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