Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer
This study has been completed.
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00058409
  Purpose

RATIONALE: Monoclonal antibodies such as MLN2704 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effect of MLN2704 on the body in treating patients who have progressive metastatic prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: MLN2704
Phase I

Genetics Home Reference related topics: myotonic dystrophy
MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase I Single Ascending Dose Trial of MLN2704 (DM1 Conjugated Monoclonal Antibody MLN591) in Subjects With Metastatic Androgen Independent Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2002
Detailed Description:

OBJECTIVES:

  • Determine the dose-limiting toxicity and maximum tolerated dose of MLN2704 immunoconjugate in patients with progressive metastatic androgen-independent prostate cancer.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the prostate-specific antigen and disease response in patients treated with this drug.
  • Determine the anti-MLN591 antibody and anti-MLN2704 antibody response to this drug in these patients.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive MLN2704 IV over 2.5 hours on day 1. Treatment repeats every 6-8 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients with responsive disease after 3 doses of therapy may receive additional therapy as above at the investigator's discretion.

Cohorts of 3-6 patients receive escalating doses of MLN2704 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study within 1 year.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate adenocarcinoma

    • Metastatic disease
  • Progressive disease by physical exam, imaging studies, and/or rising prostate-specific antigen (PSA) levels defined by at least 1 of the following criteria*:

    • Progressive tumor lesions (changes in the size of lymph nodes or parenchymal masses on physical exam or x-ray and CT scan or MRI)
    • Progressive bone metastases (presence of new lesion[s] on a bone scan)
    • Progressive PSA levels despite castrate levels of testosterone

      • PSA at least 5 ng/mL
    • Progression of disease demonstrated after completion of antiandrogen therapy NOTE: *Patients whose sole manifestation of progressive disease is an increase in disease-related symptoms are not eligible
  • Measurable or evaluable disease
  • Failed prior hormonal therapy (including antiandrogen withdrawal therapy)
  • No history of CNS metastasis (including epidural disease)

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 6 months

Hematopoietic

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hematocrit greater than 30%
  • No serious hematologic illness that would preclude study completion or interfere with determination of causality of study adverse events

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST or ALT no greater than 1.5 times ULN
  • PTT normal
  • PT and INR normal
  • No serious hepatic illness that would preclude study completion or interfere with determination of causality of study adverse events

Renal

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • Calcium less than 12.5 mg/dL
  • No serious renal illness that would preclude study completion or interfere with determination of causality of study adverse events

Cardiovascular

  • No history of stroke
  • No active angina pectoris
  • No New York Heart Association class III or IV heart disease
  • No serious cardiac illness that would preclude study completion or interfere with determination of causality of study adverse events

Pulmonary

  • No serious respiratory illness that would preclude study completion or interfere with determination of causality of study adverse events

Other

  • Fertile patients must use effective barrier contraception
  • HIV negative
  • No history of seizure disorder requiring active treatment
  • No serious CNS illness that would preclude study completion or interfere with determination of causality of study adverse events
  • No grade 2 or greater peripheral neuropathy
  • No active serious infection not controlled by antibiotics
  • No other serious illness that would preclude study completion or interfere with determination of causality of study adverse events

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior monoclonal antibody therapy (including Prostacint®)
  • No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or other white cell colony-stimulating factors, except for febrile neutropenia
  • No concurrent interleukin-11 for platelet count support

Chemotherapy

  • More than 6 weeks since prior cytotoxic chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • More than 4 weeks since prior corticosteroids and/or adrenal hormone inhibitors
  • More than 6 weeks since prior antiandrogen therapy (e.g., flutamide, bicalutamide, or nilutamide)
  • No prior finasteride (Proscar® or Propecia®)
  • Luteinizing hormone-releasing hormone (LHRH) analog therapy allowed if 1 of the following circumstances exists:

    • If patient is currently receiving LHRH analog therapy, therapy must be maintained for study duration
    • If patient discontinued LHRH analog therapy prior to study entry, therapy must be discontinued at least 10 weeks prior to study entry for 1-month depot preparations, 24 weeks for 3-month depot preparations, or 32 weeks for 4-month depot preparations

Radiotherapy

  • More than 6 weeks since prior radiotherapy

Surgery

  • Not specified

Other

  • More than 4 weeks since prior PC-SPES
  • No other concurrent medication for platelet count support
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058409

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Howard I. Scher, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000288829, MSKCC-02099, MILLENNIUM-M59102-042
Study First Received: April 7, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00058409  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Genital Neoplasms, Male
Prostatic Diseases
Urogenital Neoplasms
Genital Diseases, Male
Dystrophia myotonica 1
Recurrence
Antibodies, Monoclonal
Myotonia atrophica
Antibodies
Myotonic Dystrophy
Adenocarcinoma
Prostatic Neoplasms
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009