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Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00028613   Information provided by National Cancer Institute (NCI)
First Received: January 4, 2002   Last Updated: February 6, 2009   History of Changes

January 4, 2002
February 6, 2009
March 2001
 
 
 
Complete list of historical versions of study NCT00028613 on ClinicalTrials.gov Archive Site
 
 
 
Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma
Phase I Safety Study Of 131I-Lym-1 For The Treatment Of Previously Treated Diffuse Large B-Cell Lymphoma

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.

OBJECTIVES:

  • Determine the maximum tolerated dose of iodine I 131 monoclonal antibody Lym-1 in patients with previously treated diffuse large cell lymphoma.
  • Determine the safety of this drug in these patients.
  • Determine the response of patients to this drug.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive unlabeled monoclonal antibody Lym-1 IV over 40 minutes followed 15-30 minutes later by iodine I 131 monoclonal antibody Lym-1 IV over 2 minutes.

Cohorts of 3-6 patients receive escalating doses of iodine I 131 monoclonal antibody Lym-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed weekly for 8 weeks and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 8-36 patients will be accrued for this study.

Phase I
Interventional
Treatment
Lymphoma
Radiation: iodine I 131 monoclonal antibody Lym-1
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed B-cell diffuse large cell lymphoma

    • L-26 positive (i.e., CD20-positive)
  • Failed 2 prior chemotherapy regimens
  • At least 1 measurable lesion

    • At least 2 cm by physical exam or CT scan
  • No active lymphomatous meningitis or other CNS involvement by lymphoma
  • No significant marrow involvement (i.e., more than 20% of hematopoietic marrow elements from iliac crest biopsy)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 3,500/mm3
  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 125,000/mm3

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST/ALT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN

Renal:

  • Creatinine no greater than 2 times ULN

Cardiovascular:

  • No electrocardial evidence of Q-wave myocardial infarction within the past 6 months
  • No congestive heart failure
  • No New York Heart Association class III or IV heart disease

Other:

  • HIV negative
  • Negative human anti-mouse antibodies (i.e., less than 74 ng/mL)
  • No known antiplatelet antibodies
  • No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior bone marrow or peripheral blood stem cell transplantation
  • No prior radioimmunotherapy
  • Prior unlabeled monoclonal antibody therapy allowed
  • At least 120 hours since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • At least 1 month since prior epoetin alfa

Chemotherapy:

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Biologic therapy
  • No prior total body irradiation (TBI)
  • At least 6 months since prior radiotherapy (over 3,00 cGy) to more than 20% of marrow-bearing space (i.e., pelvis and spine)
  • No concurrent large-field radiotherapy (i.e., TBI, hemibody radiation, or radiation fields that include more than 20% of active marrow to a dose of over 3,000 cGy)
  • Concurrent localized radiotherapy is allowed to current or impending serious complication (e.g., bronchial obstruction by hilar lymph nodes or impending fracture due to lytic bone lesions)

Surgery:

  • Not specified

Other:

  • Recovered from prior anti-lymphoma therapy
  • At least 120 hours since prior whole blood or platelet transfusion
  • No concurrent anticoagulants or antiplatelet drugs
  • No concurrent medications known to inhibit blood clotting or platelet aggregation (e.g., aspirin)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00028613
 
CDR0000069110, CWRU-BRLX-1400, BRLX-303680, CWRU-090036, NCI-G01-2038
Ireland Cancer Center
National Cancer Institute (NCI)
Study Chair: Omer N. Koc, MD Case Comprehensive Cancer Center
National Cancer Institute (NCI)
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP