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

NCT00860171 | Terminated Phase 1 Results DMC

• 4 other identifiers: 2238.00NCI-2010-00128P01CA044991P30CA015704
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent B-Cell Non-Hodgkin Lymphoma; Recurrent Hodgkin Lymphoma; Recurrent T-Cell Non-Hodgkin Lymphoma; Refractory B-Cell Non-Hodgkin Lymphoma; Refractory Hodgkin Lymphoma; Refractory T-Cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD) of I-131-BC8 That Can be Delivered Prior to Transplant

  Dose escalation/de-escalation will be conducted by the "two-stage" approach introduced by Storer. Escalation will continue until a dose-limiting toxicity (DLT) occurs. A DLT will be defined as a therapy-related grade III or IV Bearman (transplant) toxicity. The MTD is estimated to be the dose that is associated with a toxicity rate of 25% (Bearman grade 3-4).

  Within 30 days post-transplant

• I-131 Activity Administered

  At time of I-131 therapy

Secondary Outcomes (4)

• Adverse Events

  Up to 6 years

• Overall Survival

  Up to 6 years

• Progression-free Survival

  Up to 6 years

• Relapse Rate

  Up to 6 years

Study Arms (1)

Treatment (iodine I 131 monoclonal antibody B, autologous HCT)

EXPERIMENTAL

Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.

Procedure: Autologous Hematopoietic Stem Cell Transplantation; Radiation: Iodine I 131 Monoclonal Antibody BC8; Other: Laboratory Biomarker Analysis

Interventions

Autologous Hematopoietic Stem Cell Transplantation PROCEDURE

Autologous stem cells given via central catheter

Also known as: Autologous Stem Cell Transplantation

Treatment (iodine I 131 monoclonal antibody B, autologous HCT)

Iodine I 131 Monoclonal Antibody BC8 RADIATION

Given IV

Also known as: I 131 MOAB BC8, I 131 Monoclonal Antibody BC8, iodine I 131 MOAB BC8, MOAB BC8, iodine I 131, monoclonal antibody BC8, iodine I 131

Treatment (iodine I 131 monoclonal antibody B, autologous HCT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (iodine I 131 monoclonal antibody B, autologous HCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 must have received at least one prior standard systemic therapy with documented recurrent or refractory disease
• Mantle cell lymphoma (MCL), T-NHL, or other high-risk malignancies may be enrolled/transplanted in complete remission (CR)/first partial remission (PR1)
• 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
• Bilirubin \< 1.5 mg/dL, with the exception of patients thought to have Gilbert's syndrome, who may have a total bilirubin above 1.5 mg/dL
• All patients eligible for therapeutic study must have a minimum of \>= 4 x10\^6 CD34/kg autologous hematopoietic stem cells harvested and cryopreserved and divided into 2 aliquots of at least \>= 2 x10\^6 CD34/kg each; patients with a history of prior autologous hematopoietic cell transplant (HCT) are only required to have \>= 2x10\^6 CD34/kg stored
• Patients must have an expected survival of \> 60 days and must be free of major infection

You may not qualify if:

• Circulating human anti-mouse antibody (HAMA), to be determined before each infusion
• Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled therapy dose with the exception of rituximab
• Inability to understand or give an informed consent
• Lymphoma involving the central nervous system
• 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.)
• Known human immunodeficiency virus (HIV) seropositivity
• Pregnancy or breast feeding
• Prior allogeneic bone marrow or stem cell transplant
• Prior autologous bone marrow or stem cell transplant or prior radiation therapy (RT) \> 20 Gy to a critical organ within 1 year of enrollment
• Presence of 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 stem cells which are negative \[=\< 0.1% involved\] by flow cytometry will also be considered eligible)
• Southwest Oncology Group (SWOG) performance status \>= 2.0
• Unable to perform self-care during radiation isolation
• Expected survival if untreated less than 60 days

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Hodgkin Disease; Lymphoma, T-Cell

Interventions

Iodine-131

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

This protocol was closed to enrollment when replaced by a newer approach.

Results Point of Contact

• Title: Ajay K. Gopal, MD
• Organization: Fred Hutchinson Cancer Research Center

agopal@u.washington.edu

206-288-2037

Study Officials

• Ajay Gopal

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: A single site, open label clinical trial.

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2015
• Study Completion: March 21, 2020
• Last Updated: April 3, 2020
• Results First Posted: October 12, 2017

Record last verified: 2019-08

Locations

US (1)