Clinical Trial Details
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NCT00967577 : 177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Histologically, or cytologically documented, advanced stage, malignant adult solid
tumors (except prostate cancer) that are refractory to, or recurrent from, standard
therapy or for which no curative standard therapy exists. This will include, but is
not limited to patients with cancers of the kidney, urothelium, head and neck,
breast, non-small cell lung, colorectal, pancreas, ovary, esophagus and gliomas.

- Metastatic or recurrent solid tumor malignancy defined by abnormal CT, MRI, PET scan,
CXR and/or bone scan

- Progressive disease manifest by: Development of new lesions or an increase in size of
preexisting lesions on imaging study or by physical examination.

- Subjects must have recovered from the acute toxicities of any prior therapy, and not
received chemotherapy, radiation therapy or other investigational anticancer
therapeutic drug for at least 4 weeks prior to J591 administration in this trial

- All subjects must have archived or current tissue (from a primary or metastatic
focus) available for PSMA determination.

- Subjects on bisphosphonate therapy or denosumab must be on a stable dose and must
have started therapy > 4 weeks prior to protocol therapy.

- Subjects will be informed as to the potential risk of procreation while participating
on this trial and will be advised to use effective contraception during the entire
study period. Females of child-bearing potential must have a negative pregnancy test.

Exclusion Criteria:

- Use of red blood cell or platelet transfusions within 4 weeks of treatment.

- Use of hematopoietic growth factors within 4 weeks of treatment.

- Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.

- Prior radiation therapy encompassing >25% of skeleton.

- Prior treatment with 89Strontium or 153Samarium containing compounds (e.g.
Metastron®, Quadramet®)

- Platelet count <150,000/mm3 or history of platelet count abnormality or dysfunction.

- Absolute neutrophil count (ANC) <2,000/mm3

- Hematocrit <30 percent or Hemoglobin < 10 g/dL

- Abnormal coagulation profile (PT or INR, PTT) > 1.3x upper limit of normal (ULN)

- Serum creatinine > 2x ULN

- AST (SGOT) >2.5x ULN

- Bilirubin (total) >1.5x ULN

- Active serious infection

- Active angina pectoris or NY Heart Association Class III-IV

- ECOG Performance Status > 2

- Deep vein thrombosis and/or pulmonary embolus within 1 month of enrollment.

- Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or
hematological organ systems which might preclude completion of this study or
interfere with determination of causality of any adverse effects experienced in this

- Prior investigational therapy (medications or devices) within 6 weeks of treatment.

- Known history of HIV.

- Known leukemia or myelodysplastic syndrome

- Prior allergic reaction to Gadolinium contrast.
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