TheranosticTrials.org

Clinical Trial · NCT01476839

Radiolabeled Monoclonal Antibody Therapy and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Primary Refractory or Relapsed Hodgkin Lymphoma

Overview

This phase I clinical trial studies the side effects and best dose of radiolabeled monoclonal antibody therapy when given together with combination chemotherapy before stem cell transplant and to see how well it works in treating patients with primary refractory (did not respond to treatment) or relapsed (returned after treatment) Hodgkin lymphoma. Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving radiolabeled monoclonal antibody therapy together with combination chemotherapy may kill more cancer cells

Sponsor

City of Hope Medical Center

Phase

Phase 1

Contacts

Eileen Smith (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01476839

Drug / Compound

basiliximab/DOTA

Isotope(s):
Target(s):
  • CD25
Ligand Class: Antibodies
Chelator: DOTA

Eligibility

Inclusion

  • 1st relapsed HL in a patient who is not in CR after 2 cycles of salvage therapy
  • * Pathology confirmation of HL with City of Hope (COH) pathology review
  • PIF (primary induction failure): did not enter complete remission with first line of therapy; Note: a patient with PIF who responds to salvage therapy with a PR or CR is also eligible (and would be considered PIF-sensitive)
  • Hodgkin lymphoma that is:
  • Early 1st relapse: initial CR of \> 3 months and \< 12 months after 1st line chemotherapy

Exclusion

  • Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records by the radiation oncology PI; patients who have had prior external beam radiation \> 2000 cGy (at 180 to 200 cGy per day) to any portion of the lung will be ineligible; patients with ANY prior radiation to the heart are ineligible; patients with \> 500 cGy to any portion of the kidney will be excluded from the study
  • Prior high dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation
  • Myelodysplasia or any active malignancy other than HL, or \< 5 years remission from any other prior malignancy, except adequately treated basal cell or squamous cell carcinoma
  • Presence of antibody against basiliximab (only required for patients who have received prior antibody)
  • * Lymphocyte-predominant Hodgkin lymphoma