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Monoclonal Antibody Therapy, Paclitaxel, and Cyclosporine in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
monoclonal antibody Lym-1
cyclosporine
paclitaxel
indium In 111 monoclonal antibody Lym-1
yttrium Y 90 monoclonal antibody Lym-1
Sponsored by
University of California, Davis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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

Sites / Locations

  • University of California Davis Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
September 19, 2013
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00009776
Brief Title
Monoclonal Antibody Therapy, Paclitaxel, and Cyclosporine in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
Official Title
Combined Modality Radioimmunotherapy For Non-Hodgkin's Lymphoma With Three Cycles Of 90Y-DOTA-peptide-Lym-1, Paclitaxel and Cyclosporin A
Study Type
Interventional

2. Study Status

Record Verification Date
October 2001
Overall Recruitment Status
Unknown status
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Davis

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with cyclosporine and paclitaxel may be an effective treatment for non-Hodgkin's lymphoma. 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
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
monoclonal antibody Lym-1
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Radiation
Intervention Name(s)
indium In 111 monoclonal antibody Lym-1
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 monoclonal antibody Lym-1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald L. DeNardo, MD
Organizational Affiliation
University of California, Davis
Official's Role
Study Chair
Facility Information:
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Monoclonal Antibody Therapy, Paclitaxel, and Cyclosporine in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma

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