Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well radiolabeled monoclonal antibody works in treating patients with progressive metastatic androgen-independent adenocarcinoma (cancer) of the prostate.
Full description
OBJECTIVES:
Primary
Determine the prostate-specific antigen (PSA) response rate in patients with progressive metastatic androgen-independent adenocarcinoma of the prostate treated with lutetium Lu 177 monoclonal antibody J591. Determine the measurable disease response rate in patients treated with this drug.
Secondary
Determine the toxicity of this drug in these patients. Determine the duration of biochemical PSA and/or measurable disease response in patients treated with this drug. Determine the incidence of human anti-J591 antibody (HAHA) response in patients treated with this drug. Correlate hematological toxicity of this drug with bone marrow involvement (bone scan index) in these patients. Determine the survival rate in patients treated with this drug. Determine the targeting of this drug to known tumor sites in these patients. Determine the tumor-absorbed radiation dose in patients treated with this drug.
OUTLINE: This is a multicenter, open-label study.
Patients receive a single dose of lutetium Lu 177 monoclonal antibody J591 IV on day 1. Patients then undergo radionuclide scanning between days 6-8 to confirm tumor targeting by the study drug.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 17-32 patients will be accrued for this study.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Progressive disease after prior antiandrogen therapy, as evidenced by at least 1 of the following parameters:
New osseous lesions on bone scan
Greater than 25% increase in the sum of the products of the longest perpendicular diameters of the lesions OR the appearance of new lesions on MRI or CT scan
Rising prostate-specific antigen (PSA) despite adequate medical or surgical castration therapy
Measurable or evaluable disease
Serum testosterone ≤ 50 ng/dL
No confluent lesions involving axial and appendicular skeleton on bone scan ("superscan")
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
See Disease Characteristics
Concurrent luteinizing hormone-releasing hormone (LHRH) analog allowed provided 1 of the following is true:
More than 4 weeks since prior corticosteroids
More than 4 weeks since prior adrenal hormone inhibitors
Concurrent low-dose prednisone (≤ 5mg/day) for adrenal insufficiency allowed
No concurrent finasteride
Radiotherapy
Surgery
Other
More than 4 weeks since prior PC-SPES
More than 4 weeks since prior investigational therapy (medications or devices)
At least 1 week since prior aspirin and/or nonsteroidal anti-inflammatory agents possessing antiplatelet activity
At least 1 week since prior antiplatelet medication, including the following:
No concurrent anticoagulant medications (for platelet count < 50,000/mm^3), including the following:
No other concurrent investigational therapy
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal