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Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate

A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00081172
Enrollment
Unknown
Registered
2004-04-08
Start date
2004-01-31
Completion date
2006-05-31
Last updated
2013-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

Brief summary

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.

Detailed 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.

Interventions

RADIATIONlutetium Lu 177 monoclonal antibody J591

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Metastatic disease * 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 * Consecutive increase in PSA, determined by two separate measurements taken at least 1 week apart and confirmed by a third, and if necessary, a fourth measurement * PSA must be ≥ 5 ng/mL and ≥ 25% above the previous nadir * Measurable or evaluable disease * Serum testosterone ≤ 50 ng/dL * No confluent lesions involving axial and appendicular skeleton on bone scan (superscan) PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 70-100% Life expectancy * At least 6 months Hematopoietic * Absolute neutrophil count ≥ 2,000/mm\^3 * Hematocrit ≥ 30% * Hemoglobin ≥ 10 g/dL * Platelet count ≥ 150,000/mm\^3 * No serious hematologic illness that would preclude study participation Hepatic * AST ≤ 2 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * PTT normal * PT normal OR * INR normal * No serious hepatic illness that would preclude study participation Renal * Creatinine ≤ 2.5 mg/dL * Calcium ≤ 11 mg/dL * No serious renal illness that would preclude study participation Cardiovascular * No New York Heart Association class III or IV heart disease * No active angina pectoris * No prior deep vein thrombophlebitis within the past 3 months * No other serious cardiac illness that would preclude study participation Pulmonary * No pulmonary embolus within the past 3 months * No other serious respiratory illness that would preclude study participation Other * Fertile patients must use effective contraception * HIV negative * No serious CNS illness that would preclude study participation * No active serious infection not controlled by antibiotics * No other serious illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * More than 2 weeks since prior red blood cell or platelet transfusions * More than 2 weeks since prior hematopoietic growth factors * No prior monoclonal antibody therapy except ProstaScint® * No other concurrent monoclonal antibody-based therapy * No concurrent medication to support platelet count (e.g., oprelvekin) Chemotherapy * More than 4 weeks since prior cytotoxic chemotherapy Endocrine therapy * See Disease Characteristics * Concurrent luteinizing hormone-releasing hormone (LHRH) analog allowed provided 1 of the following is true: * Treatment is maintained during study participation * Treatment is terminated at least 10 weeks (for 1-month depot preparations), 24 weeks (for 3-month depot preparations), or 32 weeks (for 4-month depot preparations) prior to study entry * 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 * More than 4 weeks since prior radiotherapy * No prior radiotherapy to \> 25% of skeleton * No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium-containing compounds (e.g., Metastron® or Quadramet®) Surgery * Not specified 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: * Abciximab * Cilostazol * Clopidogrel * Dipyridamole * Ticlopidine * No concurrent anticoagulant medications (for platelet count \< 50,000/mm\^3), including the following: * Dalteparin * Danaparoid * Enoxaparin * Heparin * Warfarin * No other concurrent investigational therapy

Design outcomes

Primary

MeasureTime frame
Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026