Clinical trial NCT00082966: Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Official title: A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult Lymphocyte Depletion Hodgkin Lymphoma
Adult Mixed Cellularity Hodgkin Lymphoma
Adult Nodular Sclerosis Hodgkin Lymphoma
Recurrent Adult Hodgkin Lymphoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-05-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Overall response rate
timeFrame: Up to 3 years
measure: Time to progression
timeFrame: Up to 5 years
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Cancer and Leukemia Group B
state: Illinois
Study officials:
affiliation: Cancer and Leukemia Group B
name: Nancy Bartlett
role: PRINCIPAL_INVESTIGATOR
References: