NCT00028613

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances such as radioactive iodine to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibodies in treating patients who have large cell lymphoma that has been previously treated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1 lymphoma

Timeline
Completed

Started Mar 2001

Shorter than P25 for phase_1 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

June 30, 2003

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

7 months

First QC Date

January 4, 2002

Last Update Submit

January 8, 2014

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphoma

Interventions

iodine I 131 monoclonal antibody Lym-1RADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic diagnosis of B-cell diffuse large cell lymphoma (REAL classification system) confirmed by an independent central pathology reviewer.
  • The tumor's B-cell phenotype will be confirmed by positive L-26 (CD20).
  • Previous treatment with 2 common combination chemotherapy regimens. Patients previously treated with unlabeled monoclonal antibody therapy are eligible.
  • Men or women at least 18 years of age.
  • Karnofsky Performance Score (KPS) estimated to be \> 60 at the time of the scheduled therapeutic dose of 131I-Lym-1.
  • Life expectancy estimated to be at least 3 months from the time of the therapeutic dose of 131I Lym-1.
  • Measurable disease demonstrable by physical examination or computerized tomography (CT).
  • CT scan evidence of at least one indicator lesion with at least one diameter that measures \> 2 cm. (The CT scan should be done within 2 weeks of the imaging study.)

You may not qualify if:

  • Inability or unwillingness to comply with the following:
  • Bone marrow biopsy
  • Return for follow-up visits
  • Remaining motionless for extended periods of time for imaging procedures
  • Serial blood/urine sampling (for dosimetry patients only)
  • Pregnancy (Women of childbearing potential must be practicing an effective method of contraception.)
  • Presence of a second malignancy except for basal cell skin carcinoma or carcinoma in-situ of the cervix
  • Presence of active lymphomatous meningitis or other CNS involvement with lymphoma.
  • HIV positive patients.
  • Prior total body irradiation, or a course of prior radiation \> 3,000 cGy delivered to \> 20% of the central marrow or the lumbar vertebrae within 6 months of screening.
  • Serum creatinine or total bilirubin \> 2 x the upper limit of normal.
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase \> 3 x the upper limit of normal.
  • Significant marrow lymphoma (defined as lymphoma cells constituting greater than 20% of the hematopoietic marrow elements from an iliac crest biopsy). A prior bone marrow biopsy is acceptable if it meets the following criteria:
  • If there is prior bone marrow involvement, the biopsy must be performed within 45 days of screening.
  • If there is no prior bone marrow involvement, the biopsy must be performed within 90 days of screening
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-Hodgkin

Study Officials

  • Omer N. Koc, MD

    Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2002

First Posted

June 30, 2003

Study Start

March 1, 2001

Primary Completion

October 1, 2001

Study Completion

October 1, 2001

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

US(1)