TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis

Study Purpose

This early phase I trial studies the side effects and feasibility of total body irradiation using intensity modulation radiation therapy (IMRT) when given in combination with cyclophosphamide prior to stem cell transplant to treat severe systemic sclerosis. IMRT delivers total body radiation therapy more precisely and may reduce radiation exposure to sensitive normal organs. Giving chemotherapy, such as cyclophosphamide, and total body irradiation before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the bone marrow for new blood-forming cells (stem cells) to grow. Giving IMRT and cyclophosphamide prior to stem cell transplant may work better in treating severe systemic sclerosis and reduce radiation doses to lung and kidneys compared to cyclophosphamide alone.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Karnofsky performance status (KPS) >= 70 - Systemic sclerosis patients evaluated within 30 days of start of conditioning regimen who would be candidates for TBI-cyclophosphamide (Cy) per City of Hope (COH) guidelines and standard operating procedures (SOP) for autologous hematopoietic cell transplant - Patients must be suitable for TBI conditioning regimens as part of transplant per radiation the referring hematologist - Patients must have adequate organ function for HCT as determined by the hematologist - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation - All subjects must have the ability to understand the treatment and the willingness to sign a written informed consent

Exclusion Criteria:

- Patients should not have any uncontrolled illness including ongoing or active infection - Prior history of radiation therapy must be presented to study principal investigator (PI) for eligibility determination - Pregnant women are excluded from this study because total body irradiation is an agent with the potential for teratogenic or abortifacient effects - Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04380831
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

City of Hope Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jeffrey Y Wong
Principal Investigator Affiliation City of Hope Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherNIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Scleroderma
Additional Details

PRIMARY OBJECTIVES:

  • I. To assess the feasibility of using IMRT to deliver total body irradiation (TBI) to 800 cGy while keeping mean lung and kidney doses to 200 cGy.
  • II. To assess the safety/feasibility of total body irradiation using IMRT (IMRT TBI) in systemic sclerosis patients undergoing autologous hematopoietic stem cell transplantation.
SECONDARY OBJECTIVES:
  • I. To evaluate dose homogeneity and dose sparing to lung and kidneys.
  • II. To evaluate transplant-related mortality at 30 days and 100 days post IMRT TBI.
OUTLINE: Patients undergo TBI using IMRT twice daily (BID) on days -5 and -4 in the absence of disease progression or disease progression. Patients then receive cyclophosphamide on days -3 and -2 and undergo HSCT on day 0 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up on days 30 and 100.

Arms & Interventions

Arms

Experimental: Treatment (TBI using IMRT, cyclophosphamide, HSCT)

Patients undergo TBI using IMRT BID on days -5 and -4 in the absence of disease progression or disease progression. Patients then receive cyclophosphamide on days -3 and -2 and undergo HSCT on day 0 in the absence of disease progression or unacceptable toxicity.

Interventions

Procedure: - Allogeneic Hematopoietic Stem Cell Transplantation

Undergo HSCT

Drug: - Cyclophosphamide

Undergo HSCT

Radiation: - Intensity-Modulated Radiation Therapy

Undergo TBI using IMRT

Procedure: - Total-Body Irradiation

Undergo TBI using IMRT

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope Medical Center, Duarte, California

Status

Recruiting

Address

City of Hope Medical Center

Duarte, California, 91010

Site Contact

Jeffrey Y. Wong

[email protected]

626-218-2247