Radioimmunotherapy for Benign Conditions

Overseen By Phuong Vo

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Fred Hutchinson Cancer Center

Must not be taking: Antihypertensives, Cardiac medications

Disqualifiers: Fanconi anemia, HIV, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 5 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I/II trial studies the best dose of total body irradiation with astatine-211 BC8-B10 monoclonal antibody for the treatment of patients with nonmalignant diseases undergoing hematopoietic cell transplant. Radiation therapy uses high energy gamma rays to kill cancer cells and shrink tumors. Astatine-211-labeled BC8-B10 monoclonal antibody is a monoclonal antibody, called anti-CD45 monoclonal antibody BC8-B10, linked to a radioactive/toxic agent called astatine 211. Anti-CD45 monoclonal antibody BC8-B10 is attached to CD45 antigen positive cancer cells in a targeted way and delivers astatine 211 to kill them. Giving astatine-211 BC8-B10 monoclonal antibody and total-body irradiation before a donor stem cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells.

Who Is on the Research Team?

Phuong Vo

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adults under 50 with benign tumors treatable by stem cell transplant. They must have good performance scores, normal organ function, and a suitable donor (related or unrelated) matched to their HLA type. Pregnant or breastfeeding women, those unwilling to use contraception, and individuals with certain heart, lung, kidney or liver conditions are excluded.

Inclusion Criteria

DONOR INCLUSION

My donor matches me closely in immune system markers, with at most one mismatch allowed.

I am mostly active and can care for myself.

Exclusion Criteria

My heart function is normal, and I don't need medication for heart failure or uncontrolled high blood pressure.

My liver function is not severely impaired.

I am not willing to use birth control during and for a year after treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10, fludarabine, cyclophosphamide, thymoglobulin, and undergo total body irradiation and hematopoietic cell transplant

Approximately 5 weeks

Multiple visits for IV administration and procedures

Post-Transplant Medication

Participants receive mycophenolate mofetil and sirolimus to prevent graft-versus-host disease

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Periodic visits

What Are the Treatments Tested in This Trial?

Interventions

• Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10
• Total-Body Irradiation

Trial Overview The trial tests total body irradiation combined with Astatine-211-labeled BC8-B10 monoclonal antibody before hematopoietic cell transplantation in patients with nonmalignant diseases. It aims to find the best dose of radiation therapy that targets cancer cells without harming the patient's immune system.

How Is the Trial Designed?

Group I: Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) Experimental Treatment 10 Interventions

Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 IV on any day between days -10 and -7, fludarabine IV on days -6 to -2, cyclophosphamide IV over 1 hour on days -6 to -5 and 3 to 4, and thymoglobulin IV over 4-6 hours on days -4 to -2. Patients undergo TBI on day -1 and hematopoietic cell transplant on day 0. Beginning day 5, patients also receive mycophenolate mofetil PO or IV thrice daily every 8 hours up to day 35 if no GVHD present and sirolimus PO daily until day 365. Patients undergo blood sample collection and may undergo bone marrow aspiration throughout the study.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+