A Trial of MLN2704 in Subjects With Metastatic Androgen Independent Prostate Cancer

NCT ID: NCT00052000

Last Updated: 2007-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30

Brief Summary

This is the first study of MLN2704 administered to humans. The purpose of the study is to determine the highest dose of MLN2704 that can be given safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up (absorbed), broken down (metabolized) and eliminated (excreted) by the body. This process is called pharmacokinetic analysis.

Detailed Description

This is a Phase 1 open-label dose-escalating trial designed to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and pharmacokinetics of a single dose of MLN2704 in subjects with metastatic androgen-independent prostate cancer.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MLN2704 (DM1 conjugated monoclonal antibody MLN591)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologic diagnosis (recent or remote) of prostate adenocarcinoma
• Progressive prostate cancer on physical exam, imaging studies and/or rising PSA, as defined by the presence of one or more of the following:

• Progressive tumor lesions (changes in the size of lymph nodes or parenchymal masses on physical examination or X-ray and CT scan or MRI)
• Progressive bone metastasis (presence of new lesion(s) on a bone scan)
• Progressive PSA levels despite castrate levels of testosterone
• Patients who have received an anti-androgen must have shown progression of disease off of the anti-androgen prior to enrollment
• Failed hormonal therapy (including anti-androgen withdrawal therapy, as appropriate)
• LHRH (Luteinizing Hormone-Releasing Hormone)analog therapy:
• If subject is being treated with LHRH analog therapy at the time of screening the therapy must be maintained for the duration of the trial.
• If subject discontinued LHRH therapy prior to screening, the therapy must be discontinued ≥10 weeks prior to enrollment for 1 month depot preparations, 24 weeks for 3 month depot preparations, and 32 weeks for 4 month depot preparations.
• Agree to use an effective method of barrier contraception. Effective method of barrier contraception includes a condom with spermicidal jelly, a diaphragm with spermicidal jelly, or abstinence.

Exclusion Criteria

• Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of enrollment
• Use of PC-SPES (herbal supplement) within 4 weeks of enrollment
• Prior cytotoxic chemotherapy and/or radiation therapy within 6 weeks of enrollment
• Use of anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) within 6 weeks of enrollment
• Prior monoclonal antibody administration, including Prostacint®
• Peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (NCI CTC)
• History of CNS metastasis, including epidural disease
• History of seizure disorder requiring active treatment and/or stroke
• History of HIV infection
• Platelet count ≤100,000/mm3
• Absolute neutrophil count (ANC) ≤1,500/mm3
• Hematocrit ≤30 percent
• Abnormal coagulation profile (PT, and/or INR, PTT)
• Creatinine clearance <60 mL/min or Serum creatinine >2.0 mg/dL
• AST or ALT >1.5 X ULN
• Bilirubin (total) >ULN
• Serum calcium ≥12.5 mg/dL
• Active serious infection not controlled by antibiotics
• Active angina pectoris or NY Heart Association Class III-IV heart disease
• Karnofsky Performance Status <60
• Life expectancy <6 months
• Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems that might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Locations

The Sidney Kimmel Comprehensive Cancer Center @ Johns Hopkins

Baltimore, Maryland, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

M59102-042

Identifier Type: -

Identifier Source: org_study_id

NCT00058409

Identifier Type: -

Identifier Source: nct_alias