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

September 19, 2013 updated by: University of California, Davis

Combined Modality Radioimmunotherapy For Non-Hodgkin's Lymphoma With Three Cycles Of 90Y-DOTA-peptide-Lym-1, Paclitaxel and Cyclosporin A

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • University of California Davis Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

October 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068371
  • UCD-991869
  • NCI-V00-1641

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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