Inclusion Criteria:
- pathologically confirmed advanced malignancy that is metastatic or unresectable and
which is refractory to standard therapy or for which thee is no standard therapy that
provides benefits for >/= 3 months
- measurable or non-measurable disease at baseline
- at least 4 weeks since the last dose of chemotherapy, radiation therapy,
immunotherapy, or surgery; at least 6 weeks for therapy which is known to have
delayed toxicity; at least 4 weeks since treatment with biologic/targeted therapies;
at least 2 weeks since last hormonal therapy
- will not be treated with any other chemotherapy, immunotherapy, radiotherapy or
investigational drug while enrolled on this protocol
- age >/= 18 year, male or female
- Eastern Cooperative Oncology Group performance status 0,1,or 2
- Serum potassium and magnesium levels within institutional normal limits. Total serum
calcium or ionized calcium level must be greater than or equal to the low limit of
normal.
- Adequate renal function, defined by serum creating = 1.5 x ULN
- Adequate hepatic function
- Adequate bone marrow function WOCBP, a negative serum pregnancy test result at
screening.
- WOCBP or men whose sexual partners are WOCBP who are willing to use an acceptable
method of contraception for at least 1 month prior to study entry, for the duration
of the study, and for at least 3 months after the last dose of study medication
- Signed and dated IRB approved ICF before any protocol specific screening procedures
are performed
Exclusion Criteria:
- serious uncontrolled medical disorder or active infection which would impair the
patient to receive protocol therapy.
- Uncontrolled or significant cardiovascular diseae
- dementia or altered mental status that would prohibit the understanding or rendering
of informed consent
- not recovered from the adverse effects of prior therapy at the time of enrollment =
grade 1
- symptomatic brain metastases which are either untreated or uncontrolled by surgery
and or radiotherapy
- received extensive prior radiation therapy to the bone marrow
- immunocompromised, including subjects know to be infected with HIV
- history of hypersensitivity to compounds of similar chemical or biologic composition
to the antibody women how are pregnant or breastfeeding
- WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an
acceptable method of contraception for at least 1 month prior to study entry, for the
duration of the study, and for at least 3 months after the last dose of study
medication