Monoclonal Antibody Therapy, Paclitaxel, and Cyclosporine in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
NCT ID: NCT00009776
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
INTERVENTIONAL
2001-03-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy combined with paclitaxel and cyclosporine in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.
Detailed Description
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* Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody Lym-1 in combination with paclitaxel and cyclosporine in patients with recurrent or refractory non-Hodgkin's lymphoma.
OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody Lym-1 (Y90 MOAB Lym-1).
Patients receive oral cyclosporine every 12 hours on days -2 to 14. Patients receive unlabeled MOAB Lym-1 IV followed by a tracer dose of indium In 111 MOAB Lym-1 IV on day 0. On day 7, patients receive unlabeled MOAB Lym-1 IV followed by Y90 MOAB Lym-1 IV. Patients in cohorts 2-4 also receive paclitaxel IV over 3 hours on day 9. Courses repeat every 8 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of Y90 MOAB Lym-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity.
Patients are followed monthly for 3 months, every 3 months for 21 months, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 36 months.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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monoclonal antibody Lym-1
cyclosporine
paclitaxel
indium In 111 monoclonal antibody Lym-1
yttrium Y 90 monoclonal antibody Lym-1
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of non-Hodgkin's lymphoma (NHL) that has failed standard first-line chemotherapy
* Measurable disease
* NHL tissue Lym-1 reactive in vitro
* Normocellular bone marrow as evidenced by less than 25% of the bone marrow being NHL by bilateral bone marrow biopsy
* No bone marrow evidence of myelodysplastic syndrome
* HAMA titer negative
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* 3 to 6 months
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 130,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* AST no greater than 84 U/L
Renal:
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min
Cardiovascular:
* LVEF at least 50%
Pulmonary:
* FEV1 at least 60% of predicted
* FVC at least 60% of predicted
* DLCO at least 50%
Other:
* No other prior malignancy within the past 5 years except for nonmelanoma skin cancer
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 4 weeks since prior external beam radiotherapy
Surgery:
* Not specified
18 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Principal Investigators
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Gerald L. DeNardo, MD
Role: STUDY_CHAIR
University of California, Davis
Locations
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University of California Davis Cancer Center
Sacramento, California, United States
Countries
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Other Identifiers
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UCD-991869
Identifier Type: -
Identifier Source: secondary_id
NCI-V00-1641
Identifier Type: -
Identifier Source: secondary_id
CDR0000068371
Identifier Type: -
Identifier Source: org_study_id