Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00082966
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	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

Detailed Description

PRIMARY OBJECTIVES:

1. To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkin's lymphoma using overall response rate as the primary efficacy endpoint.

2. To assess time to progression and 2-year overall survival after bortezomib therapy.

3. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
• Study Start Date: Mar 1, 2004
• Actual Primary Completion Date: Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Overall response rate [Up to 3 years]

2. Time to progression [Up to 5 years]

3. Overall survival [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Cancer and Leukemia Group B	Chicago	Illinois	United States	60606

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Nancy Bartlett, Cancer and Leukemia Group B

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00082966
• Other Study ID Numbers: NCI-2012-01812; CALGB-50206; CDR0000361745; U10CA031946
• First Posted: May 17, 2004
• Last Update Posted: Dec 4, 2015
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease; Bortezomib

Study Results

No Results Posted as of Dec 4, 2015