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PS-341 in Treating Patients With Advanced Cancer
This study is ongoing, but not recruiting participants.
Study NCT00006362   Information provided by National Cancer Institute (NCI)
First Received: October 4, 2000   Last Updated: November 16, 2008   History of Changes

October 4, 2000
November 16, 2008
November 1999
 
 
 
Complete list of historical versions of study NCT00006362 on ClinicalTrials.gov Archive Site
 
 
 
PS-341 in Treating Patients With Advanced Cancer
A Phase I and Pharmacologic Study of the Proteasome Inhibitor PS-341 in Patients With Advanced Solid Tumors and B-Cell Lymphoproliferative Disorders

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced cancer.

OBJECTIVES:

  • Determine the maximum tolerated dose and toxicity of PS-341 in patients with advanced malignancies.
  • Determine, in a preliminary manner, the therapeutic activity of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

  • Regimen A: Patients receive PS-341 IV twice weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3-4 or 2 of 6 patients experience dose-limiting toxicity.

  • Regimen B: Once the MTD has been determined in regimen A, patients receive PS-341 IV twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for 3 months.

PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 14 months.

Phase I
Interventional
Treatment
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Precancerous/Nonmalignant Condition
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: bortezomib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically proven advanced malignancy, including non-Hodgkin's lymphoma (NHL), for which there is no known standard therapy that is potentially curative or definitely capable of extending life expectancy

    • Patients with B-cell lymphoproliferative disorders and a leukemic phase are eligible once the maximum tolerated dose is established
  • NHL patients must meet the following conditions:

    • No greater than 25% of bone marrow involved
    • No symptomatic brain metastases
    • Prior brain metastases allowed if definitively treated (radiotherapy and/or surgery) and stable for at least 8 weeks

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 2.5 times ULN (5 times ULN if liver involvement)

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • No uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy or immunotherapy
  • No concurrent immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to greater than 30% of bone marrow
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent antiretroviral therapy (HAART) for HIV positive patients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006362
 
CDR0000068233, MAYO-980111, WCCC-CO-99904, NCI-T99-0071
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Alex A. Adjei, MD, PhD Mayo Clinic
National Cancer Institute (NCI)
April 2003

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