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Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00024232
First Posted: January 27, 2003
Last Update Posted: June 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center
September 13, 2001
January 27, 2003
June 18, 2013
June 2001
February 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00024232 on ClinicalTrials.gov Archive Site
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Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that has not responded to hormone therapy.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Prostate Cancer
Biological: monoclonal antibody huJ591
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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February 2004
February 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00024232
MSKCC-01030
CDR0000068903 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-G01-2013
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Michael Morris, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP