A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
17-N-allylamino-17-demethoxygeldanamycin/bortezomib
Hemic and Lymphatic Diseases+6
+ Hodgkin Disease
+ Immune System Diseases
Treatment Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.PRIMARY OBJECTIVES: I. To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkin's lymphoma using overall response rate as the primary efficacy endpoint. II. To assess time to progression and 2-year overall survival after bortezomib therapy. III. To evaluate the safety and tolerability of bortezomib in patients with relapsed/refractory Hodgkin's lymphoma. OUTLINE: This is a multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.43 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Histologically confirmed classical Hodgkin's lymphoma * No bone marrow biopsies or fine needle aspirates as the sole means of diagnosis * Core biopsies allowed if they contain adequate tissue for primary diagnosis * The following subtypes are allowed: * Nodular sclerosis * Lymphocyte rich * Mixed cellularity * Lymphocyte depletion * Classical Hodgkin's lymphoma, not otherwise specified * No nodular lymphocyte-predominant Hodgkin's lymphoma * Relapsed or refractory disease after at least 1 prior standard systemic cytotoxic chemotherapy regimen * Measurable disease by physical exam or imaging studies * Any tumor mass \> 1 cm is allowed * No non-measurable disease only, including the following: * Bone lesions * Ascites * Pleural or pericardial effusion * Lymphangitis cutis/pulmonis * Bone marrow * No curative option available with high-dose therapy and stem cell transplantation * Performance status - 0-2 * Absolute neutrophil count ≥ 750/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST ≤ 2.5 times ULN * Creatinine ≤ 2.5 mg/dL * No sensory or motor peripheral neuropathy ≥ grade 2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 3 months after study participation * See Disease Characteristics * Prior stem cell transplantation allowed * See Disease Characteristics * No concurrent chemotherapy * No concurrent dexamethasone or other steroidal antiemetics * Concurrent steroids for adrenal failure allowed * Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed * Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) is allowed provided other measurable disease is present * No concurrent palliative radiotherapy * Recovered from all prior treatment * No prior bortezomib or other proteosome inhibitors
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location