Status:
TERMINATED
Bortezomib and Ganciclovir in Treating Patients With Relapsed or Refractory Epstein Barr Virus-Positive Lymphoma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Lymphoma
Lymphoproliferative Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Epstein Barr virus can cause cancer and lymphoproliferative disorders. Ganciclovir is ...
Detailed Description
OBJECTIVES: Primary * Maximum Tolerated Dose (MTD) of bortezomib in patients with relapsed or refractory Epstein Barr virus-positive lymphoma. Secondary * Assess the antitumor effect of this regim...
Eligibility Criteria
Inclusion
- Histologically confirmed Epstein Barr virus-positive lymphoma, including the following subtypes:
- Post-transplantation lymphoma
- Burkitt's lymphoma
- Hodgkin's lymphoma
- T-/NK-cell lymphoma
- Unresponsive to, or relapsed after, at least 1 prior chemotherapy regimen
- Bidimensionally measurable disease by CT scan
- At least 1 lesion ≥ 1.5 cm in the greatest diameter
- Age 18 and over
- ECOG 0-2 OR
- Karnofsky 50-100%
- Life expectancy More than 3 months
- Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm\^3 (no growth factor support within the past 4 weeks)
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 50,000/mm\^3 (no platelet transfusions within the past 4 weeks)
- Hepatic
- Bilirubin ≤ 2.0 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN (5 times ULN in patients with liver involvement)
- No active hepatitis B or C
- Renal
- Creatinine clearance ≥ 60 mL/min
- Sodium \> 130 mmol/L
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- At least 4 weeks since prior immunotherapy
- At least 4 weeks since prior chemotherapy
- At least 4 weeks since prior radiotherapy
- More than 4 weeks since prior major surgery unless fully recovered
- Recovered from all prior therapy
- At least 4 weeks since prior investigational agents
Exclusion
- primary or secondary CNS lymphoma or HIV-related lymphoma
- known brain metastases
- myocardial infarction within the past 6 months
- acute ischemia or new conduction system abnormalities by electrocardiogram
- symptomatic congestive heart failure
- unstable angina pectoris
- cardiac arrhythmia
- hospitalized
- pregnant or nursing
- other uncontrolled illness
- ongoing or active systemic infection
- psychiatric illness or social situation that would preclude study compliance
- history of allergic reaction attributable to compounds of similar chemical or biological composition to study drugs
- sensitivity to boron, mannitol, bortezomib, or ganciclovir
- concurrent corticosteroids (≥ 10 mg of prednisone or equivalent)
- concurrent radiotherapy
- other concurrent anticancer therapy
- other concurrent investigational agents
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00093704
Start Date
March 1 2005
Last Update
July 31 2020
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781