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Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer


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

Thank you

Trial Information

Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer


OBJECTIVES:

- Determine the antitumor effects of monoclonal antibody huJ591 in patients with
progressive androgen-independent prostate cancer.

- Determine the biodistribution and dosimetry of this antibody in these patients.

- Determine the effect on biodistribution of the delivery sequence of unlabeled vs indium
In 111-labeled antibody in these patients.

- Determine the HAHA response in patients treated with this regimen.

- Correlate the dose of monoclonal antibody huJ591 with antibody-dependent cellular
cytotoxicity in these patients.

OUTLINE: Patients are assigned to one of two treatment groups.

- Group I: Patients receive monoclonal antibody huJ591 IV followed by indium In 111
monoclonal antibody huJ591 on day 1.

- Group II: Patients receive monoclonal antibody huJ591 concurrently with indium In 111
monoclonal antibody huJ591 as in group I.

Treatment in both groups repeats every 3 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed for 4 weeks and then monthly for 3 months.

PROJECTED ACCRUAL: A total of 14 patients (7 per treatment group) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed prostate cancer

- Disease progression after prior castration

- At least 3 rising PSA levels at least 1 week apart OR 2 rising levels at least 4
weeks apart

- New osseous lesions on bone scan and/or more than 25% increase in bidimensionally
measurable soft tissue disease or appearance of new sites of disease by CT scan or
MRI

- Testosterone no greater than 50 ng/mL

- Medical therapy (e.g., gonadotropin-releasing hormone analogues) to maintain
castrate level of testosterone should continue in the absence of surgical
orchiectomy

- Progression of disease after discontinuation of prior anti-androgen therapy

- No requirement for palliative therapy within the past 12 weeks

- No active CNS or epidural primary tumor OR active CNS or epidural metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 3,500/mm3

- Platelet count greater than 100,000/mm3

Hepatic:

- Bilirubin less than 1.5 mg/dL

- Gamma-glutamyl-transferase less than upper limit of normal (ULN)

- AST less than ULN

- PT less than 14 seconds

- No prior autoimmune hepatitis

Renal:

- Creatinine less than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- No clinically significant cardiac disease (New York Heart Association class III or
IV)

Pulmonary:

- No severe debilitating pulmonary disease

Other:

- Fertile patients must use effective contraception

- No active uncontrolled infection or infection requiring IV antibiotics

- No prior autoimmune disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior murine protein for diagnostic or therapeutic purposes

- No other concurrent anticancer immunotherapy

Chemotherapy:

- At least 4 weeks since prior chemotherapy and recovered

- No concurrent anticancer chemotherapy

Endocrine therapy:

- See Disease Characteristics

- No concurrent anticancer hormonal therapy

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

- Concurrent radiotherapy to localized sites of disease (e.g., bone) allowed if the
site does not contain sole measurable lesion

Surgery:

- See Disease Characteristics

- No concurrent surgery

Other:

- Recovered from all prior therapy

- At least 4 weeks since prior therapeutic investigational anticancer drugs

- At least 4 weeks since prior participation in therapeutic clinical trial with an
experimental drug

- No prior diagnostic ProstaScint, Myoscint, or Oncoscint scans

- No other concurrent therapeutic investigational anticancer agents

- No concurrent participation in other therapeutic clinical trial with an experimental
drug

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael Morris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

MSKCC-01030

NCT ID:

NCT00024232

Start Date:

June 2001

Completion Date:

February 2004

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021