Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Lymphocyte Depletion Hodgkin Lymphoma Adult Mixed Cellularity Hodgkin Lymphoma Adult Nodular Sclerosis Hodgkin Lymphoma Recurrent Adult Hodgkin Lymphoma |
Drug: 17-N-allylamino-17-demethoxygeldanamycin/bortezomib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A PHASE II STUDY OF PS-341 (BORTEZOMIB) IN PATIENTS WITH RELAPSED OR REFRACTORY HODGKINâS LYMPHOMA |
- Overall response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 43 |
| Study Start Date: | March 2004 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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.
|
Drug: 17-N-allylamino-17-demethoxygeldanamycin/bortezomib
Given IV
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00082966 History of Changes |
| Other Study ID Numbers: | NCI-2012-01812, CALGB-50206, U10CA031946, CDR0000361745 |
| Study First Received: | May 14, 2004 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Sclerosis Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Pathologic Processes Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013