Clinical Trial · NCT00860171

Iodine I 131 Monoclonal Antibody BC8 Before Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

Overview

This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given before autologous stem cell transplant in treating patients with Hodgkin lymphoma or non-Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment. 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 kill more cancer cells.

Sponsor

Fred Hutchinson Cancer Center

Phase

Phase 1

Contacts

Ajay Gopal (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00860171

Drug / Compound

BC8

Isotope(s):

Target(s):

CD45

Ligand Class: Antibodies

Eligibility

Inclusion

Patients must have received at least one prior standard systemic therapy with documented recurrent or refractory disease
* Patients must have a histologically confirmed diagnosis of B-NHL, T-NHL, or HL; CD45 antigen expression must be documented on tumor specimens in all cases except HL, in whom histologic demonstration of CD45+ cells adjacent to the Reed Sternberg cells is required
Patients are preferred to have either a tumor mass amenable to core needle biopsy during the dosimetry phase, or a measurable tumor mass with at least one site of involvement measuring 2.0 cm in largest dimension on computed tomography (CT) imaging for purposes of planar and/or single-photon emission CT (SPECT)/CT tumor dosimetry (patients with disease that does not allow tumor dosimetry will be allowed on study since they still can contribute toward achieving the primary endpoint, but these patients will be given a lower priority over those with evaluable disease)
Creatinine \[Cr\] \< 2.0
Mantle cell lymphoma (MCL), T-NHL, or other high-risk malignancies may be enrolled/transplanted in complete remission (CR)/first partial remission (PR1)

Exclusion

Other serious medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g. abnormally decreased cardiac ejection fraction, diffusion capacity of the lung for carbon monoxide (DLCO) \< 50% predicted, forced expiratory volume in one second (FEV1) \< 70% predicted, acquired immune deficiency syndrome \[AIDS\], etc.)
* Circulating human anti-mouse antibody (HAMA), to be determined before each infusion
Inability to understand or give an informed consent
Lymphoma involving the central nervous system
Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled therapy dose with the exception of rituximab