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| ID | Type | Description | Link |
|---|---|---|---|
| CALGB-50206 | |||
| CDR0000361745 | |||
| U10CA031946 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17-N-allylamino-17-demethoxygeldanamycin/bortezomib | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Up to 3 years | |
| Time to progression | Up to 5 years | |
| Overall survival | 2 years |
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Inclusion Criteria:
Histologically confirmed classical Hodgkin's lymphoma
The following subtypes are allowed:
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:
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 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
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Bartlett | Cancer and Leukemia Group B | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer and Leukemia Group B | Chicago | Illinois | 60606 | United States |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C112765 | tanespimycin |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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