Donor Natural Killer Cells, Cyclophosphamide, and Etoposide in Treating Children and Young Adults With Relapsed or Refractory Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 32
Summary
- Conditions
- Recurrent Malignant Endocrine Neoplasm
- Recurrent Lip and Oral Cavity Carcinoma
- Recurrent Cutaneous Melanoma
- Recurrent Malignant Female Reproductive System Neoplasm
- Refractory Malignant Male Reproductive System Neoplasm
- Refractory Malignant Pharyngeal Neoplasm
- Recurrent Malignant Male Reproductive System Neoplasm
- Refractory Malignant Solid Neoplasm
- Refractory Malignant Thyroid Gland Neoplasm
- Recurrent Malignant Mesothelioma
- Refractory Malignant Endocrine Neoplasm
- Refractory Malignant Bone Neoplasm
- Refractory Malignant Neoplasm of Multiple Primary Sites
- Recurrent Malignant Neoplasm of Multiple Primary Sites
- Recurrent Malignant Oral Neoplasm
- Recurrent Malignant Pharyngeal Neoplasm
- Refractory Malignant Soft Tissue Neoplasm
- Refractory Cutaneous Melanoma
- Refractory Malignant Oral Neoplasm
- Recurrent Malignant Solid Neoplasm
- Recurrent Malignant Urinary System Neoplasm
- Refractory Malignant Skin Neoplasm
- Recurrent Malignant Thyroid Gland Neoplasm
- Recurrent Malignant Skin Neoplasm
- Refractory Malignant Urinary System Neoplasm
- Refractory Malignant Female Reproductive System Neoplasm
- Refractory Malignant Mesothelioma
- Recurrent Malignant Soft Tissue Neoplasm
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 1240 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. Determine the safety, maximum tolerated dose and/or recommended phase II dose of cord blood-derived expanded allogeneic natural killer cells (expanded allogeneic cord donor natural killer [NK] cells) following chemotherapy. SECONDARY OBJECTIVES: I. Determine the persistence of ...
PRIMARY OBJECTIVE: I. Determine the safety, maximum tolerated dose and/or recommended phase II dose of cord blood-derived expanded allogeneic natural killer cells (expanded allogeneic cord donor natural killer [NK] cells) following chemotherapy. SECONDARY OBJECTIVES: I. Determine the persistence of adoptively-transferred cord NK cells after solid tumor directed chemotherapy. II. Preliminarily define the antitumor activity to adoptively transferred NK cells following the study preparative regimen in the confines of a phase I study. III. Determine the immunophenotype and function of the infused NK cell product. IV. Preliminarily evaluate for any correlate of phenotype, killer cell immunoglobulin-like receptor (kir) haplotype, and function with overall response. OUTLINE: This is a dose escalation study of cord blood derived allogeneic NK cells. Patients receive cyclophosphamide intravenously (IV) once daily (QD) over 30 minutes and etoposide IV QD over 60 minutes on days 1-5 in the absence of unacceptable toxicity. Patients then receive cord blood derived allogeneic NK cells IV on day 8. After completion of study treatment, patients are followed up at 3-4 days, and then every week for 30 days.
Tracking Information
- NCT #
- NCT03420963
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Sajad Khazal M.D. Anderson Cancer Center
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