Status:
COMPLETED
Velcade Plus ICE for Patients With Relapsed Classical Hodgkin Lymphoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Hodgkin Lymphoma
Lymphoma
Eligibility:
All Genders
16+ years
Phase:
PHASE1
Brief Summary
Primary Objectives: 1. To determine the toxicity profile of multiple doses of bortezomib when given with ICE in patients with relapsed and refractory classical Hodgkin lymphoma (HL). 2. To determine ...
Detailed Description
Bortezomib is designed to block a protein that plays a role in cell function and growth, which may cause cancer cells to die. ICE is a combination of chemotherapy drugs that, together, may work more ...
Eligibility Criteria
Inclusion
- Histologically confirmed relapsed or refractory classical Hodgkin lymphoma (nodular sclerosis, mixed cellularity, or lymphocyte-rich classical HL).
- Patients must have failed front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
- Bidimensionally measurable disease with at least 1 lesion \>/= 2.0 cm in a single dimension
- Acceptable hematologic status: Hemoglobin \>/= 8.0 g/dL; Absolute neutrophil count \>/= 1500 cells/mm\^3; Platelet count \>/= 100,000 cells/mm\^3
- Pre-study World Health Organization (WHO) performance status of 0, 1, or 2
- Age greater than or equal to 16 years
- Voluntary signed IRB approved consent informed before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Patients of reproductive potential must follow accepted birth control methods during treatment and for 3 months after completion of treatment. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study. Female patients must not be pregnant or lactating.
Exclusion
- Lymphocyte predominant histology
- More than one prior chemotherapy regimen.
- Prior stem cell transplant
- Abnormal liver function:Bilirubin \> 2.0 mg/dL (26 µmol/L); Alkaline phosphatase \> 2 \* upper limits of normal (ULN); AST (SGOT) \> 2 \* ULN
- Serum creatinine \> 1.5 mg/dL (177 µmol/L) within 14 days before enrollment
- Presence of CNS involvement with Hodgkin lymphoma
- Presence of HIV infection or AIDS
- Patient has \>/= Grade 2 peripheral neuropathy within 14 days before enrollment.
- Patient has hypersensitivity to boron or mannitol.
- Prior bortezomib therapy.
- Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable PSA) for which the patient has not been disease-free for at least 3 years
- Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions which would compromise protocol objectives in the opinion of the investigator and/or the sponsor.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00439361
Start Date
February 1 2007
End Date
June 1 2012
Last Update
July 9 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030