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SCCA Lymphoma Clinical Trials

Iodine I 131 Monoclonal Antibody BC8 + Autologous SCT for Relapsed Lymphoma (FH-2238)
A Study Evaluating Escalating Doses of 131I-BC8 (anti-CD45) Antibody Followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies
Status Conditions Phase Study ID
Open Lymphoma Phase I FH-2238
NCT00860171
Summary

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving iodine I 131 monoclonal antibody BC8 before an autologous stem cell transplant may be an effective treatment for lymphoma.

PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given before an autologous stem cell transplant in treating patients with lymphoma that has relapsed or not responded to treatment.


Investigator
Ajay Gopal, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed lymphoma, including 1 of the following:

    • B-cell or T-cell non-Hodgkin lymphoma (NHL)

      • Documented CD45 antigen expression in tumor specimens
    • Hodgkin lymphoma

      • Must have CD45+ cells adjacent to the Reed Sternberg cells
  • Must have received at least 1 prior standard systemic therapy AND have documented recurrent or refractory disease

    • Patients with mantle cell lymphoma or other high-risk NHL (e.g., T-cell NHL) may be in first complete remission or partial remission
  • Meets 1 of the following criteria:

    • Tumor mass amenable to core needle biopsy during the dosimetry phase
    • Measurable tumor mass with ≥ 1 site of involvement measuring 2.0 cm in largest dimension on CT imaging (for purposes of planar and/or SPECT/CT imaging tumor dosimetry)

      • Disease that does not allow tumor dosimetry allowed
  • No circulating lymphoma cells by morphology or flow cytometry (> 0.1%) at or near the time of peripheral blood stem cell (PBSC) collection (if unpurged/unselected PBSC are to be used)

    • Patients with cryopreserved PBSC that are negative (≤ 0.1%) by flow cytometry are eligible
  • Must have ≥ 4x 10^6 CD34/kg autologous hematopoietic stem cells (HSC) available

    • Patients who underwent prior autologous HSC transplantation must have ≥ 2 x 10^6 CD34/kg autologous HSC available
  • No CNS lymphoma
Last Updated
November 07, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.