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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Michael Morris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

MSKCC-03144

NCT ID:

NCT00081172

Start Date:

January 2004

Completion Date:

May 2006

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Adenocarcinoma
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021