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

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.


Condition Intervention Phase
Lymphoma
Radiation: iodine I 131 monoclonal antibody Lym-1
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Safety Study Of 131I-Lym-1 For The Treatment Of Previously Treated Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028613

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Omer N. Koc, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069110, CWRU-BRLX-1400, BRLX-303680, CWRU-090036, NCI-G01-2038
Study First Received: January 4, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00028613     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma

Study placed in the following topic categories:
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Immunologic Factors
Recurrence
Lymphoma, B-Cell
Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
B-cell Lymphomas
Iodine
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma, Large-cell
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Lymphoma, B-Cell
Antibodies, Monoclonal
Lymphatic Diseases
Neoplasms
Antibodies
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on July 02, 2009