to 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible.
c. Greater than or equal to 18 years of age.
d. Willing to practice birth control during treatment and for four months after receiving all protocol related therapy.
e. Life expectancy of greater than three months
f. Willing to sign a durable power of attorney.
g. Able to understand and sign the Informed Consent Document
h. Clinical performance status of ECOG 0 or 1.
i. Hematology:
- Absolute neutrophil count greater than 1000/mm(3)
- Hemoglobin greater than 8.0 g/dl
- Platelet count greater than 100,000/mm(3)
j. 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 be less responsive to the experimental treatment and more susceptible to its toxicities.)
- Seronegative for hepatitis B antigen, or hepatitis C antibody or antigen.
k. Chemistry:
- Serum ALT/AST less than three times the upper limit of normal.
- Calculated creatinine clearance (eGFR) > 50 ml/min.
- Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 mg/dl.
l. More than four weeks must have elapsed since any prior systemic therapy at the time of treatment, and patients' toxicities must have recovered to a grade 1 or less (except for alopecia or vitiligo). Patients must have stable or progressing disease after prior treatment.
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 or as specified in the eligibility criteria in Section 2.1.1.
m. Six weeks must have elapsed since any prior anti-CTLA4 antibody therapy to allow antibody levels to decline.
n. Patients who have previously received any anti-CTLA4 antibody and have documented GI toxicity must have a normal colonoscopy with normal colonic biopsies.
o. EKG with mean QTc interval < 450 msec.
EXCLUSION CRITERIA:
a. Prior cell transfer therapy which included a myeloablative chemotherapy regimen (i.e. 1200 TBI or 200 TBI plus chemotherapy).
b. Previous treatment with Vemurafenib.
c. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
d. Systemic steroid therapy requirement.
e. Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
f. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
g. 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.)
h. History of severe immediate hypersensitivity reaction to any of the agents used in this study.
i. History of coronary revascularization or ischemic symptoms.
j. Any patient known to have an LVEF less than or equal to 45 percent.
k. In patients > 60 years old, documented LVEF of less than or equal to 45 percent.
l. Documented FEV1 less than or equal to 60 percent predicted tested in patients with:
- A prolonged history of cigarette smoking
- Symptoms of respiratory dysfunction
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: | |
| Steven A. Rosenberg, M.D. National Cancer Institute (NCI) National Institutes of Health BG 10-CRC RM 3-3940 10 CENTER DR BETHESDA MD 20814 (301) 496-4164 sar@mail.nih.gov |
June Kryk, R.N. National Cancer Institute (NCI) National Institutes of Health Building 10 Room 2-1730 10 Center Drive Bethesda, Maryland 20892 (301) 451-1929 ncisbirc@mail.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:
NCT01585415
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