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PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma
This study has been completed.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: New York University School of Medicine
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004002
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer 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 solid tumors or lymphoma that have not responded to previous treatment.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: bortezomib
Phase I

MedlinePlus related topics: Cancer Intestinal Cancer Lymphoma
Drug Information available for: Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Trial of PS-341 in Advanced Cancers

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

Study Start Date: July 1999
Detailed Description:

OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of PS-341 in patients with advanced solid tumors or lymphoma. II. Evaluate the pharmacodynamics of this drug by measuring 20S proteasome inhibition in these patients. III. Assess changes in P53 or P27, and possibly E2F-1 and cyclin E, in patients with lymphoma in response to this drug. IV. Evaluate objective tumor response to this drug in these patients. V. Evaluate the relationship between toxicity and 20S proteasome inhibition in blood and in accessible tumor tissue in these patients. VI. Evaluate response to treatment with this drug in patients with measurable or evaluable disease.

OUTLINE: This is a dose-escalation, multicenter study. Patients receive PS-341 IV on days 1 and 4. Treatment repeats every 14 days for at least 2 courses in the absence of unacceptable toxicity or disease progression. Patients with stable or responding disease may receive additional courses at the discretion of the treating physician. 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 at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor or lymphoma that has failed standard therapy and no standard options available No leukemia or myeloma CNS lesions allowed if adequately treated by surgery and/or radiotherapy and symptomatically stable on maintenance glucocorticoids and not requiring anticonvulsants for at least 3 months

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 2.5 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No acute ischemia or significant conduction abnormality (i.e., bifascicular block or 2nd or 3rd degree AV blocks) Other: No other serious medical or psychiatric illness Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation with high-dose chemotherapy or radiolabeled monoclonal antibody therapy for lymphoma patients Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 2 weeks since prior major surgery Other: See Disease Characteristics No concurrent antiretroviral therapy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004002

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Chair: Franco M. Muggia, MD New York University School of Medicine
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067212, NYU-9909, NCI-T99-0047
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004002     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
small intestine lymphoma
unspecified adult solid tumor, protocol specific
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
stage IV adult T-cell leukemia/lymphoma
recurrent adult T-cell leukemia/lymphoma
primary central nervous system lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
intraocular lymphoma

Study placed in the following topic categories:
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Ileal Diseases
Follicular Lymphoma
Duodenal Neoplasms
Mycoses
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Protease Inhibitors
B-cell Lymphomas
Leukemia, T-Cell
Gastrointestinal Neoplasms
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Gastrointestinal Diseases
Lymphoma, Follicular
Central Nervous System Lymphoma, Primary
Lymphoma, B-Cell, Marginal Zone
Sezary Syndrome
Mycosis Fungoides
Lymphoblastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia
Ileal Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Ileal Diseases
Duodenal Neoplasms
Neoplasms by Site
Ileal Neoplasms
Jejunal Diseases
Therapeutic Uses
Lymphoma
Duodenal Diseases
Jejunal Neoplasms
Digestive System Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Bortezomib
Enzyme Inhibitors
Intestinal Diseases
Intestinal Neoplasms
Pharmacologic Actions
Protease Inhibitors
Lymphatic Diseases
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 07, 2009